Cleared Traditional

CAPITOL URINE DRUG SCREEN COLLECTION KIT (K951122) - FDA 510(k) Clearance

Class I Chemistry device.

K951122 · Harry A. Schlakman · Chemistry device
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May 1995
Decision
67d
Days
Class 1
Risk

K951122 is an FDA 510(k) clearance for the CAPITOL URINE DRUG SCREEN COLLECTION KIT. Classified as Container, Specimen Mailer And Storage, Temperature Controlled, Sterile (product code KDW), Class I - General Controls.

Submitted by Harry A. Schlakman (Elizabeth, US). The FDA issued a Cleared decision on May 5, 1995 after a review of 67 days - a notably fast clearance cycle.

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: 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 Harry A. Schlakman devices

Submission Details

510(k) Number K951122 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1995
Decision Date May 05, 1995
Days to Decision 67 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
21d faster than avg
Panel avg: 88d · This submission: 67d
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.