Cleared Traditional

K230852 - HemosIL Chromogenic Factor IX

K230852 is an FDA 510(k) clearance for HemosIL Chromogenic Factor IX, manufactured by Instrumentation Laboratory Company. The device is a Class 2 Hematology device with product code GGP cleared through the Traditional 510(k) pathway after a 260-day FDA review.

K230852 · Instrumentation Laboratory Company · Hematology device
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Dec 2023
Decision
260d
Days
Class 2
Risk

K230852 is an FDA 510(k) clearance for the HemosIL Chromogenic Factor IX. Classified as Test, Qualitative And Quantitative Factor Deficiency (product code GGP), Class II - Special Controls.

Submitted by Instrumentation Laboratory Company (Bedford, US). The FDA issued a Cleared decision on December 13, 2023 after a review of 260 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7290 - 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 Company devices

FDA 510(k) Submission Details - K230852

510(k) Number K230852 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2023
Decision Date December 13, 2023
Days to Decision 260 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
147d slower than avg
Panel avg: 113d · This submission: 260d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GGP Device Classification - Class 2, Special Controls

Product Code GGP Test, Qualitative And Quantitative Factor Deficiency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7290
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 - GGP Test, Qualitative And Quantitative Factor Deficiency

All 134
Devices cleared under the same product code (GGP) and FDA review panel - the closest regulatory comparables to K230852.
CRYOcheck Chromogenic Factor VIII
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K220728 · Siemens Healthcare Diagnostics Products GmbH · Jun 2023
CRYOcheck Chromogenic Factor IX
K214002 · Precision Biologic, Inc. · Dec 2022
HemosIL von Willebrand Factor Antigen
K223402 · Instrumentation Laboratory CO · Dec 2022
HemosIL von Willebrand Factor Antigen
K200033 · Instrumentation Laboratory CO · Aug 2020
Cryocheck Chromogenic Factor VIII
K193204 · Precision Biologic · Jul 2020