(64 days)
BacT/Alert Standard Aerobic Culture Bottle
Not Found
No
The summary describes a culture bottle and a microbial detection system that monitors for microbial growth. There is no mention of AI, ML, or any computational analysis of data beyond simple detection of growth. The performance studies focus on organism recovery and detection time, not on algorithmic performance.
No
The device is used to detect microorganisms in blood and body fluids, which is a diagnostic purpose, not a therapeutic one.
Yes
The device is used for the "recovery and detection of aerobic microorganisms (bacteria and fungi) from blood and other normally sterile body fluids," which is a diagnostic purpose to identify the presence of pathogens.
No
The device description clearly states it is a "Culture Bottle" and is used with "BacT/ALERT Microbial Detection Instruments," indicating it is a physical component (a bottle) and interacts with hardware (the instruments). It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used for "qualitative procedures for the recovery and detection of aerobic microorganisms (bacteria and fungi) from blood and other normally sterile body fluids." This involves testing samples taken from the human body in vitro (outside the body) to provide information about a person's health status (in this case, the presence of microorganisms indicating infection).
- Device Description: The description further reinforces this by explaining that the bottle provides conditions for organisms encountered in "blood infections and normally sterile body fluids," and that it is used with a system that monitors for the presence of microorganisms.
- Anatomical Site: The specified anatomical site is "Blood and other normally sterile body fluids," which are biological samples taken from the body for diagnostic purposes.
These points align directly with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / Indications for Use
The BacT/ALERT SA Culture Bottles are used with the BacT/ALERT Microbial Detection Systems in qualitative procedures for enhanced recovery and detection of aerobic microorganisms ( bacteria and fungi) from blood and other normally sterile body fluids.
BacT/ALERT SA Culture Bottles are used with the BacT/ALERT Microbial Detection Systems in qualitative procedures for the recovery and detection of aerobic microorganisms (bacteria and fungi) from blood and other normally sterile body fluids.
Product codes
MDB
Device Description
The BacT/ALERT SA Culture Bottle was developed for the same intended use as the current BacT/Alert Standard Aerobic Culture Bottle, to provide suitable nutritional and environmental conditions for organisms commonly encountered in blood infections and normally sterile body fluids. An inoculated bottle is placed into the BacT/ALERT Microbial Detection Instruments where it is incubated and continuously monitored for the presence of microorganisms that will grow in the BacT/ALERT SA 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 23 organisms diluted in human blood and inoculated into the BacT/ALERT SA bottle and the BacT/Alert Standard Aerobic bottle.
Summary of Performance Studies
The BacT/ALERT SA culture bottle was substantially equivalent to the BacT/Alert Standard Culture Bottle based on recovery of low levels of the 23 microorganisms included in the study. Detection times were equivalent in both bottles.
Key Metrics
Not Found
Predicate Device(s)
BacT/Alert Standard Aerobic Culture Bottle
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.
0
DEC I 5 1999
510(k) Premarket Notification Organon Teknika Corporation BacT/ALERT SA Culture Bottle
510(k) Summary
- 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 Submitter's Telephone: (919) 620-2288
Submitter's Contact: Rebecca A. Rivas
Date 510(k) Summary Prepared:
- The name of the device, including the trade or proprietary name if applicable, the common (a)(2) or usual name, and the classification name, if known;
Trade or Proprietary Name: BacT/ALERT SA Culture Bottle
Common or Usual Name: BacT/ALERT SA Culture Bottle
Classification Name: Microbial Growth Monitor
-
An identification of the legally marketed device to which the submitter claims substantial (a)(3) equivalence;
Device Equivalent to: BacT/Alert Standard Aerobic Culture Bottle -
A description of the device. (a)(4)
Device Description: The BacT/ALERT SA Culture Bottle was developed for the same intended use as the current BacT/Alert Standard Aerobic Culture Bottle, to provide suitable nutritional and environmental conditions for organisms commonly encountered in blood infections and normally sterile body fluids. An inoculated bottle is placed into the BacT/ALERT Microbial Detection Instruments where it is incubated and continuously monitored for the presence of microorganisms that will grow in the BacT/ALERT SA Bottle.
(a)(5) A statement of the intended use of the device.
Device Intended Use: The BacT/ALERT SA Culture Bottles are used with the BacT/ALERT Microbial Detection Systems in qualitative procedures for enhanced recovery and detection of aerobic microorganisms ( bacteria and fungi) from blood and other normally sterile body fluids.
1
510(k) Premarket Notification Organon Teknika Corporation BacT/ALERT SA Culture Bottle
- l
- A summary of the technological characteristics of the new device in comparison to those of (a)(6) the predicate device.
The BacT/ALERT SA Culture Bottle utilizes the same detection technology as the BacT/ALERT Standard Aerobic Culture Bottle.
| FEATURES | BACT/ALERT SA CULTURE BOTTLE | BACT/ALERT STANDARD
AEROBIC CULTURE
BOTTLE |
|-----------------------------------------|-----------------------------------------------|--------------------------------------------------|
| Technology | Reflectance | Reflectance |
| Color change based on
CO2 production | YES | YES |
| Sensor | Emulsion | Disc |
| Indicator material | Yes, Same as Standard Aerobic
Bottle | Yes |
| Growth of
microorganisms | Yes, Equivalent to Standard
Aerobic Bottle | Yes |
| Instrument Used | BacT/ALERT Microbial Detection Systems | BacT/ALERT Microbial
Detection Systems |
| Sample Source | Blood, Body Fluids | Blood, Body Fluids |
| Target Population | Adult | Adult |
2
510(k) Premarket Notification Organon Teknika Corporation BacT/ALERT SA 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:
Seeded studies were performed on 23 organisms diluted in human blood and inoculated into the BacT/ALERT SA bottle and the BacT/Alert Standard Aerobic bottle.
The conclusions drawn from the nonclinical and clinical tests that demonstrate that the (b)3) device is as safe, as effective, and performed as well or better than the legally marketed device identified in (a)(3).
The BacT/ALERT SA culture bottle was substantially equivalent to the BacT/Alert Standard Culture Bottle based on recovery of low levels of the 23 microorganisms included in the study. Detection times were equivalent in both bottles.
3
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of a human face in profile, with three wavy lines representing the hair and neck. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Public Health Service
DEC 1 5 1999
Food and Drug Administration 1390 Piccard Drive Rockville, MD 20850
Ms. Rebecca A. Rivas Regulatory Affairs Administrator Organon Teknika Corporation 100 Akzo Avenue Durham, North Carolina 27712
K993423 Re: Trade Name: BacT/ALERT SA Culture Bottle Regulatory Class: I Product Code: MDB Dated: October 11, 1999 Received: October 12, 1999
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 (OS) 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.
4
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 (770)488-7655.
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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Butman
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
5
j
510(k) Number (If known): _1993423
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
BacT/ALERT SA Culture Bottles are used with the BacT/ALERT Microbial Detection Systems in qualitative procedures for the recovery and detection of aerobic microorganisms (bacteria and fungi) from blood and other normally sterile body fluids.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) |
|---|
| --------------------- |
Division of Clinical Laboratory Devices
| 510(k) Number | K993423 |
|---|---|
| --------------- | --------- |
| Prescription Use | X |
|---|---|
| ------------------ | --- |
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Prescription Use (Per 21 CFR 801.109)