(40 days)
Not Found
No
The description focuses on the culture medium and detection system, with no mention of AI or ML in the device description, intended use, or performance studies.
No.
The device is used for the recovery and detection of mycobacteria from specimens, which is a diagnostic purpose, not a therapeutic one.
Yes
The device is designed for the recovery and detection of mycobacteria from clinical specimens, which are used to diagnose infections.
No
The device description clearly states it is a "culture bottle" and is used in conjunction with "detection instruments," indicating it is a physical component (a bottle) and relies on hardware for its function. It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "recovery and detection of mycobacteria from sterile body specimens other than blood, and from digested-decontaminated clinical specimens." This involves testing samples taken from the human body in vitro (outside the body) to diagnose or detect a condition (presence of mycobacteria).
- Device Description: The description further clarifies that it's 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." The phrase "in vitro culture recovery" is a key indicator of an IVD.
- Function: The device is used to grow and detect microorganisms in patient samples, which is a fundamental function of many IVD devices used in clinical laboratories.
The information provided clearly aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
MDB
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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.
Summary of Performance Studies
Study type: Non-clinical tests.
Sample size: 12 organisms.
Key results: 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.
Key Metrics
Not Found
Predicate Device(s)
BacT/ALERT MP Glass Process Bottle (K993576)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.2560 Microbial growth monitor.
(a)
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.(b)
Classification. Class I. With the exception of automated blood culturing system devices that are used in testing for bacteria, fungi, and other microorganisms in blood and other normally sterile body fluids, this device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.
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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, |
| 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
1
(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
PLASTIC CULTURE
BOTTLE | BACT/ALERT MP
GLASS PROCESS
BOTTLE (K993576) |
|-----------------------------------------|------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| Intended Use | Same | Same |
| Culture Bottle
Material | Plastic | Glass |
| Product Code | MDB | MDB |
| Technology | Reflectance | Reflectance |
| Color change based on
CO2 production | Yes | Yes |
| Sensor | Emulsion | Emulsion |
| Indicator Material | Xylenol Blue in
Silicone Emulsion | Xylenol Blue in
Silicone Emulsion |
| Growth of
microorganisms | Same | Same |
| Instrument Used | MB/BacT
Mycobacterial
Detection System and
BacT/ALERT 3D
Systems | MB/BacT
Mycobacterial
Detection System and
BacT/ALERT 3D
Systems |
| Sample source | Body fluids and
digested-
decontaminated clinical
specimens | Body fluids and
digested-
decontaminated clinical
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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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a circular arrangement of the words "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A." surrounding a stylized symbol. The symbol is composed of three curved lines that resemble a human figure with outstretched arms.
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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Page 2 -
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 (301) 594-3084. 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 (800) 638-2041 or (301) 443-6597 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
5
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