# K973536: Ace Phenobarbital Reagent/Aed Calibrators

- Pathway: 510(k) (Traditional)
- Applicant: Schiapparelli Biosystems, Inc.
- Decided: Nov 6, 1997 after 49 days
- Product code: DLJ (Calibrators, Drug Specific)
- Device class: 2
- Regulation: 21 CFR 862.3200
- 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 K946210 (1995). 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)
- K946210: Phenobarbital Enzyme Immunoassay, Diagnostic Reagents, Inc. (1995) Summary page 1.

## Indications for use
ACE® Phenobarbital Reagent is intended for the quantitative determination of phenobarbital in serum using the ACE® clinical chemistry analyzer. Since its discovery by Hauptmann in 1912, phenobarbital has been widely prescribed for the treatment of epilepsy, particularly for controlling focal motor or sensory and grand mal seizures. In combination with other clinical information, monitoring serum phenobarbital levels will provide physicians: with an essential tool to aid in adjusting dosage and achieving optimal therapeutic effect, while avoiding both subtherapeutic and harmful toxic drug levels.

Source page: https://510kreport.com/device/K973536
Methodology: https://510kreport.com/methodology