The world of rapid diagnostics and test devices is evolving rapidly, spurred by stringent quality demands, regulatory frameworks, cost optimization, and technological innovation. In this context, the empty abs plastic cassette — particularly the Empty Medical Diagnostic Cassette — stands as a backbone component in present-day lateral flow, immunochromatographic, and biochemical assays, serving as the structural housing for delicate test strips.
Industry Trends: Growth, Materials and Outlook for Plastic Diagnostic Cassettes
Global Lateral Flow Plastic Cassette Market Insights:
- Market Size: USD 1.4 Billion (2023, Source: Marketandresearch.biz)
- CAGR: 6.7% (2023–2028)
- Driving Factors: Infectious disease detection, decentralized diagnostic solutions, rising home/self-testing markets
ABS (Acrylonitrile Butadiene Styrene) is the most preferred material owing to its robust mechanical strength, cost-efficiency, excellent molding characteristics, and compliance with ISO 13485, FDA standards.
Defining Empty ABS Plastic Cassette & Core Product Segments
Empty ABS plastic cassettes serve as customizable, sterile housings engineered to securely accommodate diagnostic test strips. Their precision design guarantees minimal sample wastage, optimal fluid migration, and contaminant prevention throughout the test lifecycle.
Key Segments and Functions
Product |
Main Use |
Material |
Compatible Tests |
Customization |
Empty ABS Plastic Cassette |
Lateral Flow Assay (LFA) |
ABS (ISO 10993, FDA 21 CFR 177.1020 compliant) |
HCG, IgM, Drug-of-Abuse, Infectious Disease, Veterinary |
Yes |
Plastic Cassette for Test |
Urinalysis/Biochemical |
Polypropylene, ABS |
Glucose, Protein, Ketones etc. |
Yes |
Plastic Housing Cassettes |
Microfluidics/Immunoassay |
ABS, PC, Medical Grade PS |
COVID-19, FSH, LH, Troponin |
Yes, logo molding |
Manufacturing Process of Empty ABS Plastic Cassette
Stepwise Manufacturing Workflow (with ISO, FDA checkpoints):
- Raw Material Verification ISO 10993 →
Sourcing medical-grade ABS, verifying polymer batch against biocompatibility and FDA 21 CFR standards.
- Injection Molding Precision Mould →
Plastic melted and injected (via steel/Al CNC machined molds) to exacting CAD specs (<50 μm tolerance).
- Demolding & Cooling →
Automated cooled ejection ensures sharp definition and stress-free parts.
- Trimming & Deburring →
Manual/robotic edge smoothing to eliminate residue, with micro-particle vacuum cleaning.
- Dimensional QA Inspection ISO 13485 →
Automated vision systems check cavity clarity, port dimensions, and snap-fit function.
- Assembly & Ultrasonic Welding →
Top & bottom housings fused (where required) for hermetic seal integrity.
- Batch Sterilization & Final QC ANSI/AAMI/ISO 11137 →
Ethylene oxide (EtO) or gamma irradiation, biological indicator validation, final lot release.
- Packaging & Traceability
Cleanroom packaging (ISO 7/8) with batch/lot serialization for end-to-end supply chain tracking.
