Cleared Traditional

K020469 - CAL-CHEX CD PLUS

K020469 is the FDA 510(k) clearance for CAL-CHEX CD PLUS by Streck Laboratories, Inc.. It is a Class 2 Hematology device (product code KRX) cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K020469 · Streck Laboratories, Inc. · Hematology device
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Optimized for regulatory review, auditing and printing
Apr 2002
Decision
51d
Days
Class 2
Risk

K020469 is an FDA 510(k) clearance for the CAL-CHEX CD PLUS. Classified as Calibrator For Cell Indices (product code KRX), Class II - Special Controls.

Submitted by Streck Laboratories, Inc. (La Vista, US). The FDA issued a Cleared decision on April 4, 2002 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.8150 - 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

Submission Details

510(k) Number K020469 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2002
Decision Date April 04, 2002
Days to Decision 51 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
62d faster than avg
Panel avg: 113d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KRX Calibrator For Cell Indices
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.8150
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 - KRX Calibrator For Cell Indices

All 7
Devices cleared under the same product code (KRX) and FDA review panel - the closest regulatory comparables to K020469.
XN CAL
K160585 · Streck · Dec 2016
CD-CAL PLUS CALIBRATOR
K003991 · R&D Systems, Inc. · Jan 2001
CBC-CAL PLUS HEMATOLOGY CALIBRATOR
K955925 · R&D Systems, Inc. · Feb 1996
3K-CAL HEMATOLOGY CALIBRATOR/MULTIPLE
K912357 · R&D Systems, Inc. · Jul 1991
CBC-CAL (TM) PLUS/MULTIPLE
K862858 · R&D Systems, Inc. · Aug 1986
DADE HEMATOLOGY CALIBRATOR
K831140 · American Dade · Jun 1983