(254 days)
Not Found
No
The summary describes a microbial detection system that uses a colorimetric sensor and reflected light to monitor CO2 production, which indicates microbial growth. There is no mention of AI or ML being used in the detection or analysis process. The performance studies focus on analytical and clinical validation of the culture medium and detection system's ability to recover and detect microorganisms, not on algorithmic performance.
No.
The device is used for the recovery and detection of microorganisms from blood and other sterile body fluids in qualitative procedures, which is a diagnostic purpose, not therapeutic.
Yes
This device is a diagnostic device as its intended use is for the recovery and detection of anaerobic and facultative anaerobic microorganisms from blood and other normally sterile body fluids, which is crucial for diagnosing bacteremia/fungemia.
No
The device description clearly outlines a physical culture bottle containing reagents and polymeric beads, which is used in conjunction with a hardware system (BacT/ALERT® Microbial Detection System) that utilizes optical sensors to detect microbial growth. This involves significant hardware components and physical interactions, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the BacT/ALERT® FN Plus Culture Bottles are used "in qualitative procedures for recovery and detection of anaerobic and facultative anaerobic microorganisms from blood and other normally sterile body fluids." This describes a test performed in vitro (outside the body) on a sample taken from a patient to provide information about their health status (presence of microorganisms).
- Device Description: The description details a "culture medium bottle" used with a "Microbial Detection System" to detect microorganisms in patient samples. This is a classic description of an IVD system.
- Mechanism of Action: The device works by detecting the production of CO2 by microorganisms growing in the culture medium. This is a biological process occurring in vitro within the bottle.
- Clinical Studies: The submission includes detailed results from clinical studies using patient samples (blood and sterile body fluids) to evaluate the performance of the device in detecting microorganisms. This is a requirement for demonstrating the clinical utility of an IVD.
- Predicate Device: The submission identifies a predicate device (BacT/ALERT® FN Culture Bottle) which is also an IVD used for similar purposes.
All of these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
BacT/ALERT® FN Plus Culture Bottles are used with the BacT/ALERT® Microbial Detection System in qualitative procedures for recovery and detection of anaerobic and facultative anaerobic microorganisms from blood and other normally sterile body fluids.
Product codes (comma separated list FDA assigned to the subject device)
MDB
Device Description
The proposed resin formulation reagent (BacT/ALERT® FN Plus Culture Bottle) is an improvement upon the cleared charcoal formulation reagent (BacT/ALERT® FN Culture Bottle). The BacT/ALERT® FN 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® FN Culture Bottle contains charcoal in the complex growth medium for its antimicrobial neutralization properties. Charcoal is eliminated in the proposed BacT/ALERT® FN Plus Culture Bottle, and is replaced with two types of adsorbent polymeric beads in the complex growth medium. The proposed BacT/ALERT® FN Plus Culture Bottle (resin) is optimized to increase antimicrobial neutralization properties and to increase the clarity of Gram stains in comparison to the predicate BacT/ALERT® FN Culture Bottle (charcoal) while maintaining the ability to detect and recover microorganisms.
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 or other normally sterile body fluid samples (except urine) 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 metabolize 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-areen to vellow. 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 and other normally sterile body fluids (amniotic fluid, continuous ambulatory peritoneal dialysis (CAPD) fluid, cerebrospinal fluid (CSF), peritoneal fluid, pleural fluid, and synovial fluid).
Indicated Patient Age Range
Adult patients
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Analytical Testing - Analytical Sensitivity: Growth Performance
Data represent results from in-house seeded studies with and without 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 and sterile body fluids.
For samples with blood: Staphylococcus aureus (100.0% recovery, Mean TTD 14.6 hrs), Escherichia coli (100.0% recovery, Mean TTD 10.9 hrs), Bacteroides fragilis (100.0% recovery, Mean TTD 29.7 hrs), Streptococcus pneumoniae (100.0% recovery, Mean TTD 16.5 hrs), Clostridium perfringens (100.0% recovery, Mean TTD 17.3 hrs), Klebsiella pneumoniae (100.0% recovery, Mean TTD 11.2 hrs), Fusobacterium nucleatum (70.6% recovery, Mean TTD 74.4 hrs), Streptococcus agalactiae (100.0% recovery, Mean TTD 16.9 hrs), Enterococcus faecalis (100.0% recovery, Mean TTD 13.7 hrs), Parvimonas micra (80.0% recovery, Mean TTD 51.4 hrs), Enterobacter cloacae (100.0% recovery, Mean TTD 11.9 hrs), Proteus mirabilis (100.0% recovery, Mean TTD 11.4 hrs), Eggerthella lenta (86.7% recovery, Mean TTD 41 hrs), Staphylococcus epidermidis (100.0% recovery, Mean TTD 21 hrs), Listeria monocytogenes (100.0% recovery, Mean TTD 17.1 hrs), Clostridium tertium (100.0% recovery, Mean TTD 12.5 hrs), Clostridium septicum (50.0% recovery, Mean TTD 31.7 hrs), Peptoniphilus asaccharolyticus (60.0% recovery, Mean TTD 50.9 hrs).
