Cleared Traditional

K023297 - URS-1B (BLOOD TEST)

K023297 is an FDA 510(k) clearance for URS-1B (BLOOD TEST), manufactured by Teco Diagnostics. The device is a Class 2 Chemistry device with product code JIO cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K023297 · Teco Diagnostics · Chemistry device
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Mar 2003
Decision
155d
Days
Class 2
Risk

K023297 is an FDA 510(k) clearance for the URS-1B (BLOOD TEST). Classified as Blood, Occult, Colorimetric, In Urine (product code JIO), Class II - Special Controls.

Submitted by Teco Diagnostics (Anaheim, US). The FDA issued a Cleared decision on March 6, 2003 after a review of 155 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 864.6550 - 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 Teco Diagnostics devices

FDA 510(k) Submission Details - K023297

510(k) Number K023297 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2002
Decision Date March 06, 2003
Days to Decision 155 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d slower than avg
Panel avg: 88d · This submission: 155d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JIO Device Classification - Class 2, Special Controls

Product Code JIO Blood, Occult, Colorimetric, In Urine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.6550
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 - JIO Blood, Occult, Colorimetric, In Urine

All 8
Devices cleared under the same product code (JIO) and FDA review panel - the closest regulatory comparables to K023297.
URITEST 10G & 11G URINE REAGENT STRIPS AND URITEST-50 AND URITEST-500B URINE ANALYZERS
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K083724 · Wiener Laboratorios Saic · Sep 2009
URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS
K040703 · Dirui Industrial Co., Ltd. · Aug 2004
BACTIDROP(TM) LACTOPHENOL ANILINE BLUE
K913005 · Remel Co. · Sep 1991
HEMASTIX REAGENT STRIPS
K905396 · Heraeus Kulzer, Inc. · Feb 1991