Cleared Traditional

K013698 - AST (SGOT)

K013698 is an FDA 510(k) clearance for AST (SGOT), manufactured by Jas Diagnostics, Inc.. The device is a Class 2 Chemistry device with product code CIT cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K013698 · Jas Diagnostics, Inc. · Chemistry device
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Dec 2001
Decision
44d
Days
Class 2
Risk

K013698 is an FDA 510(k) clearance for the AST (SGOT). Classified as Nadh Oxidation/nad Reduction, Ast/sgot (product code CIT), Class II - Special Controls.

Submitted by Jas Diagnostics, Inc. (Miami, US). The FDA issued a Cleared decision on December 21, 2001 after a review of 44 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 Jas Diagnostics, Inc. devices

FDA 510(k) Submission Details - K013698

510(k) Number K013698 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2001
Decision Date December 21, 2001
Days to Decision 44 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 88d · This submission: 44d
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 130
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