Cleared Traditional

K993033 - INTRAY GC

K993033 is an FDA 510(k) clearance for INTRAY GC, manufactured by Biomed Diagnostics, Inc.. The device is a Class 2 Microbiology device with product code JTY cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K993033 · Biomed Diagnostics, Inc. · Microbiology device
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Dec 1999
Decision
98d
Days
Class 2
Risk

K993033 is an FDA 510(k) clearance for the INTRAY GC. Classified as Culture Media, For Isolation Of Pathogenic Neisseria (product code JTY), Class II - Special Controls.

Submitted by Biomed Diagnostics, Inc. (San Jose, US). The FDA issued a Cleared decision on December 16, 1999 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2410 - 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.

View all Biomed Diagnostics, Inc. devices

FDA 510(k) Submission Details - K993033

510(k) Number K993033 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1999
Decision Date December 16, 1999
Days to Decision 98 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 102d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JTY Device Classification - Class 2, Special Controls

Product Code JTY Culture Media, For Isolation Of Pathogenic Neisseria
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.2410
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - JTY Culture Media, For Isolation Of Pathogenic Neisseria

All 59
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