Cleared Traditional

K893507 - INNOFLUOR CARBAMAZEPINE REAGENT SET

K893507 is an FDA 510(k) clearance for INNOFLUOR CARBAMAZEPINE REAGENT SET, manufactured by Innotron of Oregon, Inc.. The device is a Class 2 Chemistry device with product code KLT cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K893507 · Innotron of Oregon, Inc. · Chemistry device
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Aug 1989
Decision
98d
Days
Class 2
Risk

K893507 is an FDA 510(k) clearance for the INNOFLUOR CARBAMAZEPINE REAGENT SET. Classified as Enzyme Immunoassay, Carbamazepine (product code KLT), Class II - Special Controls.

Submitted by Innotron of Oregon, Inc. (Portland, US). The FDA issued a Cleared decision on August 11, 1989 after a review of 98 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Innotron of Oregon, Inc. devices

FDA 510(k) Submission Details - K893507

510(k) Number K893507 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 1989
Decision Date August 11, 1989
Days to Decision 98 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
10d slower than avg
Panel avg: 88d · This submission: 98d
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 Chemistry devices follow this clearance model.

Regulatory Peers - KLT Enzyme Immunoassay, Carbamazepine

All 52
Devices cleared under the same product code (KLT) and FDA review panel - the closest regulatory comparables to K893507.
ENZYMUN TEST(R) T4 (TOTAL THYROXINE)
K901086 · Boehringer Mannheim Corp. · Mar 1990
EMIT CONVENIENCE PACK: CARBAMAZEPINE ASSAY
K897114 · Syva Co. · Jan 1990
OPUS CARBAMAZEPINE TEST SYSTEM
K896860 · Pb Diagnostic Systems, Inc. · Jan 1990
EMIT QST CARBAMAZEPINE ASSAY
K882961 · Syva Co. · Aug 1988
CARBAMAZEPINE FPIA FLUORES. POLARIZA. IMMUNOASSAY
K873282 · Windsor Laboratories, Inc. · Sep 1987
ACCULEVEL CARBAMAZEPINE TEST
K871254 · Syva Co. · Jun 1987