Cleared Traditional

K882636 - ALN DISCS

K882636 is an FDA 510(k) clearance for ALN DISCS, manufactured by Carr-Scarborough Microbiologicals, Inc.. The device is a Class 1 Microbiology device with product code JTO cleared through the Traditional 510(k) pathway after a 234-day FDA review.

K882636 · Carr-Scarborough Microbiologicals, Inc. · Microbiology device
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Feb 1989
Decision
234d
Days
Class 1
Risk

K882636 is an FDA 510(k) clearance for the ALN DISCS. Classified as Discs, Strips And Reagents, Microorganism Differentiation (product code JTO), Class I - General Controls.

Submitted by Carr-Scarborough Microbiologicals, Inc. (Stone Mountain, US). The FDA issued a Cleared decision on February 16, 1989 after a review of 234 days - an extended review 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: 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.

FDA 510(k) Submission Details - K882636

510(k) Number K882636 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 1988
Decision Date February 16, 1989
Days to Decision 234 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
132d slower than avg
Panel avg: 102d · This submission: 234d
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 243
Devices cleared under the same product code (JTO) and FDA review panel - the closest regulatory comparables to K882636.
ROSCO PYRR
K894221 · Pro-Lab, Inc. · Sep 1989
JAMES REAGENT
K890625 · Dms Products, Inc. · Feb 1989
PRO DISCS
K882630 · Carr-Scarborough Microbiologicals, Inc. · Feb 1989
B. CAT CONFIRM
K880694 · Scott Laboratories, Inc. · Jun 1988
PYR/ESCULIN DISK
K880950 · Remel Co. · Apr 1988
MUG-INDOLE DISC
K874933 · Scott Laboratories, Inc. · Jan 1988
K882636 · ALN DISCS
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