Cleared Traditional

CARBAMEZEPINE REAGENT TEST KIT (K831222) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K831222 · Beckman Instruments, Inc. · Chemistry device
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May 1983
Decision
24d
Days
Class 2
Risk

K831222 is an FDA 510(k) clearance for the CARBAMEZEPINE REAGENT TEST KIT. Classified as Enzyme Immunoassay, Carbamazepine (product code KLT), Class II - Special Controls.

Submitted by Beckman Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 9, 1983 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3645 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Beckman Instruments, Inc. devices

Submission Details

510(k) Number K831222 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1983
Decision Date May 09, 1983
Days to Decision 24 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 88d · This submission: 24d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KLT Enzyme Immunoassay, Carbamazepine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3645
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - KLT Enzyme Immunoassay, Carbamazepine

All 32
Devices cleared under the same product code (KLT) and FDA review panel - the closest regulatory comparables to K831222.
AMES TDA DISOPYRAMIDE TEST
K832766 · Miles Laboratories, Inc. · Sep 1983
STRATUS CARBAMAZEPINE FLUROMETRIC
K832447 · American Dade · Sep 1983
A-GENT CARBAMAZEPINE
K832631 · Abbott Laboratories · Sep 1983
CARBAMAZEPINE ASSAY
K820189 · Syva Co. · Feb 1982
AMES TDA CARBAMAZEPINE TEST
K811952 · Miles Laboratories, Inc. · Jul 1981
CYBREX CARBAMAZEPINE
K802902 · Abbott Laboratories · Dec 1980