Cleared Traditional

K022968 - ADVIA TESTPOINT CSF CONTROL

K022968 is the FDA 510(k) clearance for ADVIA TESTPOINT CSF CONTROL by Bayer Diagnostics Corp.. It is a Class 2 Hematology device (product code JPK) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K022968 · Bayer Diagnostics Corp. · Hematology device
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Sep 2002
Decision
18d
Days
Class 2
Risk

K022968 is an FDA 510(k) clearance for the ADVIA TESTPOINT CSF CONTROL. Classified as Mixture, Hematology Quality Control (product code JPK), Class II - Special Controls.

Submitted by Bayer Diagnostics Corp. (Tarrytown, US). The FDA issued a Cleared decision on September 24, 2002 after a review of 18 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 Bayer Diagnostics Corp. devices

Submission Details

510(k) Number K022968 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2002
Decision Date September 24, 2002
Days to Decision 18 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
95d faster than avg
Panel avg: 113d · This submission: 18d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 134
Devices cleared under the same product code (JPK) and FDA review panel - the closest regulatory comparables to K022968.
METER TRAX TRILEVEL, LOW LEVEL, MID LEVEL, HIGH LEVEL TRILEVEL MINIPAK
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K021922 · Streck Laboratories, Inc. · Jun 2002
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K013898 · R&D Systems, Inc. · Jan 2002