Cleared Traditional

K083926 - CD4 COUNT

K083926 is an FDA 510(k) clearance for CD4 COUNT, manufactured by Streck. The device is a Class 2 Hematology device with product code GGL cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K083926 · Streck · Hematology device
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Feb 2009
Decision
42d
Days
Class 2
Risk

K083926 is an FDA 510(k) clearance for the CD4 COUNT. Classified as Control, White-cell (product code GGL), Class II - Special Controls.

Submitted by Streck (La Vista, US). The FDA issued a Cleared decision on February 11, 2009 after a review of 42 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 devices

FDA 510(k) Submission Details - K083926

510(k) Number K083926 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 2008
Decision Date February 11, 2009
Days to Decision 42 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 113d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GGL Device Classification - Class 2, Special Controls

Product Code GGL Control, White-cell
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 - GGL Control, White-cell

Devices cleared under the same product code (GGL) and FDA review panel - the closest regulatory comparables to K083926.
CD-CHEX PLUS BC
K051633 · Streck · Aug 2005
CD-CHEX CD 34
K993126 · Streck Laboratories, Inc. · Nov 1999
CD-CHEX + RBC
K960894 · Streck Laboratories, Inc. · May 1996
CD-CHEX CD4 LOW
K931825 · Streck Laboratories, Inc. · Jun 1994
CD-CHEX
K920997 · Streck Laboratories, Inc. · May 1992
COULTER POSITIVE CONTROL CELLS
K894651 · Coulter Corp. · Sep 1989