# K955638: Synthafax Aptt Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Diagnostic Systems, Inc.
- Decided: Apr 23, 1996 after 134 days
- Product code: GFO (Activated Partial Thromboplastin)
- Device class: 2
- Regulation: 21 CFR 864.7925
- Recalls of this device: 1 (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. The FDA summary names its predicate without a number.
- (no number) Activated THROMBOFAX Reagent-Optimized: named in the summary without a submission number

## Recalls of this device
- Nov 18, 2025 · Class III · Z-0938-2026: Recalled lots were manufactured with double the amount of preservative concentration.

## Indications for use
SynthAFax APTT Reagent is intended for the two-stage activated partial thromboplastin time (APTT) test, specific factor assays, APTT substitution test and monitoring heparin therapy.

Source page: https://510kreport.com/device/K955638
Methodology: https://510kreport.com/methodology