Cleared Traditional

K811177 - QUANTA PHASE VITAMIN B-12/FOLATE RAD

K811177 is the FDA 510(k) clearance for QUANTA PHASE VITAMIN B-12/FOLATE RAD by Bio-Rad. It is a Class 2 Chemistry device (product code CGN) cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K811177 · Bio-Rad · Chemistry device
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May 1981
Decision
17d
Days
Class 2
Risk

K811177 is an FDA 510(k) clearance for the QUANTA PHASE VITAMIN B-12/FOLATE RAD. Classified as Acid, Folic, Radioimmunoassay (product code CGN), Class II - Special Controls.

Submitted by Bio-Rad (Mchenry, US). The FDA issued a Cleared decision on May 15, 1981 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1295 - the FDA in vitro diagnostics and chemistry 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 K811177 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1981
Decision Date May 15, 1981
Days to Decision 17 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 88d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CGN Acid, Folic, Radioimmunoassay
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1295
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 Chemistry devices follow this clearance model.

Regulatory Peers - CGN Acid, Folic, Radioimmunoassay

All 50
Devices cleared under the same product code (CGN) and FDA review panel - the closest regulatory comparables to K811177.
CIBA CORNING MAGIC LITE FOLATE IMMUNOASSAY
K893684 · Ciba Corning Diagnostics Corp. · Jul 1989
SOLID PHASE SIMUL TRAC VITAMIN B12
K822728 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 1982
VITAMIN B12/FOLATE DUAL RADIOASSAY KITS
K812979 · Amersham Corp. · Nov 1981
MICROMEDIC SYSTEMS' AUTOPAK
K810186 · Micromedic Systems · Feb 1981
'NO-BOIL' DUALCOUNT KIT
K810001 · Diagnostic Products Corp. · Jan 1981
FOLATE 125I RADIOIMMUNOASSAY
K803060 · Corning Medical & Scientific · Dec 1980