Cleared Traditional

K860465 - VISION SGOT (AST) - ADDIT. OF WHOLE BLO...

K860465 is an FDA 510(k) clearance for VISION SGOT (AST) - ADDIT. OF WHOLE BLO..., manufactured by Abbott Laboratories. The device is a Class 2 Chemistry device with product code CIT cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K860465 · Abbott Laboratories · Chemistry device
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May 1986
Decision
88d
Days
Class 2
Risk

K860465 is an FDA 510(k) clearance for the VISION SGOT (AST) - ADDIT. OF WHOLE BLOOD CLAIM. Classified as Nadh Oxidation/nad Reduction, Ast/sgot (product code CIT), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on May 5, 1986 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1100 - 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

FDA 510(k) Submission Details - K860465

510(k) Number K860465 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 1986
Decision Date May 05, 1986
Days to Decision 88 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
At panel average
Panel avg: 88d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CIT Device Classification - Class 2, Special Controls

Product Code CIT Nadh Oxidation/nad Reduction, Ast/sgot
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1100
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 Chemistry devices follow this clearance model.

Regulatory Peers - CIT Nadh Oxidation/nad Reduction, Ast/sgot

All 116
Devices cleared under the same product code (CIT) and FDA review panel - the closest regulatory comparables to K860465.
SYSTEMATE (TM) ALANINE TRANSFERASE (ALT)
K863094 · Em Diagnostic Systems, Inc. · Aug 1986
MODEL 303-42/303-43 ASPARTATE AMINOTRANSFERASE KIT
K862832 · Diagnostic Chemicals, Ltd. (Usa) · Aug 1986
AST/GOT PROCEDURE
K861656 · Data Medical Associates, Inc. · May 1986
AST REAGENT CARTRIDGE
K861283 · Hi Chem, Inc. · Apr 1986
AST(GOT) (ASPARTATE AMINOTRANSFERASE) REAGENT
K860725 · Trace Scientific , Ltd. · Apr 1986
ASPARTATE AMINOTRANSFERASE (AST/SGOT) REAGENT SET
K860667 · Sterling Diagnostics, Inc. · Apr 1986