MB/BACT BLOOD CULTURE BOTTLE

K982263 · Organon Teknika Corp. · MDB · Aug 18, 1998 · Microbiology

Device Facts

• Record ID: K982263
• Device Name: MB/BACT BLOOD CULTURE BOTTLE
• Applicant: Organon Teknika Corp.
• Product Code: MDB · Microbiology
• Decision Date: Aug 18, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.2560
• Device Class: Class 1

Intended Use

MB/BacT Blood Culture Bottles in combination with the MB/BacT Enrichment Fluid are specifically designed for the cultivation of Mycobacterium sp. commonly isolated from blood when used in conjunction with the MB/BacT Mycobacterial Detection System.

Device Story

MB/BacT Blood Culture Bottle is an in-vitro diagnostic device for cultivating and detecting Mycobacterium species in blood. The system utilizes a colorimetric sensor to monitor CO2 production resulting from microbial metabolism within the culture media; reflectance values are measured to detect growth. The device consists of a culture bottle and enrichment fluid. It is intended for use in clinical laboratory settings by trained personnel. By providing a non-radiometric alternative to traditional methods, it facilitates the identification of mycobacterial infections, aiding clinicians in diagnosis and treatment decisions.

Clinical Evidence

Two clinical studies compared the MB/BacT Blood Culture Bottle to the BACTEC 13A using 238 paired blood samples (5 ml each). Results showed 55 organisms isolated by both systems, 9 isolated by MB/BacT only, and 2 isolated by BACTEC 13A only. Non-clinical testing evaluated 20 mycobacterial isolates across 10 species at two inoculum levels (1x10^1 and 1x10^2 CFU) under non-shaking conditions, demonstrating favorable growth performance.

Technological Characteristics

In-vitro diagnostic microbial growth monitor. Uses colorimetric sensor technology to measure CO2 production via reflectance values. Components include culture bottle and enrichment fluid. Storage requirements: 15°C-30°C for bottles, 2°C-8°C for enrichment fluid. Non-radiometric detection principle.

Indications for Use

Indicated for the cultivation and detection of Mycobacterium species from blood samples in patients suspected of mycobacterial infection.

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

• BACTEC 13A Blood Bottle (K863191)

Submission Summary (Full Text)

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KC982263

AUG 1 8 1998

## 510(k) Premarket Notification Organon Teknika Corporation MB/BacT™ Blood Culture Bottle

#### 510(K) SUMMARY 17.0

A 510(k) Summary follows for the MB/BacT™ Blood Culture Bottle product described in this submission.

.00137

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## 510(k) Premarket Notification Organon Teknika Corporation MB/BacT™ Blood Culture Bottle

## 510(k) Summary MDA™Simplastin HTF

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

Submitter's Name: Organon Teknika Corporation

Submitter's Address: 100 Akzo Avenue, Durham, North Carolina, 27712 USA

Submitter's Telephone: [phone]

Submitter's Contact: Rebecca Rivas

Date 510(k) Summary Prepared:

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

Trade or Proprietary Name: MB/BacT™ Blood Culture Bottle

Common or Usual Name: Mycobacterium Blood Culture Bottle

Classification Name: Microbial Growth Monitor

- An identification of the legally marketed device to which the submitter claims (a)(3) substantial equivalence;
BACTEC 13A Blood Bottle - Becton Dickinson & Device Equivalent to: Co.(K863191)

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

Device Description: MB/BacT Blood Culture Bottles are specifically designed forthe cultivation of Mycobacterium sp. Commonly isolated from blood.

- (a)(5) A statement of the intended use of the device.
Device Intended Use: Recovery and detection of Mycobacteria from blood.

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## 510(k) Premarket Notification Organon Teknika Corporation MB/BacT™ Blood Culture Bottle

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

| Assay Feature | MB/BacT™ Blood Culture Bottle | BACTEC 13A Blood Culture<br>Bottle |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Specimen Source | Blood | Blood |
| Intended Use | Culture and detection of Mycobacteria sp.<br>from blood. | Culture and detection of<br>microorganisms (mainly<br>Mycobacteria) from blood. |
| Sample Volume | 5 mls. | 5 mls. |
| Technology | Colorimetric sensor and reflectance<br>values are used to monitor production<br>of CO₂ dissolved in culture media. | Radiometric technique, 14CO₂<br>produced by Mycobacteria from<br>the metabolism of 14C-labeled<br>substance is measured. |
| Storage | Culture Bottles - 15°C - 30°C | Culture Bottles - 2°C - 25°C |
| | Enrichment Fluid - 2°C - 8°C | Enrichment Fluid - 2° - 25°C |
| Components | Culture Bottle and Enrichment Fluid | Culture Bottle and Enrichment<br>Fluid |
| Controls | Certificate of Analysis provided, lab<br>may test new lots if desired with<br>ATCC#25291 and ATCC#13950<br>recommended days to positive provided<br>in package insert. | Quality Control Certificates provided. |

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## 510(k) Premarket Notification Organon Teknika Corporation MB/BacT™ Blood Culture Bottle

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

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

A total of twenty mycobacterial isolates were tested representing ten different species. All isolates were evaluated in non-shaking conditions for two theoretical levels of inocula, 1 x 102 and 1 x 101 CFU, respectively. Overall, favorable growth performance was achieved with the cultures.

#### A brief discussion of the clinical tests submitted, referenced, or relied on in the (b)(2) premarket notification submission for a determination of substantial equivalency.

Two clinical studies were carried out with a total of 238 paired bottles. Blood was inoculated in even volumes of 5 mls. into each bottle pair. The studies compared growth of Mycobacteria sp. from blood between the MB/BacT Blood Culture Bottles and the BacTec 13A Culture Bottle. Out of the 238 paired bottles, 55 organisms were isolated by both bottles. 9 organisms were isolated by MB/BacT bottles only and 2 organisms were isolated by BacTec 13A bottles only.

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

Both the MB/BacT Blood Culture Bottle and the predicate device, the BacTec 13A are equivalent in the following respects:

- They have the same intended use: the recovery and detection of Mycobacteria in 1. blood.
- 2. They are both in-vitro diagnostic test systems which are based on microbial growth in media.
- Organon Teknika's MB/BacT Blood Culture Bottle yield test results, both in clinical 3. studies and in-house studies, comparable to that seen with the predicate device the BacTec 13A Blood Culture Bottle.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

### Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

# AUG 1 8 1998

Rebecca A. Rivas Regulatory Affairs Administrator Organon Teknika Corporation 100 Akzo Avenue Durham, N.C. 27712

Re: K982263

> Trade Name: MB/BACT® Blood Culture Bottle Regulatory Class: I Product Code: MDB Dated: June 25, 1998 Received: June 29, 1998

Dear Ms. Rivas:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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## Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number [phone] or at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours.

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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(10(k) Number (If known):

MB/BacT Blood Culture Bottle Device Name:

Indications For Use:

MB/BacT Blood Culture Bottles in combination with the MB/BacT Enrichment Fluid are specifically designed for the cultivation of Mycobacterium sp. commonly isolated from blood when used in conjunction with the MB/BacT Mycobacterial Detection System.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Woody Dubois

(Division Sign-off)
Division of Clinical Laboratory Devices
510(k) Number K982263

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

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