BACT/ALERT MP CULTURE BOTTLES (PLASTIC)

K031737 · bioMerieux, Inc. · MDB · Jul 14, 2003 · Microbiology

Device Facts

• Record ID: K031737
• Device Name: BACT/ALERT MP CULTURE BOTTLES (PLASTIC)
• Applicant: bioMerieux, Inc.
• Product Code: MDB · Microbiology
• Decision Date: Jul 14, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.2560
• Device Class: Class 1

Indications for Use

The BacT/ALERT MP culture bottle is designed for use with the MB/BacT and the BacT/ALERT 3D Mycobacteria Detection Systems, for recovery and detection of mycobacteria from sterile body specimens other than blood, and from digested-decontaminated clinical specimens.

Device Story

BacT/ALERT MP culture bottle is a selective growth medium container for in vitro recovery of mycobacteria. Input: sterile body fluids or digested-decontaminated clinical specimens. Operation: inoculated bottle incubated in MB/BacT or BacT/ALERT 3D instrument; instrument continuously monitors for mycobacterial growth via reflectance technology; sensor (xylenol blue in silicone emulsion) detects CO2 production. Output: automated detection of mycobacterial presence. Used in clinical laboratories by technicians. Output informs healthcare providers of mycobacterial infection, facilitating clinical diagnosis and treatment decisions. Plastic bottle design replaces glass predicate to improve safety/handling while maintaining equivalent growth and detection performance.

Clinical Evidence

Bench testing only. Seeded studies performed on 12 mycobacterial organisms comparing the plastic culture bottle to the glass predicate. Results showed substantially equivalent recovery rates and detection times.

Technological Characteristics

Plastic culture bottle; reflectance-based detection technology; CO2-sensitive sensor using xylenol blue in silicone emulsion; compatible with MB/BacT and BacT/ALERT 3D systems; intended for adult clinical specimens.

Indications for Use

Indicated for adult patients requiring recovery and detection of mycobacteria from sterile body specimens (excluding blood) and digested-decontaminated clinical specimens using MB/BacT or BacT/ALERT 3D systems.

Regulatory Classification

Identification

A microbial growth monitor is a device intended for medical purposes that measures the concentration of bacteria suspended in a liquid medium by measuring changes in light scattering properties, optical density, electrical impedance, or by making direct bacterial counts. The device aids in the diagnosis of disease caused by pathogenic microorganisms.

Predicate Devices

• BacT/ALERT MP Glass Process Bottle (K993576)

Submission Summary (Full Text)

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Premarket Notific bioMerieux, Inc. BacT/ALERT MP Culture Bottles (plastic)

JUL 1 4 2003

# 510(k) Summary

#### (a)(1) The submitter's name, address, telephone number, a contact person, and the date the summary was prepared:

| Submitter's Name: | bioMérieux, Inc. |
|-------------------------------|------------------------------------------------------|
| Submitter's Address: | 100 Rodolphe Street,<br>Durham, North Carolina 27712 |
| Submitter's Telephone: | (919)-620-2968 |
| Submitter's Contact: | Jocelyn Jennings, RAC |
| Date 510(k) Summary prepared: | May 29, 2003 |

- (a)(2) The name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known;

| Trade or Proprietary Name: | BacT/ALERT MP Culture Bottle |
|----------------------------|------------------------------|
| Common or Usual Name: | BacT/ALERT MP Culture Bottle |
| Classification Name: | Microbial Growth Monitor |

- (a)(3) An identification of the legally marketed device to which the submitter claims substantial equivalence;
Device Equivalent to: BacT/ALERT MP Glass Process Bottle

#### (a)(4) A description of the device

Device Description: The BacT/ALERT MP culture bottle was developed for the same intended use as the current BacT/ALERT MP Process Bottle (glass), when used in conjunction with the MB/BacT Reconstitution Fluid (for use with sterile specimens) or with MB BacT Antibiotic Supplement (for use with digesteddecontaminated clinical specimens) is a selective growth medium for the in vitro culture recovery of mycobacteria organisms commonly encountered in body fluids other than blood and from digested-decontaminated clinical specimens. An inoculated bottle is placed into the MB BacT Detection instrument or the BacT/ALERT 3D instrument where it is incubated and continuously monitored for the presence of mycobacteria that will grow in the BacT/ALERT MP bottle.