For samples without blood: Staphylococcus aureus (100% recovery, Mean TTD 21.8 hrs), Escherichia coli (100% recovery, Mean TTD 11.6 hrs), Bacteroides fragilis (66.7% recovery, Mean TTD 97.2 hrs), Streptococcus pneumoniae (100% recovery, Mean TTD 17.5 hrs), Clostridium perfringens (100.0% recovery, Mean TTD 27.1 hrs), Klebsiella pneumoniae (100% recovery, Mean TTD 12.6 hrs), Fusobacterium nucleatum (75.0% recovery, Mean TTD 56.1 hrs), Streptococcus agalactiae (100% recovery, Mean TTD 25.9 hrs), Enterococcus faecalis (100% recovery, Mean TTD 22.4 hrs), Parvimonas micra (0.0% recovery), Enterobacter cloacae (100% recovery, Mean TTD 13 hrs), Proteus mirabilis (100% recovery, Mean TTD 11.9 hrs), Eggerthella lenta (66.7% recovery, Mean TTD 46 hrs), Staphylococcus epidermidis (100% recovery, Mean TTD 29.3 hrs), Listeria monocytogenes (100% recovery, Mean TTD 19.2 hrs), Clostridium tertium (100% recovery, Mean TTD 14.8 hrs), Clostridium septicum (40.0% recovery, Mean TTD 43.4 hrs), Peptoniphilus asaccharolyticus (25.0% recovery, Mean TTD 44.7 hrs).
Less than 100% detection was observed for some species, to include Capnocytophaga ochracea, Cardiobacterium hominis, Haemophilus parainfluenzae, and Granulicatella adiacens.
Antimicrobial Neutralization
Internal studies demonstrated that antimicrobials are effectively neutralized by the BacT/ALERT FN Plus medium based on 100% recovery of organisms tested. The following antimicrobials/antimicrobial categories were neutralized: imipenem, oxacillin, glycylcycline, ceftaroline, aminoglycosides, fluoroquinolones, macrolides, cefoxitin, lincosamides, ketolides, and glycopeptides.
Antimicrobial neutralization was not achieved for ceftazidime, ceftriaxone, or cefepime.
Less than complete neutralization was observed for cefotaxime, cefazolin, ampicillin, penicillin, and ertapenem.
Potentially Interfering Substances
In-house seeded studies indicated that cerebrospinal fluid, pleural fluid, synovial fluid, plasma, blood, blood clots, and white blood cells neither interfered with recovery and detection of organisms, nor did they generate false positive results in the absence of organisms.
Limit of Detection (LoD)
In-house seeded studies at end of shelf life. A minimum of 30 replicates tested per species.
Bacteroides fragilis: 5 CFU/bottle
Clostridium perfringens: 4 CFU/bottle
Enterobacter aerogenes: 8 CFU/bottle
Enterococcus faecalis: 4 CFU/bottle
Escherichia coli: 4 CFU/bottle
Listeria monocytogenes: 6 CFU/bottle
Salmonella enterica: 5 CFU/bottle
Staphylococcus aureus: 4 CFU/bottle
Streptococcus pneumoniae: 6 CFU/bottle
At least 95% detection was achieved at LoD.
Within Laboratory Precision (Repeatability)
Results from in-house seeded studies conducted on 12 days on multiple instruments by multiple operators. Organisms grown in presence of clinically relevant concentrations of antimicrobials. Minimum 108 replicates tested for each organism/antimicrobial combination.
B. fragilis + Imipenem: 100.0% recovery, Mean TTD 36.9 hrs
C. perfringens + Vancomycin: 98.2% recovery, Mean TTD 14.5 hrs
S. aureus + Oxacillin: 100.0% recovery, Mean TTD 17.7 hrs
Reproducibility
Seeded studies conducted at three sites using a target of 144 replicates per site on 3 days with a minimum of two operators per site.
Staphylococcus aureus: 92.9% agreement to expected (Overall from multiple sites), Mean TTD 20.2 hrs
Escherichia coli: 93.3% agreement to expected, Mean TTD 12.8 hrs
Enterococcus faecalis: 94.3% agreement to expected, Mean TTD 24.6 hrs
Clostridium perfringens: 98.2% agreement to expected, Mean TTD 12.2 hrs
Enterobacter aerogenes: 86.5% agreement to expected, Mean TTD 14.6 hrs
Listeria monocytogenes: 100.0% agreement to expected, Mean TTD 22.8 hrs
Salmonella enterica: 93.6% agreement to expected, Mean TTD 13.3 hrs
Streptococcus pneumoniae: 100.0% agreement to expected, Mean TTD 17.5 hrs
Overall agreement: 94.8% (95% CI: 92.9%, 96.3%)
Excluding laboratory errors, 100% recovery with the exception of E. aerogenes which exhibited 96.3% recovery for all sites combined.
