Cleared Traditional

K760711 - REAGENT SYSTEM (NO. SC 135)

K760711 is an FDA 510(k) clearance for REAGENT SYSTEM (NO. SC 135), manufactured by Sigma Chemical Co.. The device is a Class 1 Chemistry device with product code JPZ cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K760711 · Sigma Chemical Co. · Chemistry device
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Nov 1976
Decision
66d
Days
Class 1
Risk

K760711 is an FDA 510(k) clearance for the REAGENT SYSTEM (NO. SC 135). Classified as Colorimetric Method, Gamma-glutamyl Transpeptidase (product code JPZ), Class I - General Controls.

Submitted by Sigma Chemical Co. (Mchenry, US). The FDA issued a Cleared decision on November 30, 1976 after a review of 66 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1360 - 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.

FDA 510(k) Submission Details - K760711

510(k) Number K760711 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1976
Decision Date November 30, 1976
Days to Decision 66 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
23d faster than avg
Panel avg: 89d · This submission: 66d
Pathway characteristics
Predicate-based equivalence.

JPZ Device Classification - Class 1, General Controls

Product Code JPZ Colorimetric Method, Gamma-glutamyl Transpeptidase
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1360
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 - JPZ Colorimetric Method, Gamma-glutamyl Transpeptidase

All 32
Devices cleared under the same product code (JPZ) and FDA review panel - the closest regulatory comparables to K760711.
COULTER ACCU-ZYME IIY-GT REAGENT KIT
K790812 · Coulter Electronics, Inc. · Jun 1979
SMA/GGT
K781533 · Technicon Instruments Corp. · Oct 1978
ULTRAZYME PLUS GT
K780099 · Harleco · Mar 1978
REAGENT, Y-GT MAX-PACK
K760366 · Calbiochem · Nov 1976
ASSAY FOR GAMMA GLUTAMYLTRANSFERASE
K760346 · Princeton Biomedix · Oct 1976
ULTRAZYME GT
K760025 · Harleco · Aug 1976
K760711 · REAGENT SYSTEM (NO. SC 135)
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