Cleared Traditional

K781674 - MACRO-VUE TEST

K781674 is the FDA 510(k) clearance for MACRO-VUE TEST by Bd Becton Dickinson Vacutainer Systems Preanalytic. It is a Class 2 Toxicology device (product code DJB) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K781674 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Toxicology device
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Nov 1978
Decision
43d
Days
Class 2
Risk

K781674 is an FDA 510(k) clearance for the MACRO-VUE TEST, GENTAMICIN. Classified as Radioimmunoassay, Gentamicin (125-i), Second Antibody Sep. (product code DJB), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on November 15, 1978 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3450 - the FDA toxicology 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

Submission Details

510(k) Number K781674 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1978
Decision Date November 15, 1978
Days to Decision 43 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 87d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DJB Radioimmunoassay, Gentamicin (125-i), Second Antibody Sep.
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3450
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 Toxicology devices follow this clearance model.

Regulatory Peers - DJB Radioimmunoassay, Gentamicin (125-i), Second Antibody Sep.

All 13
Devices cleared under the same product code (DJB) and FDA review panel - the closest regulatory comparables to K781674.
AMES TDA/GENTGMICIN
K790584 · Miles Laboratories, Inc. · Jun 1979
EMIT GENTAMICIN ASSAY
K790829 · Syva Co. · May 1979
RIA KIT, SISOMICIN
K782126 · Diagnostic Products Corp. · Feb 1979
AMINOGLYCOSIDE TEST SYSTEM
K772116 · Nichols Institute Diagnostics · Apr 1978
QUANTITOPE 125-I GENTAMICIN RIA KIT
K780323 · Kallestad Laboratories, Inc. · Mar 1978
AMINOGLYCOSIDE (125I) RIA KIT
K761157 · Diagnostic Products Corp. · Mar 1977