Cleared Traditional

MACRO-VUE CARD TEST (K810597) - FDA 510(k) Clearance

Class II Toxicology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K810597 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Toxicology device

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Mar 1981

Decision

11d

Days

Class 2

Risk

K810597 is an FDA 510(k) clearance for the MACRO-VUE CARD TEST. Classified as Radioimmunoassay, Tobramycin (product code KLB), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on March 17, 1981 after a review of 11 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3900 - 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	K810597 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 06, 1981
Decision Date	March 17, 1981
Days to Decision	11 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

76d faster than avg

Panel avg: 87d · This submission: 11d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	KLB Radioimmunoassay, Tobramycin
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 862.3900

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 - KLB Radioimmunoassay, Tobramycin

All 14

Devices cleared under the same product code (KLB) and FDA review panel - the closest regulatory comparables to K810597.

ACA TOBRAMY-CIN ANALYTICAL TEST PACK

K852671 · E.I. Dupont DE Nemours & Co., Inc. · Jul 1985

TOBRAMYCIN ANALYTICAL TEST PACK-ACA

K832985 · E.I. Dupont DE Nemours & Co., Inc. · Oct 1983

COAT-A-COUNT TOBRAMYCIN RIA KIT

K822858 · Diagnostic Products Corp. · Oct 1982

FLUOROMATIC TOBRAMYCIN FIA IMMUNOASSAY

K791596 · Bio-Rad · Oct 1979

QUANTIMUNE TOBRAMYCIN RIA RADIOIMMUNO

K791502 · Bio-Rad · Sep 1979

AMES TDA/TOBRAMYCIN

K791435 · Miles Laboratories, Inc. · Aug 1979

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K810597

Bd Becton Dickinson Vacutainer Systems Preanalytic

Washington, DC · US

Regulatory profile

632 submissions 625 cleared

99% clearance rate · Active in Toxicology

Data Intelligence Layer

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Sourced from FDA 510(k) public files . Updated monthly.

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