Cleared Traditional

K792167 - 125 I FOLATE SOLID PHASE RADIOASSAY

K792167 is an FDA 510(k) clearance for 125 I FOLATE SOLID PHASE RADIOASSAY, manufactured by Abbott Laboratories. The device is a Class 2 Chemistry device with product code CGN cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K792167 · Abbott Laboratories · Chemistry device
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Nov 1979
Decision
18d
Days
Class 2
Risk

K792167 is an FDA 510(k) clearance for the 125 I FOLATE SOLID PHASE RADIOASSAY. Classified as Acid, Folic, Radioimmunoassay (product code CGN), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on November 13, 1979 after a review of 18 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K792167

510(k) Number K792167 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1979
Decision Date November 13, 1979
Days to Decision 18 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
70d faster than avg
Panel avg: 88d · This submission: 18d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CGN Device Classification - Class 2, Special Controls

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 54
Devices cleared under the same product code (CGN) and FDA review panel - the closest regulatory comparables to K792167.
'NO-BOIL' DUALCOUNT KIT
K810001 · Diagnostic Products Corp. · Jan 1981
FOLATE 125I RADIOIMMUNOASSAY
K803060 · Corning Medical & Scientific · Dec 1980
FOLATE RADIOASSAY KIT
K801198 · Calbiochem-Behring Corp. · Jul 1980
GAMMADAB (125 1) FOLATE RADIOASSAY KIT
K791079 · Clinical Assays, Inc. · Jul 1979
FOLATE REAGENT KIT, ARIA-II SYSTEM
K780557 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1978
QUANTITOPE 125I-FOLATE RADIOASSAY KIT
K780508 · Kallestad Laboratories, Inc. · May 1978