CONFIDENTIAL

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### (a)(5) A statement of the intended use of the device

Device Intended Use: The BacT/ALERT MP culture bottle is designed for use with the MB/BacT and the BacT/ALERT 3D Mycobacteria Detection Systems, for recovery and detection of mycobacteria from sterile body specimens other than blood, and from digested-decontaminated clinical specimens.

#### (a)(6) A summary of the technological characteristics of the new device in comparison to those of the predicate device

The BacT/ALERT MP Plastic Culture Bottle utilizes the same detection technology as the BacT/ALERT MP Glass Process Bottle. The similarities and/or differences with marketed device are listed in Table (a)(6) 1.

| FEATURES | BACT/ALERT MP<br>PLASTIC CULTURE<br>BOTTLE | BACT/ALERT MP<br>GLASS PROCESS<br>BOTTLE (K993576) |
|-----------------------------------------|------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| Intended Use | Same | Same |
| Culture Bottle<br>Material | Plastic | Glass |
| Product Code | MDB | MDB |
| Technology | Reflectance | Reflectance |
| Color change based on<br>CO2 production | Yes | Yes |
| Sensor | Emulsion | Emulsion |
| Indicator Material | Xylenol Blue in<br>Silicone Emulsion | Xylenol Blue in<br>Silicone Emulsion |
| Growth of<br>microorganisms | Same | Same |
| Instrument Used | MB/BacT<br>Mycobacterial<br>Detection System and<br>BacT/ALERT 3D<br>Systems | MB/BacT<br>Mycobacterial<br>Detection System and<br>BacT/ALERT 3D<br>Systems |
| Sample source | Body fluids and<br>digested-<br>decontaminated clinical<br>specimens | Body fluids and<br>digested-<br>decontaminated clinical<br>specimens |
| Target Population | Adult | Adult |

CONFIDENTIAL

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### (b)(1) A brief discussion of the nonclinical tests submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalency

Testing was performed to establish the performance characteristics of the new device including:

Seeded studies were performed on 12 organisms and inoculated into the BacT/ALERT MP Plastic Culture Bottle and the BacT/ALERT MP Glass Process Bottle.

## (b)(2) The conclusions drawn from the nonclinical and clinical tests that demonstrate that the device is as safe, as effective, and performed as well or better than the legally marketed device identified in (a)(3)

The BacT/ALERT MP Plastic Culture Bottle was substantially equivalent to the BacT/ALERT MP Glass Process Bottle based on recovery of the 12 mycobacterial organisms included in the study. Detection times were substantially equivalent in both bottles.

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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 1 4 2003

Jocelyn Jennings, RAC Senior Regulatory Affairs Specialist Biomerieux, Inc. 100 Rodolphe Street Durham, NC 27712

Re: k031737

> Trade/Device Name: BacT/ALERT MP Culture Bottle Regulation Number: 21 CFR 866.2560 Regulation Name: Microbial Growth Monitor Regulatory Class: Class I Product Code: MDB Dated: June 3, 2003 Received: June 9, 2003

Dear Ms. Jennings:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Putman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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#### INDICATIONS FOR USE STATEMENT VI.

510(k) Number (if known): K 031737

Device Name: BacT/ALERT MP Culture Bottle

Indications For Use:

The BacT/ALERT MP culture bottle is designed for use with the MB/BacT and the BacT/ALERT 3D Mycobacteria Detection Systems, for recovery and detection of mycobacteria from sterile body specimens other than blood, and from digested-decontaminated clinical specimens.

### (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Prescription Use V

Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Fuddie Mc. Poole

**Division Sign-Off**

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K03 1737

CONFIDENTIAL