Tandem(R) M-Pak(Tm) Total B-Hcg Immunoenzy. Assay
510(k) K870521
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK870521 | Date8 Apr 1987 | StatusActive |
Recalls
-
- Terminated Z-2083-2018
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- JHI
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1155
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Tandem M-Pak Total B-HCG Immunoenzymatic Assay is a visual, prescription-use immunoassay device designed for the qualitative and quantitative detection of total beta-human chorionic gonadotropin (B-HCG) in serum or urine. It falls under the clinical chemistry category and is classified as a Class II device under FDA regulations, adhering to special controls for pregnancy-related diagnostic assays. The assay employs immunometric techniques to measure B-HCG levels, a key biomarker in pregnancy testing and monitoring.
This device is supplied as a single-use immunoassay kit, intended for use in clinical laboratory settings by trained personnel. It requires no special storage conditions beyond standard laboratory practices and is not intended for MRI environments. The assay is authorized under FDA 510(k) clearance (K870521) and is regulated under the product code JHI (Visual, Pregnancy Hcg, Prescription Use). No additional regulatory markings or sterility claims are specified in the data.
Other devices from Hybritech, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Tandem M-Pak Total B-HCG Immunoassay used for?
The Tandem M-Pak Total B-HCG Immunoassay is designed for the qualitative and quantitative detection of total beta-human chorionic gonadotropin (B-HCG) in serum or urine. B-HCG is a key biomarker used in pregnancy testing and monitoring, helping clinicians confirm or evaluate pregnancies by measuring hormone levels.
How is the Tandem M-Pak Total B-HCG Immunoassay supplied, and is it single-use?
The Tandem M-Pak Total B-HCG Immunoassay is supplied as a single-use immunoassay kit. Each kit is intended for one-time use in clinical laboratory settings by trained personnel, ensuring accuracy and preventing cross-contamination between tests.
Does the Tandem M-Pak Total B-HCG Immunoassay require special storage conditions?
No special storage conditions are required beyond standard laboratory practices. The kit should be stored in a way that maintains its integrity, such as at room temperature away from direct light and moisture, but no refrigeration or controlled-environment requirements are specified.
Is the Tandem M-Pak Total B-HCG Immunoassay intended for use in MRI environments?
No, the Tandem M-Pak Total B-HCG Immunoassay is explicitly not intended for use in MRI environments. This is because the kit contains materials that could be affected by magnetic fields, potentially compromising test accuracy or safety.
What regulatory approval does the Tandem M-Pak Total B-HCG Immunoassay hold?
The Tandem M-Pak Total B-HCG Immunoassay holds FDA 510(k) clearance under the reference number K870521. This clearance confirms that the device is substantially equivalent to a legally marketed predicate device and adheres to FDA regulations for pregnancy-related diagnostic assays, classified as a Class II device.