Cleared Traditional

K833001 - PARAMAX & GLUTAMYTRANSFERASE REAGENT

K833001 is the FDA 510(k) clearance for PARAMAX & GLUTAMYTRANSFERASE REAGENT by American Dade. It is a Class 1 Chemistry device (product code JQB) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K833001 · American Dade · Chemistry device
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Oct 1983
Decision
63d
Days
Class 1
Risk

K833001 is an FDA 510(k) clearance for the PARAMAX & GLUTAMYTRANSFERASE REAGENT. Classified as Kinetic Method, Gamma-glutamyl Transpeptidase (product code JQB), Class I - General Controls.

Submitted by American Dade (Mchenry, US). The FDA issued a Cleared decision on October 14, 1983 after a review of 63 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 American Dade devices

Submission Details

510(k) Number K833001 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1983
Decision Date October 14, 1983
Days to Decision 63 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
25d faster than avg
Panel avg: 88d · This submission: 63d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JQB Kinetic 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 - JQB Kinetic Method, Gamma-glutamyl Transpeptidase

All 44
Devices cleared under the same product code (JQB) and FDA review panel - the closest regulatory comparables to K833001.
SYSTEMATE 2GT - 67207
K843268 · Em Diagnostic Systems, Inc. · Sep 1984
DART GAMMA-GT REAGENT SYSTEM
K834054 · Coulter Electronics, Inc. · Feb 1984
FLOW-PAC GGT REAGENT SET
K833029 · American Research Products Co. · Dec 1983
ULTRA ZYME PLUS GAMMA GT #65055 & 56
K830308 · Emd Chemicals, Inc. · Feb 1983
ULTRAZYME PLUS GAMMA GT-MCA #65055-65056
K830240 · Emd Chemicals, Inc. · Feb 1983
ULTRAZYME PLUS GAMMA-GT, #64959/65032
K823883 · Emd Chemicals, Inc. · Jan 1983