(255 days)
BacT/ALERT® PF Culture Bottle (K020923)
No
The summary describes a culture bottle and a microbial detection system that uses a colorimetric sensor to detect CO2 production, indicating microbial growth. There is no mention of AI or ML in the device description, intended use, or performance studies. The system relies on a direct chemical/optical measurement, not algorithmic interpretation of complex data patterns.
No
The device is described as a diagnostic tool used to detect microorganisms in blood samples, not to treat a condition.
Yes
The device, the BacT/ALERT® Microbial Detection System with BacT/ALERT® PF Plus Culture Bottles, is used for the "recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria and yeast) from blood," which directly indicates its role in diagnosing infections by identifying microbial presence.
No
The device is a culture bottle, which is a physical reagent used with a hardware system (BacT/ALERT Microbial Detection System). It is not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the BacT/ALERT® PF Plus Culture Bottles are used "in qualitative procedures for 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 details a system that analyzes a biological sample (blood) to detect the presence of microorganisms. The system monitors changes in the culture medium due to microbial growth, which is a diagnostic process.
- Anatomical Site: The sample is taken from "Blood," which is a human biological specimen.
- Clinical Study Results: The inclusion of clinical study results comparing the device to a predicate device for detecting microorganisms in blood further supports its classification as a diagnostic tool used in a clinical setting.
The device is designed to be used in vitro (outside the body) to diagnose the presence of microorganisms in a patient's blood sample. This aligns directly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
BacT/ALERT® PF Plus Culture Bottles are used with the BacT/ALERT® Microbial Detection System in qualitative procedures for recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria and yeast) from blood.
Product codes
MDB
Device Description
The new reagent (BacT/ALERT PF Plus Culture Bottle) is an improvement upon the cleared charcoal formulation reagent (BacT/ALERT PF Culture Bottle). The BacT/ALERT PF Culture Bottles are used with the BacT/ALERT Microbial Detection Systems in qualitative procedures for recovery and detection of microorganisms from blood.
The predicate BacT/ALERT PF Culture Bottle contains charcoal, for its antimicrobial neutralization properties, in a complex growth medium. Charcoal is eliminated in the proposed BacT/ALERT PF Plus Culture Bottle, and is replaced with two types of adsorbent resins in a complex growth medium. The proposed BacT/ALERT PF Plus Culture Bottle is optimized to increase antimicrobial neutralization properties, and to increase the clarity of Gram stains in comparison to the predicate BacT/ALERT PF Culture Bottle.
The BacT/ALERT Microbial Detection System provides both a microbial detection system and a culture medium bottle with suitable nutritional and environmental conditions for microorganisms commonly encountered in blood (adult and pediatric bottles) or other normally sterile body fluid samples (except urine) (adult bottles only) taken from a patient suspected of having bacteremia/fungemia. 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 bottles.
The BacT/ALERT Microbial Detection System utilizes a colorimetric sensor and reflected light to monitor the presence and production of carbon dioxide (CO2) that is dissolved in the culture medium. If microorganisms are present in the test sample, carbon dioxide is produced as the microorganisms mefabolize the substrates in the culture medium. When growth of the microorganisms produces CO2, the color of the gas-permeable sensor installed in the bottom of each culture bottle changes from blue-green to yellow. The lighter color results in an increase of reflectance units monitored by the system. Bottle reflectance is monitored and recorded by the instrument every 10 minutes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Blood
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
Analytical Testing:
- Analytical Sensitivity: Growth Performance: Data represents results from in-house seeded studies with blood obtained from healthy human volunteers. Multiple strains were tested for each species at target inoculum levels of 125 CFU per bottle. The species listed are representatives of clinically prevalent organisms in blood cultures.
- Antimicrobial Neutralization: Internal studies demonstrated effective neutralization of antimicrobials by the BacT/ALERT PF Plus medium, except for ceftazidime and cefepime, and less than complete neutralization for cefotaxime and ceftriaxone.