Delayed Entry
Seeded studies using 6 species (Staphylococcus aureus, Escherichia coli, Streptococcus pneumoniae, Enterococus faecium, Bacteroides fragilis, Clostridium perfringens) at target concentrations of 100 CFU/bottle generated at three sites. All bottles contained human blood and were held at specified temperatures and times prior to loading.
Control (No delay): 100.0% recovery, Mean TTD from inoculation is the same as instrument TTD.
2-8°C, 48 hours hold: 100.0% recovery, Mean TTD from inoculation 63.3 hrs
20-25°C, 24 hours hold: 100.0% recovery, Mean TTD from inoculation 34.7 hrs
20-25°C, 36 hours hold: 100.0% recovery, Mean TTD from inoculation 43.6 hrs
35-37°C, 8 hours hold: 100.0% recovery, Mean TTD from inoculation 17.7 hrs
35-37°C, 24 hours hold: 80.0% recovery, Mean TTD from inoculation 28.6 hrs
Negative Controls: 0.0% recovery.
Clinical Study Results (Blood Culture)
Multi-center clinical study at three sites in the U.S. comparing FN Plus and FN blood culture bottles for anaerobic culture pairs (6-10 ml blood volumes). 2514 anaerobic bottle pairs from 1080 adult patients were studied.
Total isolates recovered: 312 from 289 positive bottle pairs.
FN Plus detected 282 isolates while FN detected 192 isolates.
Significant isolates: FN Plus detected 202, FN detected 150. Ratio of True Positives for Significant Isolates: 1.347.
Contaminant isolates: FN Plus detected 58, FN detected 30. Ratio of True Positives for Contaminant Isolates: 1.933.
Unknown isolates: FN Plus detected 22, FN detected 12. Ratio of True Positives for Unknown Isolates: 1.833.
Overall True Positive Rate: FN Plus 11.2% (282/2514), FN 7.6% (192/2514).
Overall Ratio of True Positives: 1.469 (282/192) with a 95% Cl of (1.317, 1.621).
162 isolates detected by both, 120 only by FN Plus, 30 only by FN.
False positives: 3/2537 (0.12%) for FN Plus.
Clinical Study Results (Sterile Body Fluid Cultures)
Multi-center clinical study at four sites in the U.S. and Canada comparing FN Plus and FN culture bottles with SBF specimens (amniotic fluid, CAPD fluid, CSF, peritoneal fluid, pleural fluid, synovial fluid). 339 bottle pairs from 310 adult patients.
Total isolates recovered: 77 from 61 positive bottle pairs.
FN Plus detected 72 isolates while FN detected 59 isolates.
Significant isolates: FN Plus detected 52, FN detected 50. Ratio of True Positives for Significant Isolates: 1.040.
Contaminant isolates: FN Plus detected 12, FN detected 2. Ratio of True Positives for Contaminant Isolates: 6.000.
Unknown isolates: FN Plus detected 8, FN detected 7. Ratio of True Positives for Unknown Isolates: 1.143.
Overall True Positive Rate: FN Plus 21.2% (72/339), FN 17.4% (59/339).
Overall Ratio of True Positives: 1.220 (72/59) with a 95% CI of (1.044, 1.396).
54 isolates detected by both, 18 only by FN Plus, 5 only by FN.
False positives: 0/355 for FN Plus.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Analytical Sensitivity: (Recovery Rate for seeded studies)
Staphylococcus aureus: 100.0% (with blood), 100% (no blood)
Escherichia coli: 100.0% (with blood), 100% (no blood)
Bacteroides fragilis: 100.0% (with blood), 66.7% (no blood)
Streptococcus pneumoniae: 100.0% (with blood), 100% (no blood)
Clostridium perfringens: 100.0% (with blood), 100.0% (no blood)
Klebsiella pneumoniae: 100.0% (with blood), 100% (no blood)
Fusobacterium nucleatum: 70.6% (with blood), 75.0% (no blood)
Streptococcus agalactiae: 100.0% (with blood), 100% (no blood)
Enterococcus faecalis: 100.0% (with blood), 100% (no blood)
Parvimonas micra: 80.0% (with blood), 0.0% (no blood)
Enterobacter cloacae: 100.0% (with blood), 100% (no blood)
Proteus mirabilis: 100.0% (with blood), 100% (no blood)
Eggerthella lenta: 86.7% (with blood), 66.7% (no blood)
Staphylococcus epidermidis: 100.0% (with blood), 100% (no blood)
Listeria monocytogenes: 100.0% (with blood), 100% (no blood)
Clostridium tertium: 100.0% (with blood), 100% (no blood)
Clostridium septicum: 50.0% (with blood), 40.0% (no blood)
Peptoniphilus asaccharolyticus: 60.0% (with blood), 25.0% (no blood)
Limit of Detection (LoD) % Detection
At least 95% detection was achieved at LoD for all listed microorganisms.
