Cleared Traditional

K896410 - CELLOGNOST SYPHILIS H

K896410 is an FDA 510(k) clearance for CELLOGNOST SYPHILIS H, manufactured by Behring Diagnostics, Inc.. The device is a Class 2 Microbiology device with product code GMT cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K896410 · Behring Diagnostics, Inc. · Microbiology device
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May 1990
Decision
189d
Days
Class 2
Risk

K896410 is an FDA 510(k) clearance for the CELLOGNOST SYPHILIS H. Classified as Antigens, Ha, Treponema Pallidum (product code GMT), Class II - Special Controls.

Submitted by Behring Diagnostics, Inc. (Somerville, US). The FDA issued a Cleared decision on May 15, 1990 after a review of 189 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3830 - 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 Behring Diagnostics, Inc. devices

FDA 510(k) Submission Details - K896410

510(k) Number K896410 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1989
Decision Date May 15, 1990
Days to Decision 189 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
87d slower than avg
Panel avg: 102d · This submission: 189d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GMT Device Classification - Class 2, Special Controls

Product Code GMT Antigens, Ha, Treponema Pallidum
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3830
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 - GMT Antigens, Ha, Treponema Pallidum

All 7
Devices cleared under the same product code (GMT) and FDA review panel - the closest regulatory comparables to K896410.
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OLYMPUS PK(TM) TP
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BACTO-HATTS
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AGGLUTINOTEST-SYPHILIS
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