Cleared Traditional

K880829 - GDS ENZYMATIC ACETAMINOPHEN REAGENT

K880829 is the FDA 510(k) clearance for GDS ENZYMATIC ACETAMINOPHEN REAGENT by Gds Technology, LLC. It is a Class 2 Toxicology device (product code LDP) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K880829 · Gds Technology, LLC · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1988
Decision
87d
Days
Class 2
Risk

K880829 is an FDA 510(k) clearance for the GDS ENZYMATIC ACETAMINOPHEN REAGENT. Classified as Colorimetry, Acetaminophen (product code LDP), Class II - Special Controls.

Submitted by Gds Technology, LLC (Elkhart, US). The FDA issued a Cleared decision on May 27, 1988 after a review of 87 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 Gds Technology, LLC devices

Submission Details

510(k) Number K880829 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1988
Decision Date May 27, 1988
Days to Decision 87 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 87d · This submission: 87d
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 28
Devices cleared under the same product code (LDP) and FDA review panel - the closest regulatory comparables to K880829.
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
ACETAZYME, STANBIO ACETAMINOPHEN PROC/TEST 0870
K851278 · Stanbio Laboratory · Apr 1985
EMIT QST ACETAMINOPHEN ASSAY
K844962 · Syva Co. · Jan 1985
ACA ACETAMINOPHEN ANALYTICAL TEST PACK
K842548 · E.I. Dupont DE Nemours & Co., Inc. · Aug 1984