Reproducibility: % Agreement to Expected
Overall for all organisms and sites: 94.8% (95% CI: 92.9%, 96.3%)
Staphylococcus aureus: 96.3% (Site 1), 79.2% (Site 2), 100.0% (Site 3)
Escherichia coli: 100.0% (Site 1), 79.2% (Site 2), 100.0% (Site 3)
Enterococcus faecalis: 100.0% (Site 1), 83.3% (Site 2), 97.0% (Site 3)
Clostridium perfringens: 100.0% (Site 1), 96.8% (Site 2), 100.0% (Site 3)
Enterobacter aerogenes: 90.0% (Site 1), 75.0% (Site 2), 90.5% (Site 3)
Listeria monocytogenes: 100.0% (Site 1), 100.0% (Site 2), 100.0% (Site 3)
Salmonella enterica: 100.0% (Site 1), 79.2% (Site 2), 100.0% (Site 3)
Streptococcus pneumoniae: 100.0% (Site 1), 100.0% (Site 2), 100.0% (Site 3)
Delayed Entry: % Recovery
100.0% for all conditions except 35-37°C for 24 hours (80.0% recovery).
Negative Controls: 0.0% recovery.
Clinical Study (Blood Cultures):
True Positive Rate (FN Plus): 11.2% (282/2514)
True Positive Rate (FN): 7.6% (192/2514)
False Positives (FN Plus): 0.12% (3/2537)
Ratio of True Positives (Overall): 1.469 (282/192) with a 95% Cl of (1.317, 1.621)
Clinical Study (Sterile Body Fluid Cultures):
True Positive Rate (FN Plus): 21.2% (72/339)
True Positive Rate (FN): 17.4% (59/339)
False Positives (FN Plus): 0% (0/355)
Ratio of True Positives (Overall): 1.220 (72/59) with a 95% CI of (1.044, 1.396)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K12/455
BacT/ALERT® FN Plus Culture Bottle
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®FN Plus
Device Identification
Trade Name: BacT/ALERT® FN 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: | Patricia Murphy, Staff Regulatory Affairs Specialist |
| Telephone # | 919-620-2270 |
| Fax# | 919-620-2548 |
| Preparation Date: | May 14, 2012 |
Intended Use of the Device:
- BacT/ALERT® FN Plus Culture Bottles are used with the BacT/ALERT® Microbial Detection System in qualitative procedures for recovery and detection of anaerobic and facultative anaerobic microorganisms from blood and other normally sterile body fluids.
1
BacT/ALERT® FN Plus Culture Bottle
Image /page/1/Picture/1 description: The image shows the logo for bioMerieux. The logo consists of the word "BIOMERIEUX" in a blocky, sans-serif font. A black circle with a white horizontal line through it sits above the text, and a thin vertical line bisects the circle and extends down between the "E" and "R" in "BIOMERIEUX."
Description of the Device:
The proposed resin formulation reagent (BacT/ALERT® FN Plus Culture Bottle) is an improvement upon the cleared charcoal formulation reagent (BacT/ALERT® FN Culture Bottle). The BacT/ALERT® FN 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® FN Culture Bottle contains charcoal in the complex growth medium for its antimicrobial neutralization properties. Charcoal is eliminated in the proposed BacT/ALERT® FN Plus Culture Bottle, and is replaced with two types of adsorbent polymeric beads in the complex growth medium. The proposed BacT/ALERT® FN Plus Culture Bottle (resin) is optimized to increase antimicrobial neutralization properties and to increase the clarity of Gram stains in comparison to the predicate BacT/ALERT® FN Culture Bottle (charcoal) while maintaining the ability to detect and recover microorganisms.
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 or other normally sterile body fluid samples (except urine) 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 metabolize 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-areen to vellow. 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® FN Culture Bottle
Predicate device 510(k) number(s) K020815
Comparison with predicate
The BacT/ALERT FN Plus Culture Bottle is claimed substantially equivalent to the BacT/ALERT FN Culture Bottle (K020815).
2
| Culture Bottle Characteristics: Changes versus K020815 | |
|---|---|
| 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 software code (in detection software) occurred. |
| Released with firmware version B.40 on BacT/ALERT Microbial | |
| Detection Systems | |
| The structure of the detection algorithm remains unchanged. | |
| No change was made to the initial value threshold of the | |
| BacT/ALERT® FN Plus bottle type knowledge base. | |
| Applicable variables in software controlling barcode recognition were | |
| adjusted to enable recognition of the new bottle type. |
Table 1 Similarities and differences between the bottles are outlined below:
Performance Characteristics
Analytical Testing
Analytical Sensitivity: Growth Performance
Data represent results from in-house seeded studies with and without 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 and sterile body. fluids.
