Cleared Traditional

UROCYSTIN (K843382) - FDA 510(k) Clearance

Class I Chemistry device.

K843382 · Mission Pharmacal Co. · Chemistry device
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Jan 1985
Decision
133d
Days
Class 1
Risk

K843382 is an FDA 510(k) clearance for the UROCYSTIN. Classified as Nitroprusside Reaction (qualitative, Urine), Cystine (product code JLC), Class I - General Controls.

Submitted by Mission Pharmacal Co. (San Antonio, US). The FDA issued a Cleared decision on January 8, 1985 after a review of 133 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1240 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Mission Pharmacal Co. devices

Submission Details

510(k) Number K843382 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1984
Decision Date January 08, 1985
Days to Decision 133 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 88d · This submission: 133d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JLC Nitroprusside Reaction (qualitative, Urine), Cystine
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1240
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.