Cleared Traditional

K900546 - BARTELS NEISSERIA GONORRHOEAE DIRECT FLUORESCENT

K900546 is an FDA 510(k) clearance for BARTELS NEISSERIA GONORRHOEAE DIRECT FL..., manufactured by Baxter Healthcare Corp. The device is a Class 2 Microbiology device with product code GTH cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K900546 · Baxter Healthcare Corp · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1990
Decision
130d
Days
Class 2
Risk

K900546 is an FDA 510(k) clearance for the BARTELS NEISSERIA GONORRHOEAE DIRECT FLUORESCENT. Classified as Antiserum, Fluorescent (direct Test), All Groups, N. Gonorrhoeae (product code GTH), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Bellevue, US). The FDA issued a Cleared decision on June 15, 1990 after a review of 130 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3390 - 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 Baxter Healthcare Corp devices

FDA 510(k) Submission Details - K900546

510(k) Number K900546 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1990
Decision Date June 15, 1990
Days to Decision 130 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
28d slower than avg
Panel avg: 102d · This submission: 130d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GTH Device Classification - Class 2, Special Controls

Product Code GTH Antiserum, Fluorescent (direct Test), All Groups, N. Gonorrhoeae
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3390
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.