Cleared Traditional

K964315 - REMEL STAPH LATEX KIT

K964315 is an FDA 510(k) clearance for REMEL STAPH LATEX KIT, manufactured by Remel, L.P.. The device is a Class 1 Microbiology device with product code JWX cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K964315 · Remel, L.P. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
101d
Days
Class 1
Risk

K964315 is an FDA 510(k) clearance for the REMEL STAPH LATEX KIT. Classified as Kit, Screening, Staphylococcus Aureus (product code JWX), Class I - General Controls.

Submitted by Remel, L.P. (Augusta, US). The FDA issued a Cleared decision on February 7, 1997 after a review of 101 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2660 - 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 - K964315

510(k) Number K964315 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 1996
Decision Date February 07, 1997
Days to Decision 101 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
1d faster than avg
Panel avg: 102d · This submission: 101d
Pathway characteristics
Predicate-based equivalence.

JWX Device Classification - Class 1, General Controls

Product Code JWX Kit, Screening, Staphylococcus Aureus
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JWX Kit, Screening, Staphylococcus Aureus

All 12
Devices cleared under the same product code (JWX) and FDA review panel - the closest regulatory comparables to K964315.
BINAXNOX STAPHYLOCOCCUS AUREUS TEST
K090964 · Binax, Inc. · Dec 2009
STAPHYTECT PLUS/DRYSPOT STAPHYTECT PLUS
K972030 · Oxoid , Ltd. · Sep 1997
STAPH-A-LEX(TM) SYSTEM
K926173 · Trinity Laboratories, Inc. · Aug 1993
SLIDEX STAPH-KIT
K923212 · Biomerieux Vitek, Inc. · Sep 1992
AXIOM TOTAL KNEE SYSTEM, TIBIAL COMPONENT
K902259 · Orthomet, Inc. · Jun 1990
NEG COMBO BREAKPOINT PANEL POS COMBO
K854278 · American Micro Scan · Mar 1986