COPAN MSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM

K121039 · Copan Flock Technologies · JTW · May 25, 2012 · Microbiology

Device Facts

• Record ID: K121039
• Device Name: COPAN MSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM
• Applicant: Copan Flock Technologies
• Product Code: JTW · Microbiology
• Decision Date: May 25, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.2900
• Device Class: Class 1

Indications for Use

MSwab is a Collection, Transport and Preservation System intended for the collection and transport of clinical specimens containing Gram positive aerobic and facultative anaerobic bacteria, HSV 1 and HSV 2 from the collection site to the testing laboratory. In the laboratory, MSwab specimens are processed using standard clinical laboratory operating procedures for culture.

Device Story

The Copan MSwab system consists of a plastic screw-cap tube containing 1 ml or 1.6 ml of transport medium (TRIS HCl, EDTA, TRIS Base, DMSO, Bovine Serum Albumin) and an optional nylon flocked swab. It is used by clinicians to collect clinical specimens (bacteria/viruses) and transport them to a laboratory. The device maintains the viability of Gram-positive aerobic/facultative anaerobic bacteria and HSV 1/2 during transit. In the laboratory, specimens are processed via standard culture procedures. The system benefits patients by ensuring specimen integrity and viability for accurate diagnostic testing.

Clinical Evidence

No clinical data. Bench testing only. Recovery studies demonstrated viability of various Gram-positive aerobic/facultative anaerobic bacteria and HSV 1/2 strains for at least 48 hours at 4-8°C and 20-25°C, and 14 days at -70°C. Stability testing confirmed viability and pH maintenance for up to 13 months post-manufacture.

Technological Characteristics

System includes plastic conical-bottom tubes and nylon flocked swabs. Medium contains TRIS HCl, EDTA, TRIS Base, DMSO, and Bovine Serum Albumin. Sterilization: Gamma irradiation for tubes (ISO 11137:2006); ETO for swabs (ISO 11135:2007). Biocompatibility tested per ISO 10993.

Indications for Use

Indicated for the collection and transport of clinical specimens containing Gram positive aerobic and facultative anaerobic bacteria, HSV 1, and HSV 2 from the collection site to the testing laboratory for culture-based processing.

Regulatory Classification

Identification

A microbiological specimen collection and transport device is a specimen collecting chamber intended for medical purposes to preserve the viability or integrity of microorganisms in specimens during storage of specimens after their collection and during their transport from the collecting area to the laboratory. The device may be labeled or otherwise represented as sterile. The device aids in the diagnosis of disease caused by pathogenic microorganisms.

Submission Summary (Full Text)

{0}

Statement for the Record, K 121039

This 510(k) was reviewed under OIVD’s Pilot Triage Program. This program represents an internal workload management tool intended to reduce internal FDA review resources for 510(k) applications that are of good quality upon receipt by FDA.

The information in the 510(k) is complete and supports a substantial equivalence (SE) determination. Please refer to the applicant’s 510(k) summary for a summary of the information that supports this SE determination.