Cleared Traditional

K800115 - DURAZYME GPT/ALT

K800115 is the FDA 510(k) clearance for DURAZYME GPT/ALT by American Monitor Corp.. It is a Class 1 Chemistry device (product code CKA) cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K800115 · American Monitor Corp. · Chemistry device
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Feb 1980
Decision
26d
Days
Class 1
Risk

K800115 is an FDA 510(k) clearance for the DURAZYME GPT/ALT. Classified as Nadh Oxidation/nad Reduction, Alt/sgpt (product code CKA), Class I - General Controls.

Submitted by American Monitor Corp. (Mchenry, US). The FDA issued a Cleared decision on February 13, 1980 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1030 - 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 American Monitor Corp. devices

Submission Details

510(k) Number K800115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 1980
Decision Date February 13, 1980
Days to Decision 26 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
62d faster than avg
Panel avg: 88d · This submission: 26d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CKA Nadh Oxidation/nad Reduction, Alt/sgpt
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1030
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - CKA Nadh Oxidation/nad Reduction, Alt/sgpt

All 98
Devices cleared under the same product code (CKA) and FDA review panel - the closest regulatory comparables to K800115.
ULTRA ZYME PLUS GPT, #64956, 65035 & 36
K812591 · Harleco · Sep 1981
ALT (UV) TEST
K810355 · Boehringer Mannheim Corp. · Feb 1981
DATA-ZYME LAT(GPT) PROCEDURE
K801857 · Data Medical Associates, Inc. · Sep 1980
ALT REAGENT
K800038 · Gilford Diagnostics · Jan 1980
SGPT REAGENT SET MODIFICATION
K791641 · American Monitor Corp. · Sep 1979
SPIN CHEM, DETERMINATION OF ALT (GPT)
K791083 · Smithkline Diagnostics, Inc. · Jul 1979