Cleared Traditional

K781725 - REAGENT SET

K781725 is the FDA 510(k) clearance for REAGENT SET by Medical Analysis Systems, Inc.. It is a Class 2 Chemistry device (product code CIT) cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K781725 · Medical Analysis Systems, Inc. · Chemistry device
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Nov 1978
Decision
23d
Days
Class 2
Risk

K781725 is an FDA 510(k) clearance for the REAGENT SET, U.V. ENZMATIC KINETIC, SGOT. Classified as Nadh Oxidation/nad Reduction, Ast/sgot (product code CIT), Class II - Special Controls.

Submitted by Medical Analysis Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 3, 1978 after a review of 23 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 Medical Analysis Systems, Inc. devices

Submission Details

510(k) Number K781725 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1978
Decision Date November 03, 1978
Days to Decision 23 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
65d faster than avg
Panel avg: 88d · This submission: 23d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 104
Devices cleared under the same product code (CIT) and FDA review panel - the closest regulatory comparables to K781725.
COULTER ACCU-ZYME II GOT REAGENT
K790483 · Coulter Electronics, Inc. · May 1979
SERUM, GLUTAMIC-OXALOACETIC
K790017 · Fisher Scientific Co., LLC · Feb 1979
AST
K781784 · Gilford Diagnostics · Jan 1979
SINGLE VIAL 10 SGOT-TRIS
K780634 · Boehringer Mannheim Corp. · May 1978
AST(GOT) UNI-UV, SGOT
K780463 · Sclavo, Inc. · May 1978
SGOT/AST REAGENT SYSTEM
K780443 · American Monitor Corp. · Apr 1978