Cleared Traditional

K812458 - PADAC

K812458 is the FDA 510(k) clearance for PADAC by Calbiochem-Behring Corp.. It is a Class 1 Microbiology device (product code JTO) cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K812458 · Calbiochem-Behring Corp. · Microbiology device
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Sep 1981
Decision
23d
Days
Class 1
Risk

K812458 is an FDA 510(k) clearance for the PADAC. Classified as Discs, Strips And Reagents, Microorganism Differentiation (product code JTO), Class I - General Controls.

Submitted by Calbiochem-Behring Corp. (Mchenry, US). The FDA issued a Cleared decision on September 23, 1981 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2660 - 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: 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 Calbiochem-Behring Corp. devices

Submission Details

510(k) Number K812458 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1981
Decision Date September 23, 1981
Days to Decision 23 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
79d faster than avg
Panel avg: 102d · This submission: 23d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JTO Discs, Strips And Reagents, Microorganism Differentiation
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JTO Discs, Strips And Reagents, Microorganism Differentiation

All 147
Devices cleared under the same product code (JTO) and FDA review panel - the closest regulatory comparables to K812458.
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K813442 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1981
MS-2 BACTERIAL IDENTIFICATION SYS
K813031 · Abbott Laboratories · Dec 1981
KANAMYCIN DISK
K812082 · Remel Co. · Aug 1981
BILE DISK
K812083 · Remel Co. · Aug 1981
SPS DISK
K812084 · Remel Co. · Aug 1981