Cleared Traditional

K790249 - TEST CELLS (FDA 510(k) Clearance)

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

K790249 · Hyland Therapeutic Div., Travenol Laboratories · Hematology device
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May 1979
Decision
97d
Days
Class 2
Risk

K790249 is an FDA 510(k) clearance for the TEST CELLS. Classified as Kit, Quality Control For Blood Banking Reagents (product code KSF), Class II - Special Controls.

Submitted by Hyland Therapeutic Div., Travenol Laboratories (Mchenry, US). The FDA issued a Cleared decision on May 16, 1979 after a review of 97 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.9650 - 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 Hyland Therapeutic Div., Travenol Laboratories devices

Submission Details

510(k) Number K790249 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1979
Decision Date May 16, 1979
Days to Decision 97 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 113d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KSF Kit, Quality Control For Blood Banking Reagents
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.9650
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.