Table 2 Growth Performance Results
| Blood | No Blood | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Microorganism | % | ||||||||||
| Recovery | |||||||||||
| (n) | Range | ||||||||||
| CFU/bottle | Time to Detection | ||||||||||
| (hours) | % | ||||||||||
| Recover | |||||||||||
| y* (n=3) | Range | ||||||||||
| CFU/bottle | Time to | ||||||||||
| Detection | |||||||||||
| (hours) | |||||||||||
| Mean | Range | Mean | Range | ||||||||
| Staphylococcus | |||||||||||
| aureus | 100.0 | ||||||||||
| (15/15) | 54 - 150 | 14.6 | 12.9 - 16.7 | 100 | 116 - 150 | 21.8 21.3 - | |||||
| 22.0 | |||||||||||
| Escherichia coli | 100.0 | ||||||||||
| (15/15) | 73 - 254 | 10.9 | 10.4 - 12.4 | 100 | 73 - 176 | 11.6 10.4 -- | |||||
| 12.9 | |||||||||||
| Bacteroides | |||||||||||
| fraqilis | 100.0 | ||||||||||
| (18/18) | 9 - 154 | 29.7 | 24.3 - 43.6 | 66.7 | |||||||
| (2/3) | 19 - 154 | 97.2 79.2 - | |||||||||
| 115.2 | |||||||||||
| Streptococcus | 100.0 | 4 - 260 | 16.5 | 11.5 - 43.8 | 100 | 4 - 25 | 17.5 16.0 - |
3
BIOME RIETX
BacT/ALERT® FN Plus Culture Bottle
| pneumoniae | (15/15) | 19.3 | ||||||
|---|---|---|---|---|---|---|---|---|
| Clostridium | ||||||||
| perfringens | 100.0 | |||||||
| (18/18) | 58 - 210 | 17.3 | 12.0 - 40.1 | 100.0 | ||||
| (8/8) | 76 - 210 | 27.1 | 14.1 - | |||||
| 35.7 | ||||||||
| Klebsiella | ||||||||
| pneumoniae | 100.0 | |||||||
| (15/15) | 89 - 123 | 11.2 | 10.4 - 13.1 | 100 | 95 - 123 | 12.6 | 12.1 - | |
| 13.4 | ||||||||
| Fusobacterium | ||||||||
| nucleatum | 70.6 | |||||||
| (12/17) | 19 - 204 | 74.4 | 36.0 - | |||||
| 108.0 | 75.0 | |||||||
| (3/4) | 19 - 116 | 56.1 | 41.2 - | |||||
| 64.8 | ||||||||
| Streptococcus | ||||||||
| agalactiae | 100.0 | |||||||
| (15/15) | 14 - 194 | 16.9 | 12.7 - 28.9 | 100 | 21 - 34 | 25.9 | 20.5 - | |
| 33.4 | ||||||||
| Enterococcus | ||||||||
| faecalis | 100.0 | |||||||
| (15/15) | 63 - 259 | 13.7 | 11.9 - 19.4 | 100 | 71 - 169 | 22.4 | 17.8 - | |
| 24.8 | ||||||||
| Parvimonas | ||||||||
| micra | 80.0 | |||||||
| (16/20) | 46 - 154 | 51.4 | 37.3 - 69.6 | 0.0 (0/4) | 46 - 154 | - | ||
| Enterobacter | ||||||||
| cloacae | 100.0 | |||||||
| (15/15) | 111 - 200 | 11.9 | 11.1 - 12.5 | 100 | 111 - 185 | 13 | 11.9 - | |
| 14.7 | ||||||||
| Proteus mirabilis | 100.0 | |||||||
| (15/15) | 36 - 213 | 11.4 | 10.9 - 12.5 | 100 | 36 - 213 | 11.9 | 11.5 - | |
| 12.7 | ||||||||
| Eggerthella | ||||||||
| lenta | 86.7 | |||||||
| (13/15) | 83 - 175 | 41 | 34.8 - 60.0 | 66.7 | ||||
| (2/3) | 83 - 151 | 46 | 44.0 - | |||||
| 48.0 | ||||||||
| Staphylococcus | ||||||||
| epidermidis | 100.0 | |||||||
| (15/15) | 44 - 135 | 21 | 17.4 - 25.3 | 100 | 44 - 105 | 29.3 | 24.5 - | |
| 36.8 | ||||||||
| Listeria | ||||||||
| monocytogenes | 100.0 | |||||||
| (15/15) | 121 - 251 | 17.1 | 15.5 - 19.3 | 100 | 121 - 251 | 19.2 | 17.7 - | |
| 20.3 | ||||||||
| Clostridium | ||||||||
| tertium | 100.0 | |||||||
| (15/15) | 24 | 12.5 | 11.4 - 13.5 | 100 | 24 | 14.8 | 14.1 - | |
| 16.0 | ||||||||
| Clostridium | ||||||||
| septicum | 50.0 | |||||||
| (20/40) | 25 - 146 | 31.7 | 13.9 - 62.4 | 40.0 | ||||
| (2/5) | 90 - 146 | 43.4 | 17.1 - | |||||
| 69.6 | ||||||||
| Peptoniphilus | ||||||||
| asaccharolyticus | 60.0 | |||||||
| (12/20) | 49 - 296 | 50.9 | 34.4 - 79.2 | 25.0 | ||||
| (1/4) | 81 - 296 | 44.7 |
Less than 100% detection was observed for some species, to include Capnocytophaga ochracea, Cardiobacterium hominis, Haemophilus parainfluenzae, and Granulicatella adiacens.
