Cleared Traditional

K122584 - HEMOSIL READIPLAS TIN

K122584 is the FDA 510(k) clearance for HEMOSIL READIPLAS TIN by Instrumentation Laboratory CO. It is a Class 2 Hematology device (product code GJS) cleared through the Traditional 510(k) pathway after a 212-day FDA review.

K122584 · Instrumentation Laboratory CO · Hematology device
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Mar 2013
Decision
212d
Days
Class 2
Risk

K122584 is an FDA 510(k) clearance for the HEMOSIL READIPLAS TIN. 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 March 24, 2013 after a review of 212 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

Submission Details

510(k) Number K122584 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2012
Decision Date March 24, 2013
Days to Decision 212 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
99d slower than avg
Panel avg: 113d · This submission: 212d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 75
Devices cleared under the same product code (GJS) and FDA review panel - the closest regulatory comparables to K122584.
CoaguChek Vantus System
K170960 · Roche Diagnostics · Dec 2017
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K151964 · Siemens Healthcare Diagnostics · Sep 2016
HEMOSIL RECOMBIPLASTIN 2G (8 ML VIAL)
K132722 · Instrumentation Laboratory CO · Jan 2014
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