Cleared Traditional

VISION SGPT (ALT) (K861002) - FDA 510(k) Clearance

Class I Chemistry device.

K861002 · Abbott Laboratories · Chemistry device
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Apr 1986
Decision
34d
Days
Class 1
Risk

K861002 is an FDA 510(k) clearance for the VISION SGPT (ALT). Classified as Nadh Oxidation/nad Reduction, Alt/sgpt (product code CKA), Class I - General Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on April 21, 1986 after a review of 34 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 Abbott Laboratories devices

Submission Details

510(k) Number K861002 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1986
Decision Date April 21, 1986
Days to Decision 34 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
54d faster than avg
Panel avg: 88d · This submission: 34d
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 49
Devices cleared under the same product code (CKA) and FDA review panel - the closest regulatory comparables to K861002.
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
TWIN GOT-AST IFCC/GPT-ALT IFCC
K861792 · Boehringer Mannheim Corp. · Jul 1986
ALT(OPTIMIZED) REAGENT
K854502 · Sigma Diagnostics, Inc. · Nov 1985
ROCHE REAGENT FOR ALT
K843111 · Roche Diagnostic Systems, Inc. · Oct 1984
SYSTEMATE GPT 67209
K843334 · Em Diagnostic Systems, Inc. · Sep 1984