*In case of less than 100% recovery, it is recommended to add blood such as sterile defibrinated horse blood (10% v/v) 3
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 FN Plus medium based on 100% recovery of organisms tested. In these tests,
4
BIOMÉRIEUX
antimicrobials were added in clinically relevant concentrations directly to culture bottles during inoculation with susceptible strains of obligate and facultative anaerobic microorganisms. The effectiveness of the antimicrobials was confirmed by parallel testing using a non-neutralizing medium as a control. Studies demonstrated that the following antimicrobials/antimicrobial categories were neutralized by the medium: imipenem, oxacillin, glycylcycline, ceftaroline, aminoglycosides, fluoroquinolones, macrolides. cefoxitin, a lincosamides, ketolides, and glycopeptides.
Antimicrobial neutralization was not achieved for ceftazidime, ceftriaxone, or cefepime.
Less than complete neutralization was observed for cefotaxime, cefazolin, ampicillin, penicillin, and ertapenem. Cefotaxime was neutralized at ranges of 40% peak serum level (PSL) to 3% PSL depending on the microorganism. Cefazolin was neutralized at ranges of 25% PSL to 5% PSL depending on the microorganism. Ertapenem was neutralized at 5% PSL. Ampicillin was neutralized at 75% PSL for. E. faecalis. Penicillin was neutralized at 120% PSL for S. pneumoniae. No neutralization was observed for C. perfringens at 100% PSL of either ampicillin or penicillin.
Potentially Interfering Substances .
In-house seeded studies were conducted with cerebrospinal fluid, pleural fluid, synovial fluid, plasma, blood, and blood clots, Aliquots of each of these fluids also received white blood cells at concentrations relevant to bacteremia in each given body fluid. White blood cells and blood clots were added because sepsis can lead to elevation of white blood cells and activation of the coaqulation cascade. 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 in Table 3 shows results from in-house seeded studies. A minimum of 30. replicates were tested per species. Data in Table 3 was generated using bottles at end of shelf life. Bottles inoculated with B. fragilis and S. pneumoniae received 1 ml pooled human blood supplementation. At least 95% detection was achieved at LoD.
Table 3 Summary of LoD Data
| Microorganism
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Strain ID | LoD (CFU/bottle) |
|---|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ----------- | ------------------ |
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| Bacteroides fragilis | ATCC 25285 | 5 |
|---|---|---|
| Clostridium perfringens | NCTC 8798 | 4 |
| Enterobacter aerogenes | ATCC 13048 | 8 |
| Enterococcus faecalis | NCTC 12697 | 4 |
| Escherichia coli | NCTC 12923 | 4 |
| Listeria monocytogenes | ATCC 15313 | 6 |
| Salmonella enterica | ATCC 14028 | 5 |
| Staphylococcus aureus | NCTC 10788 | 4 |
| Streptococcus pneumoniae | ATCC 6305 | 6 |
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 FN 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 |
| B. fragilis | Imipenem | 136 - 406 | 100.0 | 100.0 | 100.0 | 100.0 | 36.9 | 30.2 -
55.2 |
| C. perfringens | Vancomycin | 75 - 204 | 100.0 | 94.4 | 100.0 | 98.2 | 14.5 | 11.1 -
22.0 |
| S. aureus | Oxacillin | 94 - 158 | 100.0 | 100.0 | 100.0 | 100.0 | 17.7 | 15.1 -
24.3 |
Table 4 Summary of the Within-Laboratory Precision Data
Reproducibility
Data represents results from seeded studies conducted at three sites using a target of 144 replicates per site on 3 days with a minimum of two operators per site. Reproducibility was evaluated on each of 8 organisms. One organism (S. pneumoniae) was prepared via serial dilution and the other 7 organisms were prepared using BioBalls. S. pneumoniae was seeded into the FN 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. The actual inoculum ranged from 5 CFU/bottle to 500 CFU/bottle for the 30-300
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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 and . Gram stain/subculture consistent with the seeded organism.