- Potentially Interfering Substances: In-house seeded studies with plasma, blood, and blood clots (with and without white blood cells and microorganisms) showed no interference with recovery/detection or false positives.
- Limit of Detection (LoD): Data from in-house seeded studies, with a minimum of 30 replicates per species, using bottles at end of shelf life. At least 95% detection was achieved at LoD.
- Within-Laboratory Precision (Repeatability): Data represents results from in-house seeded studies conducted on 12 days on multiple instruments by multiple operators. Organisms were grown in the presence of clinically relevant concentrations of antimicrobials to which they are susceptible. A minimum of 108 replicates were tested for each organism/antimicrobial combination.
- Reproducibility: Seeded studies conducted at three sites using a target of 162 replicates per site on 3 days with a minimum of two operators per site. Reproducibility was evaluated on each of 9 organisms.
- Delayed Entry: Results from seeded studies using 11 species at target concentrations 100 CFU per bottle (acceptable range of 30 to 300 CFU per bottle) were generated at three sites. All bottles contained human blood from healthy volunteers and were held at specified temperatures and times prior to loading into the BacT/ALERT instrument.
Clinical Study Results (Blood Cultures):
A multi-center clinical study was conducted at three different geographic sites in the U.S. comparing the performance of the PF Plus and PF blood culture bottles for pediatric culture pairs. A total of 2188 bottle pairs were obtained from 1086 pediatric patients suspected of blood stream bacterial/yeast infections. Subcultures of both bottles were performed when either bottle in the set was determined to be positive by the BacT/ALERT system. A pair of bottles was determined to have a positive status if the subculture of either the PF Plus or PF bottle was positive. A culture bottle was determined to be a "True Positive" if the culture was flagged positive by the BacT/ALERT System and resulted in growth of the isolate upon subculture of this bottle. True positive rates were calculated for the PF Plus and PF culture bottles, and the ratio of PF Plus true positives to PF true positives was calculated to compare performance. Clinical isolates recovered were classified as significant, contaminant, or unknown based on determination by the clinical trial sites.
Total isolates recovered: 172.
Total compliant pairs with positive status: 145.
Total population reported: 2215 results (172 isolates + 2043 negative bottle pairs).
BacT/ALERT PF Plus detected 140 isolates.
BacT/ALERT PF detected 128 isolates.
Significant isolates detected by PF Plus: 91.
Significant isolates detected by PF: 77.
False positive with PF Plus: 1 (0.05% of study population).
Ratio of true positive rates for overall isolates: 1.094 (140/128) with a 95% CI of (0.954, 1.234).
Key Metrics
-
Analytical Sensitivity (% Recovery):
Staphylococcus aureus: 100.0% (30/30)
Escherichia coli: 100.0% (30/30)
Pseudomonas aeruginosa: 100.0% (12/12)
Klebsiella pneumoniae: 100.0% (12/12)
Candida albicans: 100.0% (30/30)
Streptococcus pneumoniae: 100.0% (30/30)
Staphylococcus epidermidis: 100.0% (12/12)
Enterococcus faecalis: 100.0% (12/12)
Enterococcus faecium: 100.0% (12/12)
Enterobacter cloacae: 100.0% (12/12)
Candida glabrata: 100.0% (12/12)
Haemophilus influenzae: 100.0% (12/12)
Proteus mirabilis: 100.0% (12/12) -
Limit of Detection (LoD) (CFU/bottle) for at least 95% detection:
Candida albicans: 6
Enterobacter aerogenes: 8
Enterococcus faecalis: 5
Escherichia coli: 4
Haemophilus influenzae: 6
Klebsiella pneumoniae: 4
Listeria monocytogenes: 6
Pseudomonas aeruginosa: 4
