Cleared Traditional

K791473 - TRIPLE SUGAR IRON AGAR (TSI AGAR)

K791473 is the FDA 510(k) clearance for TRIPLE SUGAR IRON AGAR (TSI AGAR) by Isle Media and Sterile Products, Inc.. It is a Class 1 Microbiology device (product code JSE) cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K791473 · Isle Media and Sterile Products, Inc. · Microbiology device
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Aug 1979
Decision
26d
Days
Class 1
Risk

K791473 is an FDA 510(k) clearance for the TRIPLE SUGAR IRON AGAR (TSI AGAR). Classified as Culture Media, Multiple Biochemical Test (product code JSE), Class I - General Controls.

Submitted by Isle Media and Sterile Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 22, 1979 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2320 - 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 Isle Media and Sterile Products, Inc. devices

Submission Details

510(k) Number K791473 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1979
Decision Date August 22, 1979
Days to Decision 26 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
76d faster than avg
Panel avg: 102d · This submission: 26d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSE Culture Media, Multiple Biochemical Test
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2320
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 - JSE Culture Media, Multiple Biochemical Test

All 38
Devices cleared under the same product code (JSE) and FDA review panel - the closest regulatory comparables to K791473.
SIM MEDIUM
K792420 · Isle Media and Sterile Products, Inc. · Dec 1979
DECARBOXYLASE MOELLER BASE WITH OR WITH-
K792425 · Isle Media and Sterile Products, Inc. · Dec 1979
API 20E REAGENT QC
K791222 · Analytical Products, Inc. · Aug 1979
CARBOHYDRATE FERMENTATION MEDIA
K790617 · Anaerobe Systems · Apr 1979
PLATE, LD PRESUMPTO
K781856 · Anaerobe Systems · Nov 1978
API 50 E
K770989 · Analytical Products, Inc. · Jun 1977