Chemelia Enzyme Immunoassay for TSH
by Boots-Celltech Diagnostics, Inc. 510(k)
Active
510(k) K873625
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK873625 | Date20 Oct 1987 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 5 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- JLM
- Device Class
- Class II
- Regulation
- 21 CFR Part 864.7360
- Advisory Committee
- Hematology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Chemelia Enzyme Immunoassay for TSH is an enzyme immunoassay designed for the quantitative measurement of thyroid-stimulating hormone (TSH) in serum or plasma. It operates on the principle of competitive binding, where TSH in the sample competes with a labeled TSH conjugate for binding sites on a specific antibody. This assay is classified under Isoenzymes, Electrophoretic, Glucose-6-Phosphate Dehydrogenase (product code JLM) and falls within the Hematology specialty, though its primary function is endocrine testing for TSH levels.
This assay is supplied as a reagent kit for in vitro diagnostic use in clinical laboratories. It is intended for single-use and requires no special sterility beyond standard laboratory practices. The device is not MRI-compatible and must be stored under refrigeration (2–8°C) as specified in the instructions. Authorized under FDA 510(k) clearance (K873625) as substantially equivalent to a predicate device, it adheres to 21 CFR 864.7360 regulatory standards for immunoassay systems.
Other devices from Boots-Celltech Diagnostics, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Chemelia Enzyme Immunoassay for TSH used for?
This assay measures thyroid-stimulating hormone (TSH) levels in serum or plasma samples. TSH is a key marker for thyroid function, helping diagnose conditions like hypothyroidism or hyperthyroidism. The competitive binding principle ensures accurate quantification by comparing patient TSH to a labeled conjugate for antibody binding.
How is the Chemelia TSH assay supplied, and is it reusable?
The assay comes as a reagent kit designed for single-use only in clinical laboratories. Each kit contains all necessary components for one test run, eliminating the need for reprocessing or reuse. This aligns with standard in vitro diagnostic practices to maintain accuracy and sterility.
What storage conditions are required for the Chemelia TSH kit?
The kit must be stored under refrigeration between 2–8°C to preserve reagent stability and performance. Avoid freezing or exposure to temperatures outside this range, as it may compromise assay accuracy. Follow the included instructions for proper handling and expiration checks.
Is the Chemelia TSH assay sterile, and what lab practices apply?
While the kit itself isn’t packaged in sterile barriers beyond standard laboratory packaging, it adheres to in vitro diagnostic sterility standards for clinical use. Users must follow aseptic techniques (e.g., disinfecting work surfaces, using sterile pipettes) during sample preparation to prevent contamination, as required for all immunoassays in regulated settings.
What regulatory pathway does the Chemelia TSH assay follow?
The assay received FDA 510(k) clearance (K873625) under the Traditional pathway, demonstrating substantial equivalence to a predicate device. It complies with 21 CFR 864.7360 for immunoassay systems and is classified under product code JLM (Isoenzymes, Electrophoretic). No additional approvals are implied beyond what’s stated in the data.