Salmonella enterica: 5
Staphylococcus aureus: 5
Streptococcus pneumoniae: 6 -
Within-Laboratory Precision (% Recovery):
C. albicans/Fluconazole: 100.0% (Overall)
E. coli/Amikacin: 100.0% (Overall)
K. pneumoniae/Levofloxacin: 100.0% (Overall)
P. aeruginosa/Piperacillin: 99.1% (Overall)
S. pneumoniae/Penicillin G: 100.0% (Overall)
S. aureus/Vancomycin: 100.0% (Overall) -
Reproducibility (% Recovery):
Overall: 92.0% (698/759) with 95% CI: 89.8%, 93.8% -
Delayed Entry (% Recovery):
Control (No delay): 100.0% (459/459)
2-8°C, 48h hold: 98.6% (292/296)
20-25°C, 24h hold: 98.0% (291/297)
20-25°C, 36h hold: 91.9% (272/296)
35-37°C, 8h hold: 98.9% (454/459)
35-37°C, 24h hold: 56.6% (259/458)
Negative Controls: 0.5% (1/221) False Positive -
Clinical Study Results (% of population of 2215 results):
BacT/ALERT PF Plus True Positives:
Significant: 4.1% (91/2215)
Contaminant: 1.1% (24/2215)
Unknown: 1.1% (25/2215)
Total: 6.3% (140/2215)
BacT/ALERT PF True Positives:
Significant: 3.5% (77/2215)
Contaminant: 1.3% (29/2215)
Unknown: 1.0% (22/2215)
Total: 5.8% (128/2215)
Ratio of True Positives (PF Plus / PF):
Significant: 1.182
Contaminant: 0.828
Unknown: 1.136
Total: 1.094
False positive for BacT/ALERT PF Plus: 0.05% (1/2215)
Predicate Device(s)
BacT/ALERT® PF Culture Bottle (K020923)
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
KI21446
510(k) SUMMARY
JAN 2 5 2013
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
Name of device
BacT/ALERT® PF Plus
Device Identification
Trade Name: BacT/ALERT® PF Plus Culture Bottle Classification Name: Blood Culturing System, Microbiology
Product Code: MDB
Regulation: 21CFR866.2560, microbial growth monitor
Device Class: Class 1, not exempt from premarket notification per 21CFR807.81
Premarket Notification Submitter
| Company Name: | bioMérieux, Inc. |
|---|---|
| Company Address: | 100 Rodolphe Street |
| Durham, NC 27712 | |
| Contact: | Elizabeth Landon, Staff Regulatory Affairs Specialist |
| Telephone #: | 919-620-2329 |
| FAX #: | 919-620-2548 |
| Alternate Contact: | Jocelyn Jennings, Senior Manager, Regulatory Affairs |
| Telephone #: | 919-620-2894 |
| FAX #: | 919-620-2548 |
| Preparation Date: | May 11, 2012 |
Intended Use of the Device
BacT/ALERT® PF Plus Culture Bottles are used with the BacT/ALERT® Microbial Detection System in qualitative procedures for recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria and yeast) from blood.
Description of the Device
The new reagent (BacT/ALERT PF Plus Culture Bottle) is an improvement upon the cleared charcoal formulation reagent (BacT/ALERT PF Culture Bottle). The BacT/ALERT PF Culture Bottles are used with the BacT/ALERT Microbial Detection Systems in qualitative procedures for recovery and detection of microorganisms from blood.
1
The predicate BacT/ALERT PF Culture Bottle contains charcoal, for its antimicrobial neutralization properties, in a complex growth medium. Charcoal is eliminated in the proposed BacT/ALERT PF Plus Culture Bottle, and is replaced with two types of adsorbent resins in a complex growth medium. The proposed BacT/ALERT PF Plus Culture Bottle is optimized to increase antimicrobial neutralization properties, and to increase the clarity of Gram stains in comparison to the predicate BacT/ALERT PF Culture Bottle.
The BacT/ALERT Microbial Detection System provides both a microbial detection system and a culture medium bottle with suitable nutritional and environmental conditions for microorganisms commonly encountered in blood (adult and pediatric bottles) or other normally sterile body fluid samples (except urine) (adult bottles only) taken from a patient suspected of having bacteremia/fungemia. 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 bottles.
