Cleared Traditional

K844999 - PHADEBACT CSF TEST (FDA 510(k) Clearance)

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
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.

Device Classification

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.