Cleared Traditional

BDPROBETEC ET CHLAMYDIA TRACHOMATIS AND NEISSERIA GONORRHOEAE AMPLIFIED DNA ASSAY (K984631) - FDA 510(k) Clearance

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

K984631 · Becton Dickinson Microbiology Systems · Microbiology device
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Nov 1999
Decision
309d
Days
Class 2
Risk

K984631 is an FDA 510(k) clearance for the BDPROBETEC ET CHLAMYDIA TRACHOMATIS AND NEISSERIA GONORRHOEAE AMPLIFIED DNA A.... Classified as Dna-reagents, Neisseria (product code LSL), Class II - Special Controls.

Submitted by Becton Dickinson Microbiology Systems (Sparks, US). The FDA issued a Cleared decision on November 4, 1999 after a review of 309 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Becton Dickinson Microbiology Systems devices

Submission Details

510(k) Number K984631 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1998
Decision Date November 04, 1999
Days to Decision 309 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
207d slower than avg
Panel avg: 102d · This submission: 309d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LSL Dna-reagents, Neisseria
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.

Regulatory Peers - LSL Dna-reagents, Neisseria

All 44
Devices cleared under the same product code (LSL) and FDA review panel - the closest regulatory comparables to K984631.
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LCX NEISSERIA GONORRHOEAE ASSAY
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