Cleared Traditional

UBAS MANUAL METHOD AND UBAS AUTOMATED METHOD (K980525) - FDA 510(k) Clearance

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

K980525 · Marukin Shoyu Co., Ltd. · Chemistry device
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Apr 1998
Decision
63d
Days
Class 2
Risk

K980525 is an FDA 510(k) clearance for the UBAS MANUAL METHOD AND UBAS AUTOMATED METHOD. Classified as Radioimmunoassay, Conjugated Sulfalithocholic (slcg) Acid, Bile Acids (product code KWX), Class II - Special Controls.

Submitted by Marukin Shoyu Co., Ltd. (Irvine, US). The FDA issued a Cleared decision on April 15, 1998 after a review of 63 days - a notably fast clearance cycle.

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: 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 Marukin Shoyu Co., Ltd. devices

Submission Details

510(k) Number K980525 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 1998
Decision Date April 15, 1998
Days to Decision 63 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
25d faster than avg
Panel avg: 88d · This submission: 63d
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.