Cleared Traditional

K780508 - QUANTITOPE 125I-FOLATE RADIOASSAY KIT

K780508 is the FDA 510(k) clearance for QUANTITOPE 125I-FOLATE RADIOASSAY KIT by Kallestad Laboratories, Inc.. It is a Class 2 Chemistry device (product code CGN) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K780508 · Kallestad Laboratories, Inc. · Chemistry device
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May 1978
Decision
34d
Days
Class 2
Risk

K780508 is an FDA 510(k) clearance for the QUANTITOPE 125I-FOLATE RADIOASSAY KIT. Classified as Acid, Folic, Radioimmunoassay (product code CGN), Class II - Special Controls.

Submitted by Kallestad Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 3, 1978 after a review of 34 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 Kallestad Laboratories, Inc. devices

Submission Details

510(k) Number K780508 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1978
Decision Date May 03, 1978
Days to Decision 34 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
54d faster than avg
Panel avg: 88d · This submission: 34d
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 K780508.
FOLATE RADIOASSAY KIT
K801198 · Calbiochem-Behring Corp. · Jul 1980
125 I FOLATE SOLID PHASE RADIOASSAY
K792167 · Abbott Laboratories · Nov 1979
FOLATE REAGENT KIT, ARIA-II SYSTEM
K780557 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1978
KIT, FOLATE RADIOASSAY SC.7
K760207 · Amersham Corp. · Jul 1976
PROCEDURE, RED CELL FOLATE ASSAY
K760133 · Bio-Rad · Jul 1976