Cleared Traditional

K780099 - ULTRAZYME PLUS GT

K780099 is the FDA 510(k) clearance for ULTRAZYME PLUS GT by Harleco. It is a Class 1 Chemistry device (product code JPZ) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K780099 · Harleco · Chemistry device
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Mar 1978
Decision
48d
Days
Class 1
Risk

K780099 is an FDA 510(k) clearance for the ULTRAZYME PLUS GT. Classified as Colorimetric Method, Gamma-glutamyl Transpeptidase (product code JPZ), Class I - General Controls.

Submitted by Harleco (Mchenry, US). The FDA issued a Cleared decision on March 9, 1978 after a review of 48 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 Harleco devices

Submission Details

510(k) Number K780099 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 1978
Decision Date March 09, 1978
Days to Decision 48 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
40d faster than avg
Panel avg: 88d · This submission: 48d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 20
Devices cleared under the same product code (JPZ) and FDA review panel - the closest regulatory comparables to K780099.
ULTRAZYME PLUS-GT, #64959 & 65032
K821468 · Emd Chemicals, Inc. · Jun 1982
COULTER ACCU-ZYME IIY-GT REAGENT KIT
K790812 · Coulter Electronics, Inc. · Jun 1979
SMA/GGT
K781533 · Technicon Instruments Corp. · Oct 1978
REAGENT SYSTEM (NO. SC 135)
K760711 · Sigma Chemical Co. · Nov 1976
ULTRAZYME GT
K760025 · Harleco · Aug 1976