Cleared Traditional

K771047 - QUANTA-MATE VITAMIN B-12/FOLATE RA

K771047 is an FDA 510(k) clearance for QUANTA-MATE VITAMIN B-12/FOLATE RA, manufactured by Bio-Rad. The device is a Class 2 Immunology device with product code CDD cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K771047 · Bio-Rad · Immunology device
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Jun 1977
Decision
17d
Days
Class 2
Risk

K771047 is an FDA 510(k) clearance for the QUANTA-MATE VITAMIN B-12/FOLATE RA. Classified as Radioassay, Vitamin B12 (product code CDD), Class II - Special Controls.

Submitted by Bio-Rad (Mchenry, US). The FDA issued a Cleared decision on June 27, 1977 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1810 - the FDA immunology 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-Rad devices

FDA 510(k) Submission Details - K771047

510(k) Number K771047 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 1977
Decision Date June 27, 1977
Days to Decision 17 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 105d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CDD Device Classification - Class 2, Special Controls

Product Code CDD Radioassay, Vitamin B12
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1810
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 Immunology devices follow this clearance model.

Regulatory Peers - CDD Radioassay, Vitamin B12

All 66
Devices cleared under the same product code (CDD) and FDA review panel - the closest regulatory comparables to K771047.
RIANEN, VITAMIN B12 ASSAY SYSTEM
K792175 · New England Nuclear · Nov 1979
AUTO PAK VITAMIN B-12
K790347 · Micromedic Systems · Sep 1979
VITAMIN B12 RADIOASSAY
K780799 · Amersham Corp. · Jun 1978
VITAMIN B12 RADIOASSAY
K761321 · Kallestad Laboratories, Inc. · Mar 1977
RADIO IMMUNO ASSAY KIT/
K760619 · New England Nuclear · Dec 1976