STARSWAB CULTURE COLLECTION AND TRANSPORT SYSTEM

K960997 · Starplex Scientific, Inc. · LIO · Apr 3, 1996 · Microbiology

Device Facts

• Record ID: K960997
• Device Name: STARSWAB CULTURE COLLECTION AND TRANSPORT SYSTEM
• Applicant: Starplex Scientific, Inc.
• Product Code: LIO · Microbiology
• Decision Date: Apr 3, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.2900
• Device Class: Class 1

Intended Use

The Starswab Culture Collection and Transport System is self-contained, sterile and intended for maintaining the viability of clinical specimens during transportation to the laboratory.

Device Story

Self-contained, sterile specimen collection and transport system; utilizes medium containing sodium thioglycollate as reducing agent; maintains moisture and media depth to support survival of aerobic and anaerobic microorganisms during transport to laboratory; used by clinical staff for specimen collection; ensures viability of microorganisms for subsequent laboratory culture and analysis; benefits patient by preserving specimen integrity for accurate diagnostic testing.

Clinical Evidence

Bench testing only. Comparative study of Starswab vs. Difco transport media using known inocula of ATCC type cultures and clinically significant microorganisms. Samples stored at room temperature for 24 and 48 hours, then subcultured to assess growth characteristics. Results demonstrated equivalent recovery between subject and predicate devices.

Technological Characteristics

Sterile, self-contained transport system. Medium contains sodium thioglycollate as a reducing agent. Designed for aerobic and anaerobic microorganism survival via moisture and media depth control.

Indications for Use

Indicated for the collection and transport of clinical specimens to maintain the viability of aerobic and anaerobic microorganisms.

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.

Predicate Devices

• Amies CultureSwab™ Transport Systems (Difco Laboratories)

Submission Summary (Full Text)

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K960997

# SUMMARY OF SAFETY AND EFFECTIVENESS

## 1. CONTACT NAME AND ADDRESS

APR - 3 1996

MEHDI KARAMCHI
50 STEINWAY BLVD.
ETOBICOKE, ONTARIO, CANADA
M9W 6Y3

TELEPHONE: [phone]

## 2. DEVICE NAME

Classification Name: Transport System, Aerobic/Anaerobic
Common Name: Sterile Microbiological Specimen Collection and Transport System
Proprietary Name: Starswab Culture Collection and Transport System

## 3. PREDICATE DEVICE

Amies CultureSwab™ Transport Systems with and without charcoal are marketed by Difco Laboratories, P.O. Box 331058, Detroit MI, 48232-7058, U.S.A.

## 4. DEVICE DESCRIPTION

The Starswab Culture Collection and Transport System is self-contained, sterile and intended for maintaining the viability of clinical specimens during transportation to the laboratory. The medium contains sodium thioglycollate as a reducing agent and the moisture and media depth provide an ideal environment for the survival of both aerobic and anaerobic microorganisms.

## 5. SUBSTANTIAL EQUIVALENCE DETERMINATION

The Starswab Culture Collection and Transport System is similar in design, manufacturing and intended usage to Amies Medium and Amies Medium without charcoal currently manufactured and marketed by Difco Laboratories. This substantial equivalence claim is supported by manufacturing, medium formulation, packaging and clinical evaluations. Known inocula of ATCC type cultures and clinically significant microorganisms were inoculated in the Starswab and Difco transport media and stored at room temperature for 24 and 48 hours prior to subculturing onto an appropriate culture media then checked for growth characteristics. No significant differences in recovery were detected between samples obtained from Starswab vs. Difco transport medium and the results were judged to be equivalent.