Cleared Traditional

K832720 - EMIT AED CARBAMAZEPINE ASSAY

K832720 is the FDA 510(k) clearance for EMIT AED CARBAMAZEPINE ASSAY by Syva Co.. It is a Class 2 Toxicology device (product code KLT) cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K832720 · Syva Co. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1983
Decision
53d
Days
Class 2
Risk

K832720 is an FDA 510(k) clearance for the EMIT AED CARBAMAZEPINE ASSAY. Classified as Enzyme Immunoassay, Carbamazepine (product code KLT), Class II - Special Controls.

Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on October 4, 1983 after a review of 53 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3645 - the FDA toxicology device 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 Syva Co. devices

Submission Details

510(k) Number K832720 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1983
Decision Date October 04, 1983
Days to Decision 53 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 87d · This submission: 53d
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 Toxicology devices follow this clearance model.

Regulatory Peers - KLT Enzyme Immunoassay, Carbamazepine

All 41
Devices cleared under the same product code (KLT) and FDA review panel - the closest regulatory comparables to K832720.
EMIT QST CARBAMAZEPINE ASSAY
K853835 · Syva Co. · Oct 1985
COBAS FP REAGENTS FOR CARBAMAZEPINE
K850807 · Roche Diagnostic Systems, Inc. · Mar 1985
CHEMKIT CARBAMAZEPINE DIAGNOSTIC KIT
K834052 · Abbott Laboratories · Jan 1984
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