The BacT/ALERT Microbial Detection System utilizes a colorimetric sensor and reflected light to monitor the presence and production of carbon dioxide (CO2) that is dissolved in the culture medium. If microorganisms are present in the test sample, carbon dioxide is produced as the microorganisms mefabolize the substrates in the culture medium. When growth of the microorganisms produces CO2, the color of the gas-permeable sensor installed in the bottom of each culture bottle changes from blue-green to yellow. The lighter color results in an increase of reflectance units monitored by the system. Bottle reflectance is monitored and recorded by the instrument every 10 minutes.
SUBSTANTIAL EQUIVALENCE INFORMATION
Predicate device name(s)
BacT/ALERT® PF Culture Bottle
Predicate device 510(k) number(s) K020923
Comparison with predicate
The BacT/ALERT PF Plus Culture Bottle is claimed substantially equivalent to the BacT/ALERT PF Culture Bottle (K020923).
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Image /page/2/Picture/0 description: The image shows the logo for BIOMÉRIEUX. The logo consists of the word "BIOMÉRIEUX" in a stylized font, with a circle above the text. A line extends vertically through the center of the circle and text.
| Table 1. Similarities and differences between the tests are outlined below: | ||
|---|---|---|
| -- | -- | ----------------------------------------------------------------------------- |
| Culture Bottle Characteristics: Changes versus K020923 | |
|---|---|
| Specimen Sampling and | |
| Handling | unchanged |
| Assay Types | unchanged |
| Reaction Types | unchanged |
| Calibration | unchanged |
| Quality Control (by Operator) | unchanged |
| Principles of Operation | unchanged |
| Firmware | No changes to firmware occurred. |
| The structure of the firmware algorithm remain unchanged. | |
| The knowledge base specifications utilized by the firmware included | |
| changes to the initial value threshold variables used by the firmware | |
| algorithm. | |
| Variables related to controlling barcode recognition were adjusted to | |
| enable recognition of the new bottle type. |
Performance Characteristics
Analytical Testing
Analytical Sensitivity: Growth Performance
Data represent results from in-house seeded studies with blood obtained from healthy human volunteers. Multiple strains were tested for each species at target inoculum levels of 125 CFU per bottle. The species listed are representatives of clinically prevalent organisms in blood cultures.
3
| Blood | ||||
|---|---|---|---|---|
| Microorganism | % Recovery (n) | Range CFU/bottle | Time to Detection (hours) Mean | Range |
| Staphylococcus aureus | 100.0 (30/30) | 54 - 150 | 13.3 | 12.2 - 15.2 |
| Escherichia coli | 100.0 (30/30) | 71 - 254 | 11.2 | 10.3 - 11.7 |
| Pseudomonas aeruginosa | 100.0 (12/12) | 74 - 148 | 15.7 | 13.7 - 17.8 |
| Klebsiella pneumoniae | 100.0 (12/12) | 89 - 123 | 11.3 | 10.6 - 12.3 |
| Candida albicans | 100.0 (30/30) | 88 - 298 | 29.0 | 19.2 - 52.8 |
| Streptococcus pneumoniae | 100.0 (30/30) | 3 - 260 | 13.8 | 10.8 - 16.5 |
| Staphylococcus epidermidis | 100.0 (12/12) | 44 - 135 | 17.6 | 14.3 - 18.8 |
| Enterococcus faecalis | 100.0 (12/12) | 63 - 259 | 11.6 | 11.0 - 12.2 |
| Enterococcus faecium | 100.0 (12/12) | 25 - 120 | 12.8 | 11.3 - 14.4 |
| Enterobacter cloacae . | 100.0 (12/12) | 111 - 200 | 11.6 | 10.8 - 12.5 |
