Cleared Traditional

K193556 - Cryocheck Hex LA

K193556 is an FDA 510(k) clearance for Cryocheck Hex LA, manufactured by Precision Biologic. The device is a Class 2 Hematology device with product code GFO cleared through the Traditional 510(k) pathway after a 305-day FDA review.

K193556 · Precision Biologic · Hematology device
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Oct 2020
Decision
305d
Days
Class 2
Risk

K193556 is an FDA 510(k) clearance for the Cryocheck Hex LA. Classified as Activated Partial Thromboplastin (product code GFO), Class II - Special Controls.

Submitted by Precision Biologic (Darmouth, CA). The FDA issued a Cleared decision on October 23, 2020 after a review of 305 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7925 - 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 devices

FDA 510(k) Submission Details - K193556

510(k) Number K193556 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2019
Decision Date October 23, 2020
Days to Decision 305 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
192d slower than avg
Panel avg: 113d · This submission: 305d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GFO Device Classification - Class 2, Special Controls

Product Code GFO Activated Partial Thromboplastin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7925
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 - GFO Activated Partial Thromboplastin

All 43
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