Cleared Traditional

K214002 - CRYOcheck Chromogenic Factor IX (FDA 510(k) Clearance)

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K214002 · Precision Biologic, Inc. · Hematology device
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Dec 2022
Decision
367d
Days
Class 2
Risk

K214002 is an FDA 510(k) clearance for the CRYOcheck Chromogenic Factor IX. Classified as Test, Qualitative And Quantitative Factor Deficiency (product code GGP), Class II - Special Controls.

Submitted by Precision Biologic, Inc. (Darmouth, CA). The FDA issued a Cleared decision on December 23, 2022 after a review of 367 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Precision Biologic, Inc. devices

Submission Details

510(k) Number K214002 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2021
Decision Date December 23, 2022
Days to Decision 367 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
254d slower than avg
Panel avg: 113d · This submission: 367d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 189
Devices cleared under the same product code (GGP) and FDA review panel - the closest regulatory comparables to K214002.
CRYOcheck Chromogenic Factor VIII
K251440 · Precision Biologic, Inc. · Aug 2025
HemosIL Chromogenic Factor IX
K230852 · Instrumentation Laboratory Company · Dec 2023
vWF Ag
K220728 · Siemens Healthcare Diagnostics Products GmbH · Jun 2023
HemosIL von Willebrand Factor Antigen
K223402 · Instrumentation Laboratory CO · Dec 2022
HemosIL von Willebrand Factor Antigen
K200033 · Instrumentation Laboratory CO · Aug 2020