| Candida glabrata | 100.0 (12/12) | 118 - 281 | 43.5 | 27.3 - 64.8 |
| Haemophilus influenzae | 100.0 (12/12) | 105 - 266 | 14.4 | 12.0 - 16.8 |
| Proteus mirabilis | 100.0 (12/12) | 36 - 213 | 12.5 | 11.3 - 14.6 |
Table 2. Growth Performance Results
Less than 100% detection was observed for some microorganisms, to include Capnocytophaga ochracea, Cardiobacterium hominis, Eikenella corrodens, Haemophilus parainfluenzae, Granulicatella adiacens, and Helicobacter cinaedi
Antimicrobial Neutralization
Neutralization of antimicrobials by adsorbent polymeric beads varies depending upon dosage level and timing of specimen collection. Internal studies have demonstrated that antimicrobials are effectively neutralized by the BacT/ALERT PF Plus medium. In these tests, antimicrobials were added in clinically relevant concentrations directly to culture bottles during inoculation with susceptible strains. The effectiveness of the antimicrobials was confirmed by parallel testing using a non-neutralizing medium as a control. Antimicrobials from the following categories were neutralized by the medium: penicillins, glycylcyclines, polyenes, macrolides, triazoles, echinocandins, cefazolin, cefoxitin, ceftaroline, aminoglycosides, fluoroquinolones, lincosamides, glycopeptides, and oxazolidinones. Antimicrobial neutralization was not achieved for ceftazidime or cefepime.
Less than complete neutralization was observed for ceftotaxime and ceftriaxone. Cefotaxime was neutralized at ranges of 50% peak serum level (PSL) to 2% PSL depending on the microorganism. Ceftriaxone was neutralized at ranges of 50% PSL to 1% PSL depending on the organism.
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Image /page/4/Picture/0 description: The image shows the logo for bioMerieux. The logo consists of the word "BIOMERIEUX" in all caps. Above the word is a black circle with a white line through it.
Potentially Interfering Substances
In-house seeded studies were conducted with plasma, blood, and blood clots. Aliquots of each of these fluids also received white blood cells at concentrations relevant to bacteremia in blood. Testing was conducted with and without microorganisms. These substances neither interfered with recovery and detection of organisms, nor did they generate false positive results in the absence of organisms.
Limit of Detection (LoD)
Data shows results from in-house seeded studies. A minimum of 30 replicates were tested per species. The data was generated using bottles at end of shelf life. Bottles inoculated with H. influenzae received 4 ml pooled human blood supplementation. At least 95% detection was achieved at LoD.
| Microorganism | Strain ID | LoD (CFU/bottle) |
|---|---|---|
| Candida albicans | ATCC 14053 | 6 |
| Enterobacter aerogenes | ATCC 13048 | 8 |
| Enterococcus faecalis | NCTC 12697 | 5 |
| Escherichia coli | NCTC 12923 | 4 |
| Haemophilus influenzae | ATCC 10211 | 6 |
| Klebsiella pneumoniae | STL 104016 | 4 |
| Listeria monocytogenes | ATCC 15313 | 6 |
| Pseudomonas aeruginosa | NCTC 12924 | 4 |
| Salmonella enterica | ATCC 14028 | 5 |
| Staphylococcus aureus | NCTC 10788 | 5 |
| Streptococcus pneumoniae | ATCC 6305 | 6 |
Table 3. Summary of LoD Data
NOTE: 96.7% of the bottles were subcultured within 30 minutes of being declared positive. STL 104016 was sourced from internal culture collection.
