Cleared Traditional

DRUG, INSURANCE, URINALYSIS, BLOOD/URINE TEST KITS (K931474) - FDA 510(k) Clearance

Class I Chemistry device.

K931474 · Gbf Medical Group · Chemistry device
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May 1994
Decision
412d
Days
Class 1
Risk

K931474 is an FDA 510(k) clearance for the DRUG, INSURANCE, URINALYSIS, BLOOD/URINE TEST KITS. Classified as Container, Specimen Mailer And Storage, Temperature Controlled, Sterile (product code KDW), Class I - General Controls.

Submitted by Gbf Medical Group (Greensboro, US). The FDA issued a Cleared decision on May 10, 1994 after a review of 412 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 864.3250 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Gbf Medical Group devices

Submission Details

510(k) Number K931474 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received March 24, 1993
Decision Date May 10, 1994
Days to Decision 412 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
324d slower than avg
Panel avg: 88d · This submission: 412d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KDW Container, Specimen Mailer And Storage, Temperature Controlled, Sterile
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.3250
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.