# K973582: Ace Primidone Reagent, Aed Calibrators

- Pathway: 510(k) (Traditional)
- Applicant: Schiapparelli Biosystems, Inc.
- Decided: Nov 12, 1997 after 51 days
- Product code: DJD (Enzyme Immunoassay, Primidone)
- Device class: 2
- Regulation: 21 CFR 862.3680
- 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 K960526 (1996). 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)
- K960526: Primidone Eia Test, Diagnostic Reagents, Inc. (1996) Summary page 1.

## Indications for use
ACE® Primidone Reagent is intended for the quantitative determination of primidone in serum using the ACE® clinical chemistry analyzer. Primidone (Mysoline®) used alone, or in combination with other anti- convulsants, is indicated in the control of grand mal, psychomotor, and focal epileptic seizures. In combination with other clinical data, monitoring serum primidone levels will provide physicians with useful information to aid in adjusting patient dosage to achieve optimal therapeutic effect while avoiding drug toxicity.

Source page: https://510kreport.com/device/K973582
Methodology: https://510kreport.com/methodology