OEM/ODM Development & Validation
What it is
Turning a buyer specification — analyte, cut-off, packaging, branding — into a production-ready SKU.
How it works
Custom formulations are developed, then re-validated for cut-off, sensitivity and specificity before release.
Why it matters
OEM customization must be re-validated — changing cut-off or format changes performance, so each custom SKU is qualified independently.
Key components
- Custom formulation
- Cut-off design
- Re-validation
- Private-label packaging
Applications
- Custom formulation (analyte, cut-off)
- Private-label branding and packaging
- Registration support documents
What affects performance
- Cut-off design
- Re-validation after customization
- Packaging and labeling
Limitations
- Customization must be re-validated
- Changing cut-off or format changes performance
Common failure modes
- Unvalidated customization (cut-off / format change)
- Cut-off mismatch with the target market
- Packaging or labeling noncompliance
Frequently Asked Questions
What is OEM/ODM development? Turning a buyer specification into a production-ready SKU, re-validated for cut-off, sensitivity and specificity.
Related knowledge
References
- Posthuma-Trumpie GA, Korf J, van Amerongen A. Lateral flow (immuno)assay: its strengths, weaknesses, opportunities and threats. Anal Bioanal Chem. 2009;393(2):569-582.
- 胶体金免疫层析法定性检测试剂技术审评要点（NMPA technical review）. ivdmat.com.
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Written by the Progene Bio Technical Team · Last reviewed: 2026-09-12