Cleared Traditional

K792460 - CALBIOCHEM-BEHRING RIA-COUNT

K792460 is an FDA 510(k) clearance for CALBIOCHEM-BEHRING RIA-COUNT, manufactured by Calbiochem-Behring Corp.. The device is a Class 2 Chemistry device with product code CDD cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K792460 · Calbiochem-Behring Corp. · Chemistry device
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Feb 1980
Decision
72d
Days
Class 2
Risk

K792460 is an FDA 510(k) clearance for the CALBIOCHEM-BEHRING RIA-COUNT. Classified as Radioassay, Vitamin B12 (product code CDD), Class II - Special Controls.

Submitted by Calbiochem-Behring Corp. (Mchenry, US). The FDA issued a Cleared decision on February 13, 1980 after a review of 72 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1810 - 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.

FDA 510(k) Submission Details - K792460

510(k) Number K792460 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1979
Decision Date February 13, 1980
Days to Decision 72 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
17d faster than avg
Panel avg: 89d · This submission: 72d
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 Chemistry 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 K792460.
VITAMIN B12 (57CO) RADIOIMMUNOASSAY
K802220 · Corning Medical & Scientific · Jan 1981
COMBOSTAT - NO-BOIL KIT
K801578 · Ria Products, Inc. · Oct 1980
VITAMIN B12 - NO-BOIL KIT
K801579 · Ria Products, Inc. · Oct 1980
CENTRIA VITAMIN B12 FOLATE RADIO SET
K791216 · Ventrex Laboratories, Inc. · Nov 1979
RIANEN, VITAMIN B12 ASSAY SYSTEM
K792175 · New England Nuclear · Nov 1979
AUTO PAK VITAMIN B-12
K790347 · Micromedic Systems · Sep 1979
K792460 · CALBIOCHEM-BEHRING RIA-COUNT
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