Cleared Traditional

K955143 - RPR LIQUID CONTROLS

K955143 is an FDA 510(k) clearance for RPR LIQUID CONTROLS, manufactured by Remel, L.P.. The device is a Class 2 Microbiology device with product code GMP cleared through the Traditional 510(k) pathway after a 260-day FDA review.

K955143 · Remel, L.P. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1996
Decision
260d
Days
Class 2
Risk

K955143 is an FDA 510(k) clearance for the RPR LIQUID CONTROLS. Classified as Antisera, Control For Nontreponemal Tests (product code GMP), Class II - Special Controls.

Submitted by Remel, L.P. (Augusta, US). The FDA issued a Cleared decision on July 30, 1996 after a review of 260 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3820 - 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 Remel, L.P. devices

FDA 510(k) Submission Details - K955143

510(k) Number K955143 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1995
Decision Date July 30, 1996
Days to Decision 260 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
158d slower than avg
Panel avg: 102d · This submission: 260d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GMP Device Classification - Class 2, Special Controls

Product Code GMP Antisera, Control For Nontreponemal Tests
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3820
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.