Cleared Traditional

K801857 - DATA-ZYME LAT(GPT) PROCEDURE

K801857 is the FDA 510(k) clearance for DATA-ZYME LAT(GPT) PROCEDURE by Data Medical Associates, Inc.. It is a Class 1 Chemistry device (product code CKA) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K801857 · Data Medical Associates, Inc. · Chemistry device
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Sep 1980
Decision
43d
Days
Class 1
Risk

K801857 is an FDA 510(k) clearance for the DATA-ZYME LAT(GPT) PROCEDURE. Classified as Nadh Oxidation/nad Reduction, Alt/sgpt (product code CKA), Class I - General Controls.

Submitted by Data Medical Associates, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 16, 1980 after a review of 43 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 Data Medical Associates, Inc. devices

Submission Details

510(k) Number K801857 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1980
Decision Date September 16, 1980
Days to Decision 43 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
45d faster than avg
Panel avg: 88d · This submission: 43d
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 K801857.
ALT-QUANTICHROM
K812926 · Abbott Laboratories · Nov 1981
ULTRA ZYME PLUS GPT, #64956, 65035 & 36
K812591 · Harleco · Sep 1981
ALT (UV) TEST
K810355 · Boehringer Mannheim Corp. · Feb 1981
DURAZYME GPT/ALT
K800115 · American Monitor Corp. · Feb 1980
ALT REAGENT
K800038 · Gilford Diagnostics · Jan 1980
SGPT REAGENT SET MODIFICATION
K791641 · American Monitor Corp. · Sep 1979