Need a process diagram? Watch this sample video: ABS Cassette Injection Molding Process
Diagram Key Nodes: Raw material → Injection → QA Testing → Assembly → Sterilization → Packaging
Technical Parameters Comparison Table: Empty ABS Plastic Cassette Industry Overview
Comparison of Main Technical Parameters (2024 Global Models)
Parameter |
Prises Bio |
Abbott (Reference) |
SD Biosensor (Reference) |
Generic Chinese OEM |
Main Material |
Virgin ABS, Medical-grade |
ABS/PP blend |
ABS (Sterile) |
Recycled ABS |
Color/Transparency |
White/Frosted, Opaque |
Milk-white, Semi-transp. |
White/Opaque |
Off-white, Lightly translucent |
Standard Sizes (mm) |
52x22, 60x26, Custom |
60x25 |
52x20, 60x26 |
50x20 |
Tolerances |
< ±0.05mm |
< ±0.10mm |
< ±0.08mm |
< ±0.15mm |
Certifications |
ISO 13485, FDA, CE |
ISO 13485 |
ISO 9001, CE |
— |
Operation Temp. |
-20°C ~ +65°C |
-10°C ~ +50°C |
-20°C ~ +60°C |
0°C ~ +45°C |
Surface Finish |
Matte, Low-gloss |
Satin/Gloss |
Smooth |
Rough/Irregular |
Lifespan (unopened) |
> 3 years |
2–3 years |
2 years |
1 year |
OEM/ODM Options |
Logo, Size, Color, Special Ports |
Branding only |
Size limited |
No |
As evidenced above, Prises Bio stands out for material purity, tighter tolerance, and full-range certifications. The empty abs plastic cassette from Prises Bio is especially suited for demanding medical and point-of-care contexts thanks to these technical strengths.
Main Technical Specs & Visualized Analysis
Empty Medical Diagnostic Cassette – Leading Specifications
Feature | Specification |
Material | Virgin ABS, Medical Grade |
Standard Sizes | 52x22, 60x26, 80x30 mm |
Color/Appearance | Matte White (customizable) |
Lateral Flow Compatibility | 3.5mm, 4mm, 5mm strips |
Snap-fit Accuracy | <±0.05mm |
Port/Cavity Options | Custom sample wells/multiple strip wells on request |
Certifications | ISO 13485, CE, FDA 21 CFR 177.1020 |
Surface | Low gloss, no burrs, homogeneous |
Sterility | Optional: EtO or gamma irradiated |
MOQ | 5000 pcs (negotiable for pilot lots) |
Data: Global Lateral Flow Cassette Material Composition, 2023 (ABS dominates with 66%, Source: MarketsandMarkets, 2023)
PrisesBio’s cassette: superior longevity, attributed to pure ABS & rigorous QA.
Source: Company datasheets, observation of market-available lateral flow plastic cassette models.
Application Scenarios and Technical Advantages
- Lateral Flow Test Kits – COVID-19 rapid antigen/antibody tests, HCG pregnancy, drug detection, fertility
- Veterinary Diagnostics – Pathogen, virus, or hormone detection in animal care
- Home/POC Testing – Glucose monitoring, ketone, urinalysis kits, infectious screening at home
- Environmental Monitoring – Water safety, pesticide residue screening using test strips in rugged ABS cassettes
- Clinical Chemistry – High-durability cassettes for use in automated analyzers, single/multi-well designs
Authoritative Endorsements & Industry Recognition:
- Tested and registered with CFDA, FDA, TGA for medical integration
- Meets ISO 13485:2016 for medical device quality management system
- Trusted by >30 international brands (Europe, Asia, North America)
- 5+ years continuous service to top IVD manufacturers
Custom Solutions: OEM & ODM for Plastic Cassette for Test
PrisesBio specializes in not just standard cassettes but also in high-precision, custom tailorable plastic cassette for test solutions to fit unique test geometries, strip numbers, specialty wells (single, double, triple), user branding (laser/silkscreen), color, and even RFID integration.
- Prototype in as fast as 10 days via rapid mold iteration
- Consultative engineering support: CAD/CAM co-design, material selection guidance
- Compliance support: Documentation, biocompatibility, shipment for global registrations
Case Studies: Plastic Housing Cassettes in Action
1. European Laboratory Chain (OEM, 2022):
- Challenge: Require a low-leakage, tamper-proof plastic housing cassette for high-volume COVID-19 test kits.
- Solution: Customized ABS cassette, dual-cavity, proprietary color, micro-textured surface, snap-tight fit.
- Outcome: Passed EN ISO 14971 risk analysis. Batch defect rate <0.04%. Won 'Preferred Supplier' award Q3/2022.
