Cleared Traditional

K863053 - ALT S.C.E. (GPT)

K863053 is the FDA 510(k) clearance for ALT S.C.E. (GPT) by J. D. Assoc.. It is a Class 1 Chemistry device (product code CKA) cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K863053 · J. D. Assoc. · Chemistry device
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Dec 1986
Decision
120d
Days
Class 1
Risk

K863053 is an FDA 510(k) clearance for the ALT S.C.E. (GPT). Classified as Nadh Oxidation/nad Reduction, Alt/sgpt (product code CKA), Class I - General Controls.

Submitted by J. D. Assoc. (Montclair, US). The FDA issued a Cleared decision on December 10, 1986 after a review of 120 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all J. D. Assoc. devices

Submission Details

510(k) Number K863053 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1986
Decision Date December 10, 1986
Days to Decision 120 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
32d slower than avg
Panel avg: 88d · This submission: 120d
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 K863053.
WAKO(TM) AUTOKIT GPT
K864850 · Wako Chemicals USA, Inc. · Jan 1987
ALANINE AMINO TRANSFERASE ALT/SGPT
K864906 · Tech-Co, Inc. · Dec 1986
WAKO GPT II - HA
K864335 · Wako Chemicals USA, Inc. · Dec 1986
EMDS(TM) ALANINE AMINOTRANSFERASE (ALT) #67658/95
K863962 · Em Diagnostic Systems, Inc. · Nov 1986
ALT/GPT PROCEDURE
K863253 · Data Medical Associates, Inc. · Sep 1986
MODEL 303-47/303-48 ALANINE AMINOTRANSFERASE KIT
K862833 · Diagnostic Chemicals, Ltd. (Usa) · Aug 1986