# K994145: Vitros Immunodiagnostic Products Free T3 Reagent Pack, Vitros Immunodiagnostic Products Free T3 Calibrators

- Pathway: 510(k) (Special)
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: Dec 22, 1999 after 14 days
- Product code: JIS (Calibrator, Primary)
- Device class: 2
- Regulation: 21 CFR 862.1150
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K970016 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970016: Vitros Immunodiagnositcs Products-Free T3 Reagent Pack (Gem.1020)/Free T3 Calibrators (Gem.C020), Johnson & Johnson Clinical Diagnostics, Inc. (1997) Summary page 3.
- (no number) VITROS Immunodiagnostic Products Free T3 Reagent Pack (original formulation) and VITROS Immunodiagnostic Products Free T3 Calibrators (original formulation): named in the summary without a submission number

## Recalls of this device
- Apr 9, 2024 · Class II · Z-1818-2024: T3 Reagent Packs used with Free T3 Calibrators may produce positively biased results for patient and quality control samples. The positive bias may cause erroneous patient results or a delay in testin
- Apr 9, 2024 · Class II · Z-1819-2024: Free T3 Calibrators used with T3 Reagent Packs may produce positively biased results for patient and quality control samples. The positive bias may cause erroneous patient results or a delay in testin

## Indications for use
VITROS Free T3 Reagent Pack For in vitro diagnostic use only. The VITROS Free T3 Reagent Pack quantitatively measures free triiodothyronine (FT3) concentration in serum and plasma (EDTA or heparin) to aid in the differential diagnosis of thyroid disease. VITROS Free T3 Calibrators - For in vitro use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of Free T3 in serum and plasma (EDTA or heparin)

Source page: https://510kreport.com/device/K994145
Methodology: https://510kreport.com/methodology