Cleared Traditional

K761058 - QUAN-8 MULT-COMP FACTOR VIII ASSAY KIT

K761058 is the FDA 510(k) clearance for QUAN-8 MULT-COMP FACTOR VIII ASSAY KIT by Bio/Data Corp.. It is a Class 2 Hematology device (product code GGP) cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K761058 · Bio/Data Corp. · Hematology device
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Feb 1977
Decision
81d
Days
Class 2
Risk

K761058 is an FDA 510(k) clearance for the QUAN-8 MULT-COMP FACTOR VIII ASSAY KIT. Classified as Test, Qualitative And Quantitative Factor Deficiency (product code GGP), Class II - Special Controls.

Submitted by Bio/Data Corp. (Mchenry, US). The FDA issued a Cleared decision on February 7, 1977 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7290 - 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 Bio/Data Corp. devices

Submission Details

510(k) Number K761058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1976
Decision Date February 07, 1977
Days to Decision 81 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 113d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GGP Test, Qualitative And Quantitative Factor Deficiency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7290
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.