Within-Laboratory Precision (Repeatability)
Data represents results from in-house seeded studies conducted on 12 days on multiple instruments by multiple operators. Organisms were grown in the presence of clinically relevant concentrations of antimicrobials to which they are susceptible. In this seeded study BacT/ALERT PF Plus bottles were subcultured at least 24 hours after being flagged positive by the instrument. A minimum of 108 replicates were tested for each organism/antimicrobial combination.
| Sample Input | | CFU/bottle
(range) | % Recovery | | | | Time to Detection (hours) | |
|---------------|---------------|-----------------------|------------|-------|-------|---------|---------------------------|-------------|
| Organism | Antimicrobial | | Lot 1 | Lot 2 | Lot 3 | Overall | Mean | Range |
| C. albicans | Fluconazole | 140 - 364 | 100.0 | 100.0 | 100.0 | 100.0 | 26.0 | 22.8 - 31.3 |
| E. coli | Amikacin | 26 - 156 | 100.0 | 100.0 | 100.0 | 100.0 | 12.0 | 11.2 - 13.0 |
| K. pneumoniae | Levofloxacin | 108 - 170 | 100.0 | 100.0 | 100.0 | 100.0 | 13.4 | 11.7 - 15.2 |
| P. aeruginosa | Piperacillin | 80 - 148 | 100.0 | 97.2 | 100.0 | 99.1 | 19.2 | 17.4 - 24.1 |
| S. pneumoniae | Penicillin G | 9 - 505 | 100.0 | 100.0 | 100.0 | 100.0 | 13.2 | 11.6 - 15.5 |
| S. aureus | Vancomycin | 94 - 158 | 100.0 | 100.0 | 100.0 | 100.0 | 16.9 | 14.6 - 20.3 |
Table 4. Summary of the Within-Laboratory Precision Data
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Image /page/5/Picture/1 description: The image shows the logo for bioMerieux. The logo consists of the word "BIOMERIEUX" in all caps. Above the word is a circle with a vertical line through it.
Reproducibility
Data represents results from seeded studies conducted at three sites using a target of 162 replicates per site on 3 days with a minimum of two operators per site. Reproducibility was evaluated on each of 9 organisms. Two organisms (C. albicans and S. pneumoniae) were prepared via serial dilution and the other 7 organisms were prepared using BioBalls. C. albicans and S. pneumoniae were seeded into the PF Plus bottle, at a target inoculum of 100 CFU/bottle, with an acceptable range of 30-300 CFU/bottle and the other 7 organisms at a target range of 1-17 CFU/bottle. Actual inoculum ranged from 6 CFU/bottle to 700 CFU/bottle for the 30-300 CFU/bottle range, and from 1 CFU/bottle to 270 CFU/bottle for the 1-17 CFU/bottle range. Percent recovery reflects positive flag by the instrument, gram stain/subculture consistent with the seeded organisms.
| Sample Input | % Recovery | | | | Time to
Detection | | Inoculum
Ranges
(CFU/Bottle) |
|------------------|--------------------------------------------------|--------------------------------------------------|--------------------------------------------------|--------------------------------------------------|----------------------|---------------|------------------------------------|
| | Site 1 | Site 2 | Site 3 | Overall | Mean | Range | |
| S. aureus | 100.0%
(18/18) | 87.5%
(21/24) | 100.0%
(30/30) | 95.8%
(69/72) | 15.6 | 14.6-
16.7 | 2-11 |
| C. albicans | 100.0%
(18/18) | 83.3%
(30/36) | 100.0%
(33/33) | 93.1%
(81/87) | 36.6 | 24.6-
76.8 | 14-700 |
| E. coli | 100.0%
(27/27) | 77.8%
(21/27) | 100.0%
(30/30) | 92.9%
(78/84) | 12.8 | 11.8-
14.1 | 1-38 |
| P. aeruginosa | 100.0%
(24/24) | 75.0%
(18/24) | 97.0%
(32/33) | 91.4%
(74/81) | 18.4 | 17.1-
21.1 | 1-11 |
| E. faecalis | 100.0%
(18/18) | 79.2%
(19/24) | 96.7%
(29/30) | 91.7%
(66/72) | 13.9 | 12.6-
15.3 | 1-15 |
| E. aerogenes | 74.4%
(29/39) | 72.2%
(26/36) | 85.4%
(41/48) | 78.1%
(96/123) | 14.9 | 11.7-
20.8 | 1-270* |
| L. monocytogenes | 100.0%
(18/18) | 100.0%
(24/24) | 100.0%
(30/30) | 100.0%
(72/72) | 24.1 | 20.4-
36.4 | 1-14 |
| S. enterica | 100.0%
(24/24) | 75.0%
(18/24) | 100.0%
(33/33) | 92.6%
(75/81) | 13.5 | 2.3-
14.8 | 1-13 |
| S. pneumoniae | 100.0%
(30/30) | 100.0%
(36/36) | 100.0%
(21/21) | 100.0%
(87/87) | 14.2 | 11.6-
18.9 | 6-500 |
| Overall | 95.4%
(206/216)
95% CI:
91.7%,
97.8% | 83.5%
(213/255)
95% CI:
78.4%,
87.9% | 96.9%
(279/288)
95% CI:
94.2%.
