Cleared Traditional

BLOOD GROUP SUBSTANCE A,B (K781896) - FDA 510(k) Clearance

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

K781896 · North American Biologicals, Inc. · Hematology device
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Dec 1978
Decision
44d
Days
Class 2
Risk

K781896 is an FDA 510(k) clearance for the BLOOD GROUP SUBSTANCE A,B. Classified as Substance, Blood Grouping Of Non-human Origin For In Vitro Diagnostic Use (product code KSX), Class II - Special Controls.

Submitted by North American Biologicals, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 20, 1978 after a review of 44 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.9160 - 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 North American Biologicals, Inc. devices

Submission Details

510(k) Number K781896 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 1978
Decision Date December 20, 1978
Days to Decision 44 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 113d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KSX Substance, Blood Grouping Of Non-human Origin For In Vitro Diagnostic Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.9160
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.