Cleared Traditional

K801493 - ALA SWAB

K801493 is the FDA 510(k) clearance for ALA SWAB by Remel Co.. It is a Class 1 Microbiology device (product code JTO) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K801493 · Remel Co. · Microbiology device
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Aug 1980
Decision
48d
Days
Class 1
Risk

K801493 is an FDA 510(k) clearance for the ALA SWAB. Classified as Discs, Strips And Reagents, Microorganism Differentiation (product code JTO), Class I - General Controls.

Submitted by Remel Co. (Mchenry, US). The FDA issued a Cleared decision on August 13, 1980 after a review of 48 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 Remel Co. devices

Submission Details

510(k) Number K801493 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1980
Decision Date August 13, 1980
Days to Decision 48 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
54d faster than avg
Panel avg: 102d · This submission: 48d
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 144
Devices cleared under the same product code (JTO) and FDA review panel - the closest regulatory comparables to K801493.
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K802502 · Oxoid U.S.A., Inc. · Nov 1980
API-CTS STREPTOCOCCUS
K801951 · Analytical Products, Inc. · Sep 1980
PORPHYRIN (ALA) DISK
K801492 · Remel Co. · Aug 1980
DISK, BETA-LACTAM
K790038 · Remel Co. · Jan 1979
API ZYM
K781567 · Analytical Products, Inc. · Dec 1978
SUSPENSION SALINE, API 20E
K770926 · Analytical Products, Inc. · Jun 1977