98.6% | 92.0%
(698/759)
95% CI:
89.8%,
93.8% | | | |
Table 5. Summary of Reproducibility Data
*Plate count of 270 CFU/bottle was arrived at by serial dilution.
The above data includes repeat testing performed as a result of laboratory errors at a single site (i.e. contaminated bottles/reagents, colony counts out of range, and site failure to change bottle status after positive instrument signal and positive subculture). Data excluding the laboratory errors demonstrated 100%
6
recovery with the exception of E. aerogenes, which exhibited 85.0% recovery for all sites combined.
Delayed Entry
Results from seeded studies using 11 species* at target concentrations 100 CFU per bottle (acceptable range of 30 to 300 CFU per bottle) were generated at three sites. Actual inoculum levels ranged from 35 CFU/bottle to 290 CFU/bottle. All bottles contained human blood from healthy volunteers and were held at specified temperatures and times prior to loading into the BacT/ALERT instrument. Percent recovery reflects positive flag by the instrument, gram stain/subculture consistent with the seeded organisms.
| Sample Input | Incubation
Temperature (°C) | Hold Time
(hours) | % Recovery | Time to Detection from Sample
Inoculation
(Hold Time + Instrument TTD in
hours) | |
|----------------------------|--------------------------------|----------------------|--------------------|------------------------------------------------------------------------------------------|--------------|
| | | | | Mean | Range |
| Inoculated Test
Bottles | Control | No delay | 100.0% (459/459) | 14.3 | 8.5 - 84.0 |
| | 2-8 | 48 | 98.6% (292/296) | 63.7 | 57.5 - 103.2 |
| | 20-25 | 24 | 98.0% (291/297) | 31.8 | 26.2 - 74.4 |
| | 20-25 | 36 | 91.9% (272/296) | 41.8 | 38.0 - 70.5 |
| | 35-37 | 8 | 98.9% (454/459) | 16.1 | 10.2 - 53.8 |
| | 35-37 | 24 | 56.6%*** (259/458) | 28.3 | 26.0 - 74.4 |
| Negative
Controls | All conditions | | 0.5% (1/221)** | - | - |
Table 6. Summary of Delayed Entry Data
"Staphylococcus aureus, Candida krusei, Eschenchia coli, Klebsiella pneumoniae, Acinetobacter baumannii. Pseudomonas aeruginosa. Streptococcus pneumoniae. Enterococus faecium. Haemophilus influenzae, Neisseria meningitidis
** False positive observed during seeded study (1/221)
***CAUTION: Culture bottles held at 35 to 37°C for 24 hours or longer before loading may not detect microorganisms and should be subcultured.
