Cleared Traditional

K923971 - QC-CHEX

K923971 is an FDA 510(k) clearance for QC-CHEX, 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 102-day FDA review.

K923971 · Streck Laboratories, Inc. · Hematology device
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Optimized for regulatory review, auditing and printing
Nov 1992
Decision
102d
Days
Class 2
Risk

K923971 is an FDA 510(k) clearance for the QC-CHEX. 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 November 16, 1992 after a review of 102 days - within the typical 510(k) review window.

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: 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 Streck Laboratories, Inc. devices

FDA 510(k) Submission Details - K923971

510(k) Number K923971 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 1992
Decision Date November 16, 1992
Days to Decision 102 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
11d faster than avg
Panel avg: 113d · This submission: 102d
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 K923971.
SE-CHECK
K940181 · Streck Laboratories, Inc. · Mar 1994
CHECKPOINT
K931947 · Medical Specialties, Inc. · Jun 1993
COULTER RETIC-C CELL CONTROL
K930119 · Coulter Electronics, Inc. · Apr 1993
CBC-8K(TM) HEMATOLOGY CONTROL/MULTIPLE
K913879 · R&D Systems, Inc. · Nov 1991
PX COULTER(R) CELL CONTROL
K912133 · Coulter Electronics, Inc. · Jul 1991
RETIC-CHEX
K905524 · Streck Laboratories, Inc. · Feb 1991