Cleared Traditional

K241427 - Access Syphilis

K241427 is the FDA 510(k) clearance for Access Syphilis by Beckman Coulter, Inc.. It is a Class 2 Microbiology device (product code LIP) cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K241427 · Beckman Coulter, Inc. · Microbiology device
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Sep 2024
Decision
109d
Days
Class 2
Risk

K241427 is an FDA 510(k) clearance for the Access Syphilis. Classified as Enzyme Linked Immunoabsorption Assay, Treponema Pallidum (product code LIP), Class II - Special Controls.

Submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on September 6, 2024 after a review of 109 days - within the typical 510(k) review window.

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 Beckman Coulter, Inc. devices

Submission Details

510(k) Number K241427 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2024
Decision Date September 06, 2024
Days to Decision 109 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 102d · This submission: 109d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LIP Enzyme Linked Immunoabsorption Assay, 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 - LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum

All 18
Devices cleared under the same product code (LIP) and FDA review panel - the closest regulatory comparables to K241427.
VITROS Immunodiagnostic Products Syphilis Reagent Pack
K241534 · Ortho-Clinical Diagnostics · Aug 2024
Elecsys Syphilis
K211302 · Roche Diagnostics · Jul 2021
BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control Set
K170413 · Bio-Rad Laboratories · May 2017
Elecsys Syphilis
K160910 · Roche Diagnostics · Jul 2016
Lumipulse G TP-N Immunoreaction Cartridge Set
K153145 · Fujirebio Diagnostics,Inc. · Jul 2016
ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control
K153730 · Abbott Laboratories · Jun 2016