Cleared Traditional

K931825 - CD-CHEX CD4 LOW (FDA 510(k) Clearance)

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K931825 · Streck Laboratories, Inc. · Hematology device
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Jun 1994
Decision
426d
Days
Class 2
Risk

K931825 is an FDA 510(k) clearance for the CD-CHEX CD4 LOW. Classified as Control, White-cell (product code GGL), Class II - Special Controls.

Submitted by Streck Laboratories, Inc. (Omaha, US). The FDA issued a Cleared decision on June 6, 1994 after a review of 426 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Hematology submissions.

View all Streck Laboratories, Inc. devices

Submission Details

510(k) Number K931825 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1993
Decision Date June 06, 1994
Days to Decision 426 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
313d slower than avg
Panel avg: 113d · This submission: 426d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.