Cleared Traditional

K844999 - PHADEBACT CSF TEST

K844999 is an FDA 510(k) clearance for PHADEBACT CSF TEST, manufactured by Pharmacia, Inc.. The device is a Class 2 Chemistry device with product code GTJ cleared through the Traditional 510(k) pathway after a 295-day FDA review.

K844999 · Pharmacia, Inc. · Chemistry device
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Oct 1985
Decision
295d
Days
Class 2
Risk

K844999 is an FDA 510(k) clearance for the PHADEBACT CSF TEST. Classified as Antisera, All Groups, N. Meningitidis (product code GTJ), Class II - Special Controls.

Submitted by Pharmacia, Inc. (Piscataway, US). The FDA issued a Cleared decision on October 17, 1985 after a review of 295 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.3390 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Pharmacia, Inc. devices

FDA 510(k) Submission Details - K844999

510(k) Number K844999 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 1984
Decision Date October 17, 1985
Days to Decision 295 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
207d slower than avg
Panel avg: 88d · This submission: 295d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GTJ Device Classification - Class 2, Special Controls

Product Code GTJ Antisera, All Groups, N. Meningitidis
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 Chemistry devices follow this clearance model.

Regulatory Peers - GTJ Antisera, All Groups, N. Meningitidis

All 14
Devices cleared under the same product code (GTJ) and FDA review panel - the closest regulatory comparables to K844999.
BACTIGEN(R) N. MENINGITIDIS
K885004 · Armkel, LLC · Feb 1989
WELLCOGEN N. MENINGITIDIS B/E. COLI K1 ZL24
K854851 · Wellcome Diagnostics · Feb 1986
WELLCOGEN BACTERIAL ANTIGEN KIT
K854852 · Wellcome Diagnostics · Feb 1986
WILLCOGEN MENINGITIDIS KIT ZL25
K851691 · Wellcome Diagnostics · Jun 1985
MENINGOCOCCUS GROUP B MONOCLONAL ANTIBODY ZM-51
K844762 · Wellcome Diagnostics · Jun 1985
DIRECTIGEN NEISSENA MENNINGITIDIS GROUP B TEST
K844407 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1985