BD BACTEC™ Plus Aerobic/F Culture Vials are used in a qualitative procedure for the aerobic culture and recovery of microorganisms (bacteria and yeast) from blood. The principal use of this medium is with the BD BACTECTM fluorescent series instruments.

Device Description

The BD BACTECTM Plus Aerobic/F Culture Vials contain a bacterial growth medium intended for use in the qualitative culture and recovery of aerobic microorganisms (bacteria and yeast) from blood. It has been designed for blood volumes of three (3) to ten (10) milliliters and is used specifically with the BD BACTEC™ fluorescent-series instruments in monitoring of clinical blood specimens for the presence of microorganisms.

BD BACTECTM Plus Aerobic/F Culture Vials are supplied in a carton containing 50 vials. It is a nonsterile product.

AI/ML Overview

This document describes the performance assessment of the BD BACTEC™ Plus Aerobic/F Culture Vials, a modified device, against a predicate device (K113558) to establish substantial equivalence.

Here's a breakdown of the acceptance criteria and study details:

1. Table of acceptance criteria and the reported device performance:

The document doesn't explicitly state quantitative acceptance criteria in a dedicated table format with precise thresholds. Instead, it describes comparative "acceptance criteria" through statements of "no statistically relevant difference" or "no significant differences" between the modified and predicate devices for various analytical performance metrics.

However, based on the study findings, we can infer the implicit acceptance criteria:

Acceptance Criteria (Inferred)	Reported Device Performance (Summary from Tables 2, 3, 4, 5, 6)
Instrument Time to Detection (TTD): No statistically relevant difference in TTD between the modified and predicate device.	For the majority of organisms and conditions, the TTD difference between the modified and predicate device was very small, with 95% confidence intervals often spanning zero or indicating minor differences. Two isolates (Rothia mucilaginosa and Stenotrophomonas maltophilia) initially showed >10% difference in favor of the predicate, but further testing demonstrated this was strain-specific, not species-specific. The overall bootstrap analysis across all organisms showed negligible differences in TTD (e.g., -0.002 to -0.168 hours).
Percent Recovery (Sensitivity): No statistically relevant difference in recovery between the modified and predicate device.	Across all organisms, inoculum levels, and blood volumes, the percent recovery for both the predicate and modified devices was overwhelmingly 100%. In cases of lower inoculum levels (0-1 CFU), where recovery rates were expectedly lower, the differences between the two devices were generally small and varied in which device had slightly higher recovery, indicating no consistently better or worse performance. The overall recovery rates for 10-100 CFU were 100% for both devices.
False Negative Rate: No false negative vials observed.	Reported: 0% false negative vials for both devices. All instrument-negative vials did not yield growth upon terminal subculture.
False Positive Rate: No false positive vials observed.	Reported: 0% false positive vials for both devices. All vials inoculated with sterile human blood remained negative.
Instrument Compatibility: No significant differences in TTD and recovery across different BACTEC™ Fluorescent Series Instruments.	Reported: No recovery failures in any of the instruments (BACTEC™ FX, FX40, 9240, 9050) for either device. No significant TTD differences observed across the instruments (e.g., TTD differences generally close to zero with narrow 95% CIs).
Resin Performance (Antimicrobial Neutralization Capability): No statistically significant difference in recovery between lot pairs for different antimicrobial/organism combinations.	Reported: Minor variations in percent recovery between individual lots of the predicate and modified devices (e.g., Predicate Lot A: 47.77%, Modified Lot A: 47.13%). The combined data for all lots showed a very similar overall recovery (Predicate: 48.78% vs. Modified: 48.78% based on the provided table). The document explicitly states "There was no statistically significant difference observed between lot pairs."

