Cleared Traditional

K781533 - SMA/GGT

K781533 is an FDA 510(k) clearance for SMA/GGT, manufactured by Technicon Instruments Corp.. The device is a Class 1 Chemistry device with product code JPZ cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K781533 · Technicon Instruments Corp. · Chemistry device
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Oct 1978
Decision
27d
Days
Class 1
Risk

K781533 is an FDA 510(k) clearance for the SMA/GGT. Classified as Colorimetric Method, Gamma-glutamyl Transpeptidase (product code JPZ), Class I - General Controls.

Submitted by Technicon Instruments Corp. (Mchenry, US). The FDA issued a Cleared decision on October 3, 1978 after a review of 27 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.

View all Technicon Instruments Corp. devices

FDA 510(k) Submission Details - K781533

510(k) Number K781533 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1978
Decision Date October 03, 1978
Days to Decision 27 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
61d faster than avg
Panel avg: 88d · This submission: 27d
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 27
Devices cleared under the same product code (JPZ) and FDA review panel - the closest regulatory comparables to K781533.
ULTRAZYME PLUS 2GT
K821871 · Harleco Diagnostics · Jul 1982
ULTRAZYME PLUS-GT, #64959 & 65032
K821468 · Emd Chemicals, Inc. · Jun 1982
COULTER ACCU-ZYME IIY-GT REAGENT KIT
K790812 · Coulter Electronics, Inc. · Jun 1979
ULTRAZYME PLUS GT
K780099 · Harleco · Mar 1978
REAGENT SYSTEM (NO. SC 135)
K760711 · Sigma Chemical Co. · Nov 1976
ULTRAZYME GT
K760025 · Harleco · Aug 1976