Cleared Traditional

K851278 - ACETAZYME

K851278 is the FDA 510(k) clearance for ACETAZYME by Stanbio Laboratory. It is a Class 2 Toxicology device (product code LDP) cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K851278 · Stanbio Laboratory · Toxicology device
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Apr 1985
Decision
16d
Days
Class 2
Risk

K851278 is an FDA 510(k) clearance for the ACETAZYME, STANBIO ACETAMINOPHEN PROC/TEST 0870. Classified as Colorimetry, Acetaminophen (product code LDP), Class II - Special Controls.

Submitted by Stanbio Laboratory (San Antonio, US). The FDA issued a Cleared decision on April 17, 1985 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3030 - 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 Stanbio Laboratory devices

Submission Details

510(k) Number K851278 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1985
Decision Date April 17, 1985
Days to Decision 16 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
71d faster than avg
Panel avg: 87d · This submission: 16d
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 Toxicology devices follow this clearance model.

Regulatory Peers - LDP Colorimetry, Acetaminophen

All 26
Devices cleared under the same product code (LDP) and FDA review panel - the closest regulatory comparables to K851278.
AXSYM ACETAMINOPHEN
K953094 · Abbott Laboratories · Aug 1995
ACETAMINOPHEN (ENZYMATIC RATE), NUMBER 502-13
K885097 · Diagnostic Chemicals, Ltd. (Usa) · Jan 1989
EASY-TEST EMIT ACETAMINOPHEN (ACTM) NO. 16653
K882719 · Em Diagnostic Systems, Inc. · Aug 1988
EMIT QST ACETAMINOPHEN ASSAY
K844962 · Syva Co. · Jan 1985
ACA ACETAMINOPHEN ANALYTICAL TEST PACK
K842548 · E.I. Dupont DE Nemours & Co., Inc. · Aug 1984
TDX ACETAMINOPHEN
K840941 · Abbott Laboratories · May 1984