Cleared Traditional

K885097 - ACETAMINOPHEN (ENZYMATIC RATE)

K885097 is the FDA 510(k) clearance for ACETAMINOPHEN (ENZYMATIC RATE) by Diagnostic Chemicals, Ltd. (Usa). It is a Class 2 Chemistry device (product code LDP) cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K885097 · Diagnostic Chemicals, Ltd. (Usa) · Chemistry device
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Jan 1989
Decision
33d
Days
Class 2
Risk

K885097 is an FDA 510(k) clearance for the ACETAMINOPHEN (ENZYMATIC RATE), NUMBER 502-13. Classified as Colorimetry, Acetaminophen (product code LDP), Class II - Special Controls.

Submitted by Diagnostic Chemicals, Ltd. (Usa) (Monroe, US). The FDA issued a Cleared decision on January 11, 1989 after a review of 33 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3030 - 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 Diagnostic Chemicals, Ltd. (Usa) devices

Submission Details

510(k) Number K885097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1988
Decision Date January 11, 1989
Days to Decision 33 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 88d · This submission: 33d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LDP Colorimetry, Acetaminophen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3030
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 - LDP Colorimetry, Acetaminophen

All 27
Devices cleared under the same product code (LDP) and FDA review panel - the closest regulatory comparables to K885097.
ACETAMINOPHEN SERUM TOX EIA ASSAY
K961373 · Diagnostic Reagents, Inc. · Jul 1996
ACETAMINOPHEN ASSAY
K952949 · Diagnostic Chemicals , Ltd. · Sep 1995
AXSYM ACETAMINOPHEN
K953094 · Abbott Laboratories · Aug 1995
EASY-TEST EMIT ACETAMINOPHEN (ACTM) NO. 16653
K882719 · Em Diagnostic Systems, Inc. · Aug 1988
ACETAZYME, STANBIO ACETAMINOPHEN PROC/TEST 0870
K851278 · Stanbio Laboratory · Apr 1985
EMIT QST ACETAMINOPHEN ASSAY
K844962 · Syva Co. · Jan 1985