# K872305: Irma-Count TSH RKTS1, RKTS2, RKTS5, Rktsx

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Products Corp.
- Decided: Jul 1, 1987 after 23 days
- Product code: JLW (Radioimmunoassay, Thyroid-Stimulating Hormone)
- Device class: 2
- Regulation: 21 CFR 862.1690
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Nov 28, 2012 · Class III · Z-0646-2013: The recall was initiated because Siemens Healthcare Diagnostics confirmed an under-recovery of dose values with some vials of Coat-A-Consta (CAC) IRMA TSH calibrators TSI4 (level B), TSI5 (level C), T
- Nov 28, 2012 · Class III · Z-0647-2013: The recall was initiated because Siemens Healthcare Diagnostics confirmed an under-recovery of dose values with some vials of Coat-A-Consta (CAC) IRMA TSH calibrators TSI4 (level B), TSI5 (level C), T
- Nov 28, 2012 · Class III · Z-0648-2013: The recall was initiated because Siemens Healthcare Diagnostics confirmed an under-recovery of dose values with some vials of Coat-A-Consta (CAC) IRMA TSH calibrators TSI4 (level B), TSI5 (level C), T

Source page: https://510kreport.com/device/K872305
Methodology: https://510kreport.com/methodology