Pregnancy Test Empty Cassette: What Buyers Really Need to Know

If you build rapid tests, the humble empty abs plastic cassette is the chassis that makes your chemistry usable. I’ve toured enough molding shops to know: the difference between a clean, fast-assembling housing and a fiddly one shows up on your yield report—fast.

At a glance

Product: Pregnancy Test Empty Cassette (ABS). Origin: No.136, Shiji West Road, Gaobeidian City, 074000, Hebei Province, P.R. China. It’s widely used for HCG, multi-parameter human health tests, food safety strips, drug screening, and veterinary assays. Simple operation, top-and-bottom covers that actually match—sounds basic, but many customers say that’s what saves time.

Industry trends (quick reality check)

• Shorter design cycles: private-label tests launch in months, not years.
• Auditable supply chains: ISO 13485/9001 plants and RoHS/REACH materials are now table stakes.
• Assembly automation: consistent snap fit and low warp matter more than glossy marketing.

Process flow, materials, and testing

Material: medical-grade ABS (anti-yellowing, low VOC). Method: precision injection molding (hot runner, tight gate control), then top/bottom assembly via snap-fit or ultrasonic welding. QC: 100% visual window check, dimensional gauging, membrane fit test (3–4 mm strips), blue-dye leak challenge, and 1 m drop test on filled dummies. Standards referenced: ISO 13485 for manufacturing controls; ASTM D256 (Izod impact), ASTM D790 (flexural); packaging pre-shipment under ISTA 1A. Service life: around 5 years in dry storage at 10–30°C, RH

Product specifications (typical)

Informal test data I’ve seen: warp

Applications and field feedback

• Human health: HCG, LH, FSH, and combo infectious disease strips.
• Food test: aflatoxin and antibiotic residues—operators like the wider window.
• Drug test: multi-panel usability; stable sample well geometry.
• Animal health: parvo, brucella; surprisingly robust in barn conditions.

Many customers say the matte window boosts line clarity under cheap clinic lighting. To be honest, that tiny detail prevents a lot of helpdesk calls.

Vendor comparison (what buyers actually compare)

Case study (short)

A Southeast Asia assembler switched to this empty abs plastic cassette for an HCG line. By tightening tolerances on the membrane seat, their misalignment rejects fell from ~2.2% to 0.7%, and assembly time dropped ~12% over three months. Nothing flashy—just consistent molding and clean snap-fit.

Customization checklist

• Color coding by assay line; pantone-matched lids.
• Branding: pad print or embossed logo.
• Window geometry for single/multi-strip formats.
• Ultrasonic welding for splash resistance (drug test sites love this).

If you’re scaling, ask for PPAP-like documentation and lot traceability. And ensure the empty abs plastic cassette ships with RoHS/REACH statements plus an ISO 13485 cert copy.

Compliance and notes

The housing isn’t an IVD by itself, but it enters a regulated workflow. Most buyers align to ISO 13485, verify biocompatibility by risk assessment (limited contact), and pack under clean conditions. For EU launches, check IVDR labeling impact once your assay is integrated.

Citations

1. ISO 13485:2016 Medical devices — QMS requirements.
2. ASTM D256 Standard Test Methods for Determining the Izod Pendulum Impact Resistance of Plastics.
3. ASTM D790 Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics.
4. EU Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).
5. ISTA 1A: Non-Simulation Integrity Performance Test for Packaged-Products.