(46 days)
BacT/ALERT Pedi-BacT Culture Bottle
Not Found
No
The summary describes a microbial detection system based on incubation and continuous monitoring, with no mention of AI or ML technologies.
No
The device is used for detection of microorganisms in blood samples, which is a diagnostic purpose, not a therapeutic one. It identifies the presence of microorganisms but does not treat any condition.
Yes.
The device is used for the "detection of aerobic and facultative anaerobic microorganisms (bacteria and yeast) from blood," indicating its role in identifying the presence of pathogens to aid in diagnosis.
No
The device description clearly states it is a "Culture Bottle" and is placed "into the instrument," indicating it is a physical component (hardware) used in conjunction with a microbial detection system.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the BacT/ALERT PF Culture Bottles are used in "qualitative procedures for enhanced recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria and yeast) from blood." This describes a test performed on a sample taken from the human body (blood) to provide information about a person's health status (presence of microorganisms).
- Device Description: The description further clarifies that the device is used to "detect microorganisms" in an inoculated blood sample. This is a diagnostic process.
- Sample Type: The device is used with "blood," which is a biological sample taken from a patient.
- Purpose: The purpose is to "detect microorganisms," which is a diagnostic activity aimed at identifying the cause of a potential infection.
These characteristics align 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 PF Culture Bottles are used with the BacT/ALERT Microbial Detection Systems in qualitative procedures for enhanced recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria and yeast) from blood.
Product codes
MDB
Device Description
The BacT/ALERT PF Culture Bottle provides a sensitive Device Description: method for detection of microorganisms when only a small volume of blood is available. An inoculated bottle is placed into the instrument where it is incubated and continuously monitored for the presence of microorganisms that will grow in the BacT/ALERT PF Culture 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
Not Found
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
Not Found
Summary of Performance Studies
In-house seeded studies were performed utilizing 23 organisms seeded into BacT/ALERT PF and Pedi-BacT Culture Bottles. Two concentrations of organisms were seeded one at
§ 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
510(k) Premarket Notification Organon Teknika Corporation BacT/ALERT PF Culture Bottle 510(k) Summary
The submitter's name, address, telephone number, a contact person, and the date (a)(1) the 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:
- (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 PF Culture Bottle
Common or Usual Name: BacT/ALERT PF Culture Bottle
Classification Name: Microbial Growth Monitor
An identification of the legally marketed device to which the submitter claims (a)(3) substantial equivalence:
Device Equivalent to: BacT/ALERT Pedi-BacT Culture Bottle
(a)(4) A description of the device.
The BacT/ALERT PF Culture Bottle provides a sensitive Device Description: method for detection of microorganisms when only a small volume of blood is available. An inoculated bottle is placed into the instrument where it is incubated and continuously monitored for the presence of microorganisms that will grow in the BacT/ALERT PF Culture Bottle.
(a)(5) A statement of the intended use of the device.
Device Intended Use: The BacT/ALERT PF Culture Bottles are used with the BacT/ALERT Microbial Detection Systems in qualitative procedures for enhanced recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria and yeast) from blood.
1
510(k) Premarket Notification Organon Teknika Corporation BacT/ALERT PF Culture Bottle
A summary of the technological characteristics of the new device in comparison to (a)(6) those of the predicate device.
The BacT/ALERT PF Culture Bottle utilizes the same detection technology as the BacT/Alert Pedi-BacT Culture Bottle.
| FEATURES | BACT/ALERT PF CULTURE BOTTLE | BACT/ALERT PEDI-BACT CULTURE BOTTLE |
|---|---|---|
| Technology | Reflectance | Reflectance |
| Color change based on CO2 production | YES | YES |
| Sensor | Emulsion | Disc |
| Indicator material | Yes, Same as Pedi-BacT Bottle | Yes |
| Growth of microorganisms | Yes, Equivalent to Pedi-BacT Bottle | Yes |
| Instrument Used | BacT/ALERT Microbial Detection Systems | BacT/ALERT Microbial Detection Systems |
| Sample Source | Blood | Blood |
| Target Population | Pediatric | Pediatric |
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:
In-house seeded studies were performed utilizing 23 organisms seeded into BacT/ALERT PF and Pedi-BacT Culture Bottles. Two concentrations of organisms were seeded one at