Cleared Traditional

UBAS (K993941) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K993941 · Marukin Diagnostics · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2000
Decision
104d
Days
Class 2
Risk

K993941 is an FDA 510(k) clearance for the UBAS. Classified as Radioimmunoassay, Conjugated Sulfalithocholic (slcg) Acid, Bile Acids (product code KWX), Class II - Special Controls.

Submitted by Marukin Diagnostics (Irvine, US). The FDA issued a Cleared decision on March 2, 2000 after a review of 104 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1187 - 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 Marukin Diagnostics devices

Submission Details

510(k) Number K993941 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1999
Decision Date March 02, 2000
Days to Decision 104 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
16d slower than avg
Panel avg: 88d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWX Radioimmunoassay, Conjugated Sulfalithocholic (slcg) Acid, Bile Acids
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1187
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.