Cleared Traditional

K882961 - EMIT QST CARBAMAZEPINE ASSAY

K882961 is an FDA 510(k) clearance for EMIT QST CARBAMAZEPINE ASSAY, manufactured by Syva Co.. The device is a Class 2 Toxicology device with product code KLT cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K882961 · Syva Co. · Toxicology device
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Aug 1988
Decision
46d
Days
Class 2
Risk

K882961 is an FDA 510(k) clearance for the EMIT QST CARBAMAZEPINE ASSAY. Classified as Enzyme Immunoassay, Carbamazepine (product code KLT), Class II - Special Controls.

Submitted by Syva Co. (Palo Alto, US). The FDA issued a Cleared decision on August 29, 1988 after a review of 46 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

FDA 510(k) Submission Details - K882961

510(k) Number K882961 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1988
Decision Date August 29, 1988
Days to Decision 46 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
41d faster than avg
Panel avg: 87d · This submission: 46d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KLT Device Classification - Class 2, Special Controls

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 51
Devices cleared under the same product code (KLT) and FDA review panel - the closest regulatory comparables to K882961.
EMIT CONVENIENCE PACK: CARBAMAZEPINE ASSAY
K897114 · Syva Co. · Jan 1990
OPUS CARBAMAZEPINE TEST SYSTEM
K896860 · Pb Diagnostic Systems, Inc. · Jan 1990
INNOFLUOR CARBAMAZEPINE REAGENT SET
K893507 · Innotron of Oregon, Inc. · Aug 1989
CARBAMAZEPINE FPIA FLUORES. POLARIZA. IMMUNOASSAY
K873282 · Windsor Laboratories, Inc. · Sep 1987
ACCULEVEL CARBAMAZEPINE TEST
K871254 · Syva Co. · Jun 1987
EMIT CARBAMAZEPINE ASSAY
K871306 · Syva Co. · Apr 1987