Cleared Traditional

K852992 - PARA CHECK (AKA EIGHT CHECK-C)

K852992 is an FDA 510(k) clearance for PARA CHECK (AKA EIGHT CHECK-C), manufactured by Streck Laboratories, Inc.. The device is a Class 2 Hematology device with product code JPK cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K852992 · Streck Laboratories, Inc. · Hematology device
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Oct 1985
Decision
87d
Days
Class 2
Risk

K852992 is an FDA 510(k) clearance for the PARA CHECK (AKA EIGHT CHECK-C). Classified as Mixture, Hematology Quality Control (product code JPK), Class II - Special Controls.

Submitted by Streck Laboratories, Inc. (Omaha, US). The FDA issued a Cleared decision on October 10, 1985 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.8625 - 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 Streck Laboratories, Inc. devices

FDA 510(k) Submission Details - K852992

510(k) Number K852992 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1985
Decision Date October 10, 1985
Days to Decision 87 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 113d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JPK Device Classification - Class 2, Special Controls

Product Code JPK Mixture, Hematology Quality Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.8625
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 - JPK Mixture, Hematology Quality Control

All 166
Devices cleared under the same product code (JPK) and FDA review panel - the closest regulatory comparables to K852992.
LYPHOCHEK GLYCATED HEMOGLOBIN/WHOLE BLOOD/LEV.I&II
K862186 · Bio-Rad · Jul 1986
VON WILLEBRAND FAC. DEFIC. ABNORMAL CONTROL PLASMA
K860751 · Bio/Data Corp. · Mar 1986
PLATELET-TROL II
K854353 · R&D Systems, Inc. · Nov 1985
MSI-HB HEMOGLOBIN CONTROL
K853776 · Medical Specialties, Inc. · Sep 1985
CELL-DYN BRAND HEMATOLOGY REAGENTS
K852372 · Abbott Diagnostics · Sep 1985
QUICK-COUNT HEMATOLOGY CONTROLS
K851663 · Seragen Diagnostics, Inc. · Jul 1985