Cleared Traditional

QUANTA-MATE VITAMIN B-12/FOLATE RA (K771047) - FDA 510(k) Clearance

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

K771047 · Bio-Rad · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
87d faster than avg
Panel avg: 104d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 77
Devices cleared under the same product code (CDD) and FDA review panel - the closest regulatory comparables to K771047.
ARCHITECT Active-B12 (Holotranscobalamin)
K233541 · Axis-Shield Diagnostics, Ltd. · Jul 2024
Access Vitamin B12
K223289 · Beckman Coulter, Inc. · Dec 2022
DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12
K190298 · Beckman Coulter Biomedical GmbH · Oct 2019
LIAISON Vitamin B12
K192064 · DiaSorin, Inc. · Oct 2019
Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access HYPERsensitive hTSH Assay, Power Express Sample Processing System Generic Connection Module and Access Immunoassay System Reagents
K140496 · Beckman Coulter, Inc. · Sep 2014
ARCHITECT B12
K121314 · Abbott Laboratories · May 2012