Clinical Study Results (Blood Cultures)
A multi-center clinical study was conducted at three different geographic sites in the U.S. comparing the performance of the PF Plus and PF blood culture bottles for pediatric culture pairs that received blood volumes between 0.1 ml and 4 ml (compliant pairs). A total of 2188 bottle pairs were obtained from 1086 pediatric patients suspected of blood stream bacterial/veast infections. Subcultures of both bottles were performed when either bottle in the set was determined to be positive by the BacT/ALERT system. A pair of bottles was determined to have a positive status if the subculture of either the PF Plus or PF bottle was positive. A culture bottle was determined to be a "True Positive" if the culture was flagged positive by the BacT/ALERT System and resulted in growth of the isolate upon subculture of this bottle. True positive rates were calculated for the PF Plus and PF culture bottles, and the ratio of PF Plus true positives to PF true positives was calculated to compare performance. Clinical isolates recovered were classified as significant, contaminant, or unknown based on determination by the clinical trial sites.
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BIOMÉRIEUX
A total of 172 isolates were recovered from all compliant pediatric blood culture pairs with a positive status. There were a total of 145 bottle pairs that recovered at least 1 isolate by subculture of PF Plus or PF bottles. A total of 126 bottle pairs recovered a single isolate, 12 bottle pairs recovered two isolates, 6 bottle pairs recovered 3 isolates, and 1 bottle pair recovered 4 isolates. The total population reported in Table 7 comprises the 172 isolates recovered from positive bottle pairs and 2043 negative bottle pairs for a total of 2215 results. The BacT/ALERT PF Plus bottle detected a total of 140 isolates compared to the BacT/ALERT PF bottle that detected 128 isolates. Of the significant isolates, the BacT/ALERT PF Plus bottle detected a total of 91 isolates compared to the BacT/ALERT PF bottle that detected 77 isolates. One (1) false positive was identified by subculture of a positive BacT/ALERT PF Plus bottle and comprised 0.05% (1/2215) of the study population.
| Clinical Isolate
Determination | BacT/ALERT
PF Plus True
Positives | % of BacT/ALERT PF
Plus
True Positives in
Population | BacT/ALERT PF
True
Positives | % of BacT/ALERT PF
True
Positives In
Population | Ratio of True
Positives* |
|-----------------------------------|-----------------------------------------|---------------------------------------------------------------|------------------------------------|----------------------------------------------------------|-----------------------------|
| Significant | 91 | 4.1% (91/2215) | 77 | 3.5% (77/2215) | 1.182 |
| Contaminant | 24 | 1.1% (24/2215) | 29 | 1.3% (29/2215) | 0.828 |
| Unknown | 25 | 1.1% (25/2215) | 22 | 1.0% (22/2215) | 1.136 |
| Total | 140 | 6.3% (140/2215) | 128 | 5.8% (128/2215) | 1.094 |
Table 7. All Compliant Pairs with Single and Multiple Isolates Combined (Blood Cultures)
*Ninety six (96) isolates were detected by both PF Plus and PF, 44 isolates were detected only by PF Plus and 32 isolates were detected only by PF. The ratio of true positive rates for overall isolates was 1.094 (140/128) with a 95% Cl of (0.954,1.234).
Proposed labeling
The proposed labeling is complete.
Conclusion
The information in this premarket notification is complete and supports a substantial equivalence decision.
8
DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
JAN 2 5 2013
bioMérieux, Inc C/O Ms. Elizabeth Landon Staff Regulatory Affairs Specialist 100 Rodolphe Street Durham, NC 27712
Re: K121446
Trade/Device Name: BacT/ALERT PF Plus Culture Bottle Regulation Number: 21 CFR 2560 Regulation Name: Microbial Growth Monitor Regulatory Class: Class I Product Code: MDB Dated: January 14, 2013 Received: January 15, 2013
Dear Ms. Landon:
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 additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
9
Page 2 - Ms. Landon
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sally A. Hojvat
Sally A. Hojvat, M.Sc., Ph.D. Director
Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
10
INTENDED USE STATEMENT
510(k) Number (if known): K121446
Device Name: BacT/ALERT® PF Plus Culture Bottles
Intended Use:
BacT/ALERT® PF Plus Culture Bottles are used with the BacT/ALERT® Microbial Detection System in qualitative procedures for recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria and yeast) from blood.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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510(k) K121446