Cleared Traditional

K032804 - CRYOCHECK WEAK LUPUS POSITIVE CONTROL

K032804 is the FDA 510(k) clearance for CRYOCHECK WEAK LUPUS POSITIVE CONTROL by Precision Biologic. It is a Class 2 Hematology device (product code GGC) cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K032804 · Precision Biologic · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2003
Decision
55d
Days
Class 2
Risk

K032804 is an FDA 510(k) clearance for the CRYOCHECK WEAK LUPUS POSITIVE CONTROL. Classified as Control, Plasma, Abnormal (product code GGC), Class II - Special Controls.

Submitted by Precision Biologic (Dartmouth, N.S., CA). The FDA issued a Cleared decision on November 3, 2003 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5425 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Precision Biologic devices

Submission Details

510(k) Number K032804 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2003
Decision Date November 03, 2003
Days to Decision 55 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 113d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GGC Control, Plasma, Abnormal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5425
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 - GGC Control, Plasma, Abnormal

All 30
Devices cleared under the same product code (GGC) and FDA review panel - the closest regulatory comparables to K032804.
HEMOSIL LA POSITIVE CONTROL
K102552 · Instrumentation Laboratory CO · Apr 2011
SPECIALTY ASSAYED CONTROL-2
K100103 · Helena Laboratories · Dec 2010
CONTROL PLASMA P
K023312 · Dade Behring, Inc. · Nov 2002
LYPHOCHEK HEMOSTASIS, MODELS 798, 799
K020878 · Bio-Rad · Apr 2002
SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL
K020109 · Sigma Diagnostics, Inc. · Feb 2002
K-ASSAY D-DIMER CONTROLS
K012422 · Kamiya Biomedical Co. · Aug 2001