Cleared Traditional

K092987 - INRATIO/INRATIO2 TEST STRIPS

K092987 is an FDA 510(k) clearance for INRATIO/INRATIO2 TEST STRIPS, manufactured by Biosite Incorporated. The device is a Class 2 Hematology device with product code GJS cleared through the Traditional 510(k) pathway after a 256-day FDA review.

K092987 · Biosite Incorporated · Hematology device
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Jun 2010
Decision
256d
Days
Class 2
Risk

K092987 is an FDA 510(k) clearance for the INRATIO/INRATIO2 TEST STRIPS. Classified as Test, Time, Prothrombin (product code GJS), Class II - Special Controls.

Submitted by Biosite Incorporated (San Diego, US). The FDA issued a Cleared decision on June 11, 2010 after a review of 256 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7750 - the FDA hematology device 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 Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Biosite Incorporated devices

FDA 510(k) Submission Details - K092987

510(k) Number K092987 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2009
Decision Date June 11, 2010
Days to Decision 256 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
143d slower than avg
Panel avg: 113d · This submission: 256d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GJS Device Classification - Class 2, Special Controls

Product Code GJS Test, Time, Prothrombin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7750
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 Hematology devices follow this clearance model.

Regulatory Peers - GJS Test, Time, Prothrombin

All 112
Devices cleared under the same product code (GJS) and FDA review panel - the closest regulatory comparables to K092987.
HEMOSIL RECOMBIPLASTIN 2G (8 ML VIAL)
K132722 · Instrumentation Laboratory CO · Jan 2014
HEMOSIL READIPLAS TIN
K122584 · Instrumentation Laboratory CO · Mar 2013
INRATIO2 PI/NR MONITORING SYSTEM
K110212 · Alere San Diego, Inc (Formally Biosite Incorporate · May 2012
COAGUCHEK XS PRO SYSTEM
K093460 · Roche Diagnostics · Mar 2010
COAGUCHEK XS PLUS PST SYSTEM
K092940 · Roche Diagnostics Corp. · Mar 2010
HANDHELD BASE UNIT
K072920 · Roche Diagnostics Corp. · Jan 2008