# K973517: Vitros Immunodiagnostic Products Range Verifiers

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson Clinical Diagnostics, Inc.
- Decided: Sep 25, 1997 after 8 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
17 later devices descend from it; 8 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K992349: Vitros Immunodiagnostic Products Troponin I Range Verifiers (1999), 4 descendants of its own
- K990984: Vitros Immunodiagnostic Products Cea Range Verifiers (1999), 3 descendants of its own
- K062838: Vitros Troponin I ES Assay, Including Reagent Pack, Calibrators and Range Verifiers, Models 680 2301, 2302 and 2303 (2006), 2 descendants of its own
- K063720: Vitros Immunodiagnostic Products Total B-HCG II Reagent Pack, Calibrators, Range Verifiers (2007), 1 descendant of its own
- K041322: Vitros Immunodiagnostic Products Cea Reagent Pack/Calibrator/Range Verifiers (2004), 1 descendant of its own

## Indications for use
For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of immunoassays which include TSH, Total T4. Total T3, T3 Uptake, LH, Progesterone, FSH, Total BhCG, Free T3 and Prolactin.

Source page: https://510kreport.com/device/K973517
Methodology: https://510kreport.com/methodology