# K981377: Ace T4 Reagent T4 Calibrators

- Pathway: 510(k) (Traditional)
- Applicant: Schiapparelli Biosystems, Inc.
- Decided: Jun 10, 1998 after 55 days
- Product code: KLI (Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine)
- Device class: 2
- Regulation: 21 CFR 862.1700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K944703 (1994). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944703: Thyroxine Enzyme Immunoassay, Diagnostic Reagents, Inc. (1994) Summary page 1.

## Most influential descendants
- K113437: Ace Hemoglobin Alc (Hbalc) Reagent, Ace Cedia T Uptake Reagent, Ace T4 Reagent, Ace Ferritin Reagent (2012), 1 descendant of its own
- K131515: Ace -GT Reagent; Ace Lipase Ragent; Ace T4 Reagent (2013), 0 descendants of its own

## Indications for use
ACE® T4 Reagent is used in the diagnosis and treatment of thyroid disorders. It is intended for the quantitative determination of thyroxine in serum using the ACE clinical chemistry analyzer.

Source page: https://510kreport.com/device/K981377
Methodology: https://510kreport.com/methodology