Cleared Traditional

K070005 - HEMOSIL RECOMBIPLASTIN 2G

K070005 is an FDA 510(k) clearance for HEMOSIL RECOMBIPLASTIN 2G, manufactured by Instrumentation Laboratory CO. The device is a Class 2 Hematology device with product code GJS cleared through the Traditional 510(k) pathway after a 224-day FDA review.

K070005 · Instrumentation Laboratory CO · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2007
Decision
224d
Days
Class 2
Risk

K070005 is an FDA 510(k) clearance for the HEMOSIL RECOMBIPLASTIN 2G. Classified as Test, Time, Prothrombin (product code GJS), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on August 15, 2007 after a review of 224 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 Instrumentation Laboratory CO devices

FDA 510(k) Submission Details - K070005

510(k) Number K070005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2007
Decision Date August 15, 2007
Days to Decision 224 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
111d slower than avg
Panel avg: 113d · This submission: 224d
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 111
Devices cleared under the same product code (GJS) and FDA review panel - the closest regulatory comparables to K070005.
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
COAGUCHEK XS PLUS SYSTEM
K071041 · Roche Diagnostics · May 2007
COAGUCHEK XS SYSTEM
K062925 · Roche Diagnostics Corp. · Jan 2007
COAGUCHEK XS SYSTEM
K060978 · Roche Diagnostics · Aug 2006