Cleared Traditional

K110212 - INRATIO2 PI/NR MONITORING SYSTEM

Also marketed or referenced as:
INRATIO PT/INR TEST STRIP

K110212 is an FDA 510(k) clearance for INRATIO2 PI/NR MONITORING SYSTEM, manufactured by Alere San Diego, Inc (Formally Biosite Incorporate. The device is a Class 2 Hematology device with product code GJS cleared through the Traditional 510(k) pathway after a 462-day FDA review.

K110212 · Alere San Diego, Inc (Formally Biosite Incorporate · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2012
Decision
462d
Days
Class 2
Risk

K110212 is an FDA 510(k) clearance for the INRATIO2 PI/NR MONITORING SYSTEM. Classified as Test, Time, Prothrombin (product code GJS), Class II - Special Controls.

Submitted by Alere San Diego, Inc (Formally Biosite Incorporate (San Diego, US). The FDA issued a Cleared decision on May 1, 2012 after a review of 462 days - an unusually long review period, suggesting complex equivalence evaluation.

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: 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 Hematology submissions.

View all Alere San Diego, Inc (Formally Biosite Incorporate devices

FDA 510(k) Submission Details - K110212

510(k) Number K110212 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received January 25, 2011
Decision Date May 01, 2012
Days to Decision 462 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
349d slower than avg
Panel avg: 113d · This submission: 462d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Hematology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT00933738 Completed Observational

Evaluation of the Accuracy of the INRatio Prothrombin Time (PT) Monitoring System With a New Test Strip for the Oral Anticoagulation Therapy Patient in the Presence of Heparin and Low Molecular Weight Heparin (e.g., Enoxaparin or Dalteparin)

150
Patients (est.)
12
Sites
Condition studied Coagulation
Eligibility All sexes · 18 Years+
Sponsor Abbott RDx Cardiometabolic
Started 2009-12-01 → Primary completion 2010-12-01 → Completed 2011-03-01
Study completed - no results published. This trial concluded in 2011 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

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 K110212.
Xprecia Stride Coagulation System, Xprecia System PT Controls
K151964 · Siemens Healthcare Diagnostics · Sep 2016
HEMOSIL RECOMBIPLASTIN 2G (8 ML VIAL)
K132722 · Instrumentation Laboratory CO · Jan 2014
HEMOSIL READIPLAS TIN
K122584 · Instrumentation Laboratory CO · Mar 2013
INRATIO/INRATIO2 TEST STRIPS
K092987 · Biosite Incorporated · Jun 2010
COAGUCHEK XS PRO SYSTEM
K093460 · Roche Diagnostics · Mar 2010
COAGUCHEK XS PLUS PST SYSTEM
K092940 · Roche Diagnostics Corp. · Mar 2010