Cleared Traditional

CAST SHOE, CAST BOOT (K830246) - FDA 510(k) Clearance

Class I Chemistry device.

K830246 · Warm & Form, Orthopedic Materials · Chemistry device
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Feb 1983
Decision
24d
Days
Class 1
Risk

K830246 is an FDA 510(k) clearance for the CAST SHOE, CAST BOOT. Classified as Kinetic Method, Gamma-glutamyl Transpeptidase (product code JQB), Class I - General Controls.

Submitted by Warm & Form, Orthopedic Materials (Mchenry, US). The FDA issued a Cleared decision on February 18, 1983 after a review of 24 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 Warm & Form, Orthopedic Materials devices

Submission Details

510(k) Number K830246 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1983
Decision Date February 18, 1983
Days to Decision 24 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 88d · This submission: 24d
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 20
Devices cleared under the same product code (JQB) and FDA review panel - the closest regulatory comparables to K830246.
Y-GLUTAMYLTRANSFERASE(Y-GT) REAGENT
K850319 · Sigma Diagnostics, Inc. · Feb 1985
SYSTEMATE 2GT - 67207
K843268 · Em Diagnostic Systems, Inc. · Sep 1984
PARAMAX & GLUTAMYTRANSFERASE REAGENT
K833001 · American Dade · Oct 1983
ULTRAZYME PLUS GAMMA GT(65055-65056)
K820233 · Harleco · Feb 1982
ULTRAZYME-GT, ITEM #64959 & 65032
K813041 · Harleco · Nov 1981
DIAGNOSTIC METHOD-8-GLUTAMYLTRANSFERASE
K761090 · Technicon Instruments Corp. · Dec 1976