| Sample Input | % Agreement to Expected* | | | | Time to
Detection | | Inoculum
Range |
|-----------------------------|----------------------------|----------------------------|----------------------------|----------------------------|----------------------|---------------|-------------------|
| | Site 1 | Site 2 | Site 3 | Overall | Mean | Range | (CFU/bottle) |
| Staphylococcus
aureus | 96.3%
(26/27) | 79.2%
(19/24) | 100.0%
(33/33) | 92.9%
(78/84) | 20.2 | 18.5-
35.7 | 2-12 |
| Escherichia coli | 100.0%
(18/18) | 79.2%
(19/24) | 100.0%
(33/33) | 93.3%
(70/75) | 12.8 | 11.4-
20.8 | 2-11 |
| Enterococcus
faecalis | 100.0%
(30/30) | 83.3%
(20/24) | 97.0%
(32/33) | 94.3%
(82/87) | 24.6 | 17.9-
30.4 | 2-15 |
| Clostridium
perfringens | 100.0%
(18/18) | 96.8%
(61/63) | 100.0%
(30/30) | 98.2%
(109/111) | 12.2 | 10.2-
17.3 | 3-122 |
| Enterobacter
aerogenes | 90.0%
(27/30) | 75.0%
(18/24) | 90.5%
(38/42) | 86.5%
(83/96) | 14.6 | 11.9-
16.7 | 1-270 |
| Listeria
monocytogenes | 100.0%
(21/21) | 100.0%
(24/24) | 100.0%
(33/33) | 100.0%
(78/78) | 22.8 | 20.6-
37.0 | 1-13 |
| Salmonella
enterica | 100.0%
(24/24) | 79.2%
(19/24) | 100.0%
(30/30) | 93.6%
(73/78) | 13.3 | 12.4-
14.4 | 1-16 |
| Streptococcus
pneumoniae | 100.0%
(30/30) | 100.0%
(36/36) | 100.0%
(18/18) | 100.0%
(84/84) | 17.5 | 13.3-
23.1 | 5-500 |
| Overall | 98.0%
(194/198) | 88.9%
(216/243) | 98.0%
(247/252) | 94.8%
(657/693) | | | |
| | 95% CI:
94.9%,
99.5% | 95% CI:
84.3%,
92.6% | 95% CI:
95.4%,
99.4% | 95% CI:
92.9%,
96.3% | | | |
Table 5 Summary of Reproducibility Data
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% recovery with the exception of E. aerogenes which exhibited 96.3% recovery for all sites combined.
Delayed Entry
Results from seeded studies using 6 species*, at target concentrations of 100 CFU/bottle (acceptable range of 30-300 CFU/bottle) were generated at three sites. Actual inoculum levels ranged from 41 CFU/bottle to 253 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 and Gram stain/subculture consistent with the seeded organism.
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Table 6 Summary of Delayed Entry Data
| Sample
Input | Incubation
Temperature
(°C) | Hold Time
(hours) | % Recovery | Time to Detection from Sample
Inoculation
(Hold Time + Instrument TTD in
hours) | |
|-------------------------------|-----------------------------------|----------------------|-------------------|------------------------------------------------------------------------------------------|-------------|
| | Control | No delay | 100.0%
(89/89) | Mean | Range |
| | 2-8 | 48 | 100.0%
(65/65) | 63.3 | 50.1 - 90.4 |
| Inoculated
Test
Bottles | 20-25 | 24 | 100.0%
(62/62) | 34.7 | 26.0 - 79.2 |
| | 20-25 | 36 | 100.0%
(62/62) | 43.6 | 38.0 - 78.6 |
| | 35-37 | 8 | 100.0%
(72/72) | 17.7 | 10.0 - 53.4 |
| | 35-37 | 24 | 80.0%
(64/80) | 28.6 | 26.0 - 52.3 |
| Negative
Controls | All conditions | | 0.0%
(0/51) | - | - |
- Staphylococcus aureus, Escherichia coli, Streptococcus pneumoniae, Enterococus faecium, Bacteroides fragilis, Clostridium perfringens
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 Culture)
A multi-center clinical study was conducted at three different geographic sites in the U.S. comparing performance of the FN Plus and FN blood culture bottles for anaerobic culture pairs that received blood volumes between 6 ml and 10 ml (compliant pairs). A total of 2514 anaerobic bottle pairs were obtained from 1080 adult patients suspected of blood stream bacterial/yeast infections. Subcultures of both bottles were performed for any bottle in the set determined to be positive by the BacT/ALERT system. A pair of bottles was determined to have a positive status if subculture of either the FN Plus or FN 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
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of this bottle. True positive rates were calculated for the FN Plus and FN culture bottles and the ratio of FN Plus true positives to FN 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.
A total of 312 isolates were recovered from all compliant anaerobic blood culture pairs with a positive status. There were a total of 289 bottle pairs that recovered at least 1 isolate by subculture of FN Plus or FN bottles. A total of 266 bottle pairs recovered a single isolate and 23 bottle pairs recovered two isolates. The total population reported in Table 7 comprises the 312 isolates recovered from positive bottle pairs and 2225 negative bottle pairs for a total of 2537 results. The FN Plus bottle detected a total of 282 isolates compared to the FN bottle that detected 192 isolates. Of the significant isolates, the FN Plus bottle detected a total of 202 isolates compared to the FN bottle that detected 150 significant isolates. Three false positives were identified on subculture of positive FN Plus bottles and comprised 0:12% (3/2537) of the study population.
