Cleared Traditional

K896860 - OPUS CARBAMAZEPINE TEST SYSTEM

K896860 is the FDA 510(k) clearance for OPUS CARBAMAZEPINE TEST SYSTEM by Pb Diagnostic Systems, Inc.. It is a Class 2 Toxicology device (product code KLT) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K896860 · Pb Diagnostic Systems, Inc. · Toxicology device
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Jan 1990
Decision
28d
Days
Class 2
Risk

K896860 is an FDA 510(k) clearance for the OPUS CARBAMAZEPINE TEST SYSTEM. Classified as Enzyme Immunoassay, Carbamazepine (product code KLT), Class II - Special Controls.

Submitted by Pb Diagnostic Systems, Inc. (Westwood, US). The FDA issued a Cleared decision on January 2, 1990 after a review of 28 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 Pb Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K896860 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1989
Decision Date January 02, 1990
Days to Decision 28 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
59d faster than avg
Panel avg: 87d · This submission: 28d
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 K896860.
EMIT(R) 2000 CARBAMAZEPINE ASSAY/CALIBRATORS
K913066 · Syva Co. · Jul 1991
ENZYMUN TEST(R) T4 (TOTAL THYROXINE)
K901086 · Boehringer Mannheim Corp. · Mar 1990
EMIT CONVENIENCE PACK: CARBAMAZEPINE ASSAY
K897114 · Syva Co. · Jan 1990
EMIT QST CARBAMAZEPINE ASSAY
K882961 · Syva Co. · Aug 1988
ACCULEVEL CARBAMAZEPINE TEST
K871254 · Syva Co. · Jun 1987
EMIT CARBAMAZEPINE ASSAY
K871306 · Syva Co. · Apr 1987