Cleared Traditional

K800986 - TRYPTICASE SOY AGAR W5% SHEEP BLOOD

K800986 is the FDA 510(k) clearance for TRYPTICASE SOY AGAR W5% SHEEP BLOOD by Quality Assurance Laboratory, Inc.. It is a Class 1 Microbiology device (product code JSG) cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K800986 · Quality Assurance Laboratory, Inc. · Microbiology device
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Jun 1980
Decision
40d
Days
Class 1
Risk

K800986 is an FDA 510(k) clearance for the TRYPTICASE SOY AGAR W5% SHEEP BLOOD. Classified as Culture Media, Non-selective And Non-differential (product code JSG), Class I - General Controls.

Submitted by Quality Assurance Laboratory, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 2, 1980 after a review of 40 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2300 - 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 Quality Assurance Laboratory, Inc. devices

Submission Details

510(k) Number K800986 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1980
Decision Date June 02, 1980
Days to Decision 40 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 102d · This submission: 40d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSG Culture Media, Non-selective And Non-differential
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2300
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 - JSG Culture Media, Non-selective And Non-differential

All 184
Devices cleared under the same product code (JSG) and FDA review panel - the closest regulatory comparables to K800986.
CDC ANAEROBE BLOOD AGAR
K803025 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1980
BHI AGAR/BHI BROTH BIPHASIC BLOOD CLT.BT
K802415 · Remel Co. · Oct 1980
ANAEROBE BLOOD AGAR
K802397 · Granite Diagnostics, Inc. · Oct 1980
TODD HEWITT BROTH
K792423 · Isle Media and Sterile Products, Inc. · Jan 1980
TRYPTIC SOY AGAR W/LECITHIN & POLYSRBTE.
K792594 · Isle Media and Sterile Products, Inc. · Dec 1979
TRYPTOSE BLOOD AGAR BASE & TRYPTOSE
K792543 · Isle Media and Sterile Products, Inc. · Dec 1979