Cleared Traditional

K801492 - PORPHYRIN (ALA) DISK

K801492 is an FDA 510(k) clearance for PORPHYRIN (ALA) DISK, manufactured by Remel Co.. The device is a Class 1 Microbiology device with product code JTO cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K801492 · Remel Co. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1980
Decision
48d
Days
Class 1
Risk

K801492 is an FDA 510(k) clearance for the PORPHYRIN (ALA) DISK. 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

FDA 510(k) Submission Details - K801492

510(k) Number K801492 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.

JTO Device Classification - Class 1, General Controls

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 196
Devices cleared under the same product code (JTO) and FDA review panel - the closest regulatory comparables to K801492.
BETA LACTAMASE REAGENT DISK
K802566 · Carr-Scarborough Microbiologicals, Inc. · Oct 1980
API-CTS STREPTOCOCCUS
K801951 · Analytical Products, Inc. · Sep 1980
BACITRACIN DIFFERENTIATION DISC
K802127 · Biomedia, Inc. · Sep 1980
ALA SWAB
K801493 · Remel Co. · Aug 1980
AM-PEN SCREEN
K782086 · Pfizer, Inc. · Feb 1979
DISK, BETA-LACTAM
K790038 · Remel Co. · Jan 1979