Cleared Traditional

K782049 - BIOASSAY SYSTEM

K782049 is an FDA 510(k) clearance for BIOASSAY SYSTEM, manufactured by Abbott Laboratories. The device is a Class 2 Microbiology device with product code DJB cleared through the Traditional 510(k) pathway after a 263-day FDA review.

K782049 · Abbott Laboratories · Microbiology device
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Aug 1979
Decision
263d
Days
Class 2
Risk

K782049 is an FDA 510(k) clearance for the BIOASSAY SYSTEM, MS-2 SERUM. Classified as Radioimmunoassay, Gentamicin (125-i), Second Antibody Sep. (product code DJB), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on August 28, 1979 after a review of 263 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 862.3450 - the FDA microbiology 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Abbott Laboratories devices

FDA 510(k) Submission Details - K782049

510(k) Number K782049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1978
Decision Date August 28, 1979
Days to Decision 263 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
161d slower than avg
Panel avg: 102d · This submission: 263d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DJB Device Classification - Class 2, Special Controls

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 Microbiology 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 K782049.
COAT-A-COUNT GENTAMICIN RIA KIT
K811844 · Diagnostic Products Corp. · Jul 1981
QUANTIMUNE GENTAMICIN RIA GENTAMICIN
K791770 · Bio-Rad · Oct 1979
FLUOROMATIC GENTAMICIN FIA IMMUNOASSAY
K791547 · Bio-Rad · Oct 1979
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