Cleared Traditional

K972382 - UB ANALYZER UA-2, REAGENT KIT AND BILIRUBIN CONTROL

K972382 is an FDA 510(k) clearance for UB ANALYZER UA-2, manufactured by Arrows Co., Ltd.. The device is a Class 2 Chemistry device with product code CIG cleared through the Traditional 510(k) pathway after a 445-day FDA review.

K972382 · Arrows Co., Ltd. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1998
Decision
445d
Days
Class 2
Risk

K972382 is an FDA 510(k) clearance for the UB ANALYZER UA-2, REAGENT KIT AND BILIRUBIN CONTROL. Classified as Diazo Colorimetry, Bilirubin (product code CIG), Class II - Special Controls.

Submitted by Arrows Co., Ltd. (Osaka, JP). The FDA issued a Cleared decision on September 14, 1998 after a review of 445 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1110 - 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 Arrows Co., Ltd. devices

FDA 510(k) Submission Details - K972382

510(k) Number K972382 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1997
Decision Date September 14, 1998
Days to Decision 445 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
357d slower than avg
Panel avg: 88d · This submission: 445d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CIG Device Classification - Class 2, Special Controls

Product Code CIG Diazo Colorimetry, Bilirubin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1110
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.

Regulatory Peers - CIG Diazo Colorimetry, Bilirubin

All 213
Devices cleared under the same product code (CIG) and FDA review panel - the closest regulatory comparables to K972382.
BILIRUBIN, TOTAL AND DIRECT, PRODUCT NO, 122-01, 122-02, 122-03, 122-04
K991866 · A.P. Total Care, Inc. · Aug 1999
MODIFICATION TO ALCYON DIRECT BILIRUBIN
K991175 · Abbott Laboratories · May 1999
TBIL
K983133 · Abbott Laboratories · Sep 1998
DBIL
K981943 · Abbott Laboratories · Jul 1998
ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION LIQUID DIRECT BILIRUBIN REAGENT, CATALOG NUMBER 1877844
K981883 · Boehringer Mannheim Corp. · Jul 1998
CARESIDE TOTAL BILIRUBIN
K981588 · Careside, Inc. · Jun 1998