2. Southeast Asian Veterinary Chain (ODM, 2023):
- Challenge: Multi-format cassettes compatible with 3 sizes of animal test strips, anti-bacterial additive in plastic required.
- Solution: Antibacterial-treated ABS, customized multi-port cassette, high-force snap fit, color branding.
- Outcome: 60% reduction in user errors (internal validation), 20+ months shelf-life, no compatibility issues.
3. Public Health Procurement (Govt. tender, 2024):
- Required: Ultra-sterile, serialized cassettes for malaria and dengue LFA testing in tropical field clinics.
- Solution: EtO-sterile ABS cassettes, tamper-evident packaging, QR-coded batch traceability.
- End Result: Seamless delivery of 1.6 million units. Zero recall incidents, project renewed for next cycle.
Delivery, Warranty, and Customer Support
- Typical Lead Time: 2–3 weeks for stock models; 3–6 weeks for OEM/ODM.
- Warranty: 2 years material/fit warranty (defect-free on delivery and intended storage).
- Traceability: Full traceability via batch/serial codes, available for recall or compliance audits.
- Customer Support: Live technical experts (English/Chinese), comprehensive post-sales support, root cause analysis, and rapid complaint response (<24h business day).
- Confidentiality: NDAs for all custom projects. Private labeling is available.
- Logistics: Export-compliant, sterile-packaging, air/sea shipment options, documents supplied for cross-border medical device clearance.
FAQ – Professional FAQ on Empty ABS Plastic Cassette
1. What is "ABS" and why is it superior for diagnostic cassettes?
ABS (Acrylonitrile Butadiene Styrene) is a thermoplastic polymer known for optimal impact strength, dimensional stability, and biocompatibility. It's the leading choice due to sterilization compatibility, less sample absorption, and ISO/FDA acceptance in medical devices.
2. What are the standard sizes and customization limits for empty abs plastic cassette?
Standard: 52x22mm, 60x26mm, and 80x30mm. Custom: up to 200mm length, multi-well, variable port, custom colors, and branding are all supported. Additional geometries can be CNC-prototyped.
3. Which international standards do these plastic cassette for test products adhere to?
ISO 13485 (QMS for medical devices), FDA 21 CFR 177.1020 (materials for food contact), and, for sterile versions, ANSI/AAMI/ISO 11137 (sterilization validation).
4. How is sterility validated for these products?
Sterilization is performed by EtO or gamma irradiation, validated by biological indicators and regular batch sterility testing as per ANSI/ISO regulations. Test reports available upon request.
5. How do lateral flow plastic cassette tolerances affect assay performance?
Tighter mechanical tolerances (<±0.05mm) reduce the risk of capillary failure, prevent fluid leakage, and ensure consistent, reproducible diagnostic result lines. This is essential for regulatory compliance in diagnostic accuracy.
6. Are your plastic housing cassettes compatible with automated analyzers?
Yes, all models can be designed for robotic handling: specific grip tabs, unique barcoding/QR code spaces, and stackable profiles are available for automation compatibility.
7. What kind of product testing and traceability do you offer?
Each lot undergoes full visual, dimensional, and functional QA. Traceability is implemented through batch/barcode/QR code serialization, and all shipments accompanied by a full COA (Certificate of Analysis).
Why Choose Empty Medical Diagnostic Cassette from PrisesBio?
- Unmatched purity, ISO/FDA/CE certified material
- Industry-low defect rate (<0.05%)
- Custom engineering support, from ideation to commercialization
- Flexible logistics and MOQ — global delivery, trackable consignments
- Trusted partner of 30+ top diagnostic brands
How to Get the Best Empty ABS Plastic Cassette Solution?
- Get in touch via product page for instant quote or custom project discussion.
- Consult on CAD, rapid prototyping, regulatory documentation, and compliance support.
- Sample kits delivered globally for parallel testing and validation.
References & Further Reading