← Product Code [JSM](/productcode/JSM) · K032246

# MODIFICATION TO MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM (K032246)

_Starplex Scientific, Inc. · JSM · Aug 13, 2003 · Microbiology · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K032246

## Device Facts

- **Applicant:** Starplex Scientific, Inc.
- **Product Code:** [JSM](/productcode/JSM.md)
- **Decision Date:** Aug 13, 2003
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 866.2390
- **Device Class:** Class 1
- **Review Panel:** Microbiology

## Indications for Use

Multitrans is intended for the collection and transportation of viruses, chlamydia and mycoplasmas obtained from clinical specimens.

## Device Story

Starswab Multitrans is a sterile swab-based system for collecting and transporting clinical specimens. It utilizes an osmotically balanced buffered medium containing antibiotics to inhibit competing bacteria/yeast and serum albumin for stabilization. High sucrose concentration supports viral/chlamydia preservation during frozen storage (-70°C). Used by clinicians to maintain specimen viability during transit to laboratories. The device facilitates safe, leak-proof transport. This specific notification updates the recommended pre-use storage conditions from 2-8°C to 2-25°C.

## Clinical Evidence

Clinical evaluation conducted by the Ontario Provincial Public Health Laboratory to validate product performance under the updated storage temperature range (2-25°C). Results confirmed that performance characteristics are not compromised.

## Technological Characteristics

Sterile swab collection and transport system. Medium: osmotically balanced buffer, antibiotics, serum albumin, and high-concentration sucrose. Form factor: swab and transport tube. Storage condition: 2-25°C.

## Regulatory Identification

A transport culture medium is a device that consists of a semisolid, usually non-nutrient, medium that maintains the viability of suspected pathogens contained in patient specimens while in transit from the specimen collection area to the laboratory. The device aids in the diagnosis of disease caused by pathogenic microorganisms and also provides epidemiological information on these diseases.

## Predicate Devices

- Starswab Multitrans Collection and Transport System (k962843)

## Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

OIVD Review Memorandum

To: THE FILE

RE: DOCUMENT NUMBER K032246

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, device requiring 510(k). The following items are present and acceptable (delete/add items as necessary):

1. The name and 510(k) number of the SUBMITTER'S previously cleared device.
Starswab Multitrans Collection and Transport System, k962843

2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials.

3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was for

Storage conditions of the device changed from 2-8°C to 2-25°C

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics has been provided.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied
c) A declaration of conformity with design controls. The declaration of conformity should include:

i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and
ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosed

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis. The device is determined substantially equivalent to the previously cleared device.

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**Source:** [https://fda-staging.innolitics.com/device/K032246](https://fda-staging.innolitics.com/device/K032246)

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