| Clinical
Determination | FN Plus True
Positives | % of FN Plus True
Positives in
Population | FN True
Positives | % of FN True
Positives in
Population | Ratio of
True
Positives |
|---------------------------|---------------------------|-------------------------------------------------|----------------------|--------------------------------------------|-------------------------------|
| Significant | 202 | 8.0% (202/2514) | 150 | 6.0% (150/2514) | 1.347 |
| Contaminant | 58 | 2.3% (58/2514) | 30 | 1.2% (30/2514) | 1.933 |
| Unknown | 22 | 0.9% (22/2514) | 12 | 0.5%
(12/2514) | 1.833 |
| Total | 282 | 11.2% (282/2514) | 192 | 7.6% (192/2514) | 1.469 |
Table 7 All Compliant Pairs With Single and Multiple Isolates Combined (Blood Cultures)
One hundred sixty two (162) isolates were detected by both FN Plus and FN. 120 isolates were detected only by FN Plus and 30 isolates were detected only by FN. *The ratio of true positive rates for overall isolates was 1.469 (282/192) with a 95% Cl of (1.317, 1.621)'
Clinical Study Results - (Sterile Body Fluid Cultures)
A multi-center clinical study was conducted at four different geographic sites in the U.S. and Canada comparing the performance of the FN Plus and FN culture bottles with sterile body fluid specimens (SBF). A total of 339 bottle pairs were obtained from 310 adult patients suspected of SBF bacterial/yeast infections. Sterile body fluid types evaluated were amniotic fluid, continuous ambulatory peritoneal dialysis (CAPD) fluid, cerebrospinal fluid (CSF), peritoneal fluid, pleural fluid, and synovial fluid. Clinical Isolates recovered were classified as significant, contaminant, or unknown based on determination by the clinical trial sites.
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A total of 77 isolates were recovered from all anaerobic SBF culture pairs with a positive status. There were a total of 61 bottle pairs that recovered at least 1 isolate by subculture of FN Plus or FN bottles. A total of 50 bottle pairs recovered a single isolate, 7 bottle pairs recovered two isolates, 3 bottle pairs recovered 3 isolates, and 1 bottle pair recovered 4 isolates. The total population reported in Table 8 comprises the 77 isolates recovered from positive bottle pairs and 278 negative bottle pairs for a total of 355 results. The FN Plus bottle detected a total of 72 isolates compared to the FN bottle that detected 59 isolates. Of the significant isolates, the FN Plus bottle detected a total of 52 isolates compared to the FN bottle that detected 50 isolates. No false positives were identified for the FN Plus bottle from the study population (0/355).
Table 8 below compares results of the BacT/ALERT FN Plus to BacT/ALERT FN SBF cultures that yielded single or multiple isolates on subculture.
| Clinical
Determination | FN Plus
True
Positive
s | % of FN True
Positives in
Population | FN True
Positives | % of FN True
Positives in
Population | Ratio of True
Positives |
|---------------------------|----------------------------------|--------------------------------------------|----------------------|--------------------------------------------|----------------------------|
| Significant | 52 | 15.3% (52/339) | 50 | 14.7% (50/339) | 1.040 |
| Contaminant | 12 | 3.5% (12/339) | 2 | 0.6% (2/339) | 6.000 |
| Unknown | 8 | 2.5% (8/339) | 7 | 2.1% (7/339) | 1.143 |
| Total | 72 | 21.2% (72/339) | 59 | 17.4% (59/339) | 1.220 |
Table 8 All Pairs With Single and Multiple Isolates Combined (Sterile Body Fluid Cultures)
Fifty four (54) isolates were detected by both FN Plus and FN. 18 isolates were detected only by FN Plus and 5 isolates were detected only by FN. The ratio of true positive rates for overall isolates was 1.220 (72/59) with a 95% CI of (1.044, 1.396)
Proposed Labeling
The proposed labeling is complete.
Conclusion:
The information in the premarket notification is complete and supports a substantial equivalence decision.
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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
bioMerieux. Inc. c/o Patricia (Trish) Murphy Staff Regulatory Affairs Specialist 100 Rodolphe Street Durham, NC 27712
Re: K121455
Trade/Device Name: BacT/ALERT® FN Plus Culture Bottle Regulation Number: 21 CFR 866.2560 Regulation Name: Microbial Growth Monitor Regulatory Class: Class I Product Code: MDB Dated: January 11, 2013 Received: January 14, 2013
Dear Ms. Murphy:
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
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Page 2 - Ms. Murphy
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
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INTENDED USE STATEMENT
510(k) Number (if known): K121455
Device Name: BacT/ALERT® FN Plus Culture Bottles
Intended Use:
BacT/ALERT® FN Plus Culture Bottles are used with the BacT/ALERT® Microbial Detection System in qualitative procedures for recovery and detection of anaerobic and facultative anaerobic microorganisms from blood and other normally sterile body fluids.
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)
Sabara
Division Sign-Off
Page 1 of 1
Office of In Vitro Diagnostics and Radiological Health
K1 21455
510(k)