# K170232: AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Boditech Med, Inc.
- Decided: Oct 13, 2017 after 261 days
- Product code: JLW (Radioimmunoassay, Thyroid-Stimulating Hormone)
- Device class: 2
- Regulation: 21 CFR 862.1690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K925637 (1993). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042281: Modification to Access Hypersensitive HTSH Assay, Beckman Coulter, Inc. (2004) Summary page 5.

## Indications for use
AFIAS TSH-SP, for use in conjunction with the AFIAS-6/SP Analyzer, is an immunofluorometric test system intended for in vitro diagnostic use at clinical laboratories and Point-of-Care (POC) sites for the quantitative measurement of thyroid stimulating hormone (TSH) levels in serum, sodium-heparinized plasma, or EDTA plasma samples. The test system is intended for use as an aid in the diagnosis of thyroid or pituitary disorders. AFIAS-6/SP Analyzer is a fluorescence-scanning instrument for in vitro diagnostic use at clinical laboratories and Point-of-Care (POC) sites in conjunction with various in vitro diagnostic AFIAS immunoassays for measuring the concentration of designated analytes in serum or plasma samples. AFIAS TSH-VB, for use in conjunction with the AFIAS-6/VB Analyzer, is an immunofluorometric test system intended for in vitro diagnostic use at clinical laboratories and Point-of-Care (POC) sites for the quantitative measurement of thyroid stimulating hormone (TSH) levels in sodium-heparinized or EDTA venous whole blood samples. The test system is intended for the monitoring of TSH levels in euthyroid and hypothyroid individuals. AFIAS-6/VB Analyzer is a fluorescence-scanning instrument for in vitro diagnostic use at clinical laboratories and Point-of-Care (POC) sites in conjunction with various in vitro diagnostic AFIAS immunoassays for measuring the concentration of designated analytes in venous whole blood samples.

Source page: https://510kreport.com/device/K170232
Methodology: https://510kreport.com/methodology