Cleared Traditional

K780557 - FOLATE REAGENT KIT, ARIA-II SYSTEM

K780557 is an FDA 510(k) clearance for FOLATE REAGENT KIT, manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic. The device is a Class 2 Immunology device with product code CGN cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K780557 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Immunology device
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May 1978
Decision
43d
Days
Class 2
Risk

K780557 is an FDA 510(k) clearance for the FOLATE REAGENT KIT, ARIA-II SYSTEM. Classified as Acid, Folic, Radioimmunoassay (product code CGN), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on May 18, 1978 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1295 - 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

FDA 510(k) Submission Details - K780557

510(k) Number K780557 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 1978
Decision Date May 18, 1978
Days to Decision 43 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
62d faster than avg
Panel avg: 105d · This submission: 43d
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 Immunology devices follow this clearance model.

Regulatory Peers - CGN Acid, Folic, Radioimmunoassay

All 57
Devices cleared under the same product code (CGN) and FDA review panel - the closest regulatory comparables to K780557.
FOLATE RADIOASSAY KIT
K801198 · Calbiochem-Behring Corp. · Jul 1980
125 I FOLATE SOLID PHASE RADIOASSAY
K792167 · Abbott Laboratories · Nov 1979
GAMMADAB (125 1) FOLATE RADIOASSAY KIT
K791079 · Clinical Assays, Inc. · Jul 1979
QUANTITOPE 125I-FOLATE RADIOASSAY KIT
K780508 · Kallestad Laboratories, Inc. · May 1978
IN VITRO FOLATE RADIOASSAY KIT
K771597 · Clinical Assays, Inc. · Sep 1977
KIT, FOLATE RADIOASSAY SC.7
K760207 · Amersham Corp. · Jul 1976