2. Sample sized used for the test set and the data provenance:

Sample Size (Test Set):
- Instrument Time to Detection & Percent Recovery:
  - For 44 organisms at 10-100 CFU/vial: 264 vials per device (3 lots x 2 blood volumes x 44 organisms).
  - For 15 organisms at 0-1 and 1-10 CFU/vial: 45 vials per device per inoculum level per blood volume on BACTEC™ FX, totaling 90 vials per device for these specific conditions.
  - Total vials for TTD/Recovery: Approximately 444 vials per device (264 + 90 + 90).
- False Negative Rate: "115 instrument negative vials (57 in the modified device and 58 in the predicate device)" out of the 444 total vials from the TTD/Recovery study that were instrument negative.
- False Positive Rate: 120 vials per device (3 lots x 8 replicates x 5 blood volumes).
- Instrument Compatibility:
  - BACTEC™ FX and FX40: 264 paired sets per instrument (total 528 paired sets).
  - BACTEC™ 9240 and 9050: 96 paired sets per instrument (total 192 paired sets).
- Resin Performance: 314 antibiotic/organism combinations per lot per device. With 3 lots per device, this amounts to 942 vials per device. Overall, 1884 vials for this study.
Data Provenance: The studies were retrospective analytical performance studies, comparing a modified device to a previously cleared predicate device. The information does not specify the country of origin of the data, but given it's an FDA submission for a Becton, Dickinson and Company product, it is likely based on studies conducted in the US or in compliance with US regulatory standards. The testing involved controlled laboratory conditions using spiked (inoculated) blood samples, not clinical patient samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

This study is an analytical performance study for a microbial growth monitor. The "ground truth" for the test set (i.e., whether growth occurred and what the TTD was) was established by:

Direct Inoculation: Precise quantities (CFU/vial) of known bacterial and yeast organisms were inoculated into the vials.
Instrument Detection: The BD BACTEC™ fluorescent series instruments automatically detect and log growth (CO2 production) as part of their function.
Terminal Subculture: For vials that remained negative, a terminal subculture was performed to confirm the absence of viable microorganisms.

Therefore, this type of study does not rely on human experts to "establish ground truth" in the way a diagnostic imaging study might require radiologists. The ground truth is determined by the experimental design (known inoculum) and the objective readings of the instrument, verified by standard microbiological techniques (subculture).

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. As described above, the ground truth is established by controlled inoculation and objective instrument readings/terminal subculture, not by human interpretation or adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is an analytical performance study of a microbial growth medium and instrument system, not a clinical study involving human readers interpreting diagnostic images or data with or without AI assistance. The device is not an AI-powered system that assists human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

The device (BD BACTEC™ Plus Aerobic/F Culture Vials) is a component of an automated system (BD BACTEC™ fluorescent series instruments). The performance evaluated in this submission is effectively the "standalone" performance of the altered vial formulation within the automated BACTEC™ system, without direct human intervention in the detection process itself. Human involvement comes in collecting blood, inoculating vials, and interpreting the instrument's final positive/negative results. The study inherently assesses the algorithm (instrument's detection logic) as part of the overall system performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The ground truth used was controlled laboratory inoculation with known quantities of specific microorganisms, followed by objective instrument detection (fluorescence changes indicating CO2 production) and confirmation by terminal microbiological subculture for negative vials. This is a highly controlled "gold standard" for analytical performance in microbiology.

8. The sample size for the training set:

Not applicable. This is an analytical performance study comparing a modified in vitro diagnostic device component to a predicate device. It does not involve a "training set" in the context of machine learning model development. The study design is focused on demonstrating functional equivalence through empirical testing.

9. How the ground truth for the training set was established:

Not applicable, as there was no training set in the context of machine learning.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".

March 24, 2023

Becton, Dickinson and Company Susan Kircher Staff Regulatory Affairs Specialist 7 Loveton Circle Sparks, Maryland 21152

Re: K222591

Trade/Device Name: BD BACTEC Plus Aerobic/F Culture Vials Regulation Number: 21 CFR 866.2560 Regulation Name: Microbial Growth Monitor Regulatory Class: Class I, reserved Product Code: MDB Dated: August 25, 2022 Received: August 26, 2022

Dear Susan Kircher:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR

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for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Ribhi Shawar -S

Ribhi Shawar, Ph.D. (ABMM) Branch Chief. General Bacteriology and Antimicrobial Susceptibility Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K222591

Device Name BD BACTEC™ Plus Aerobic/F Culture Vials

Indications for Use (Describe)

Additional information

The device aids in the diagnosis of disease caused by pathogenic microorganisms and is automated on the BD BACTEC™ fluorescent series instruments.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Special 510(k) Summary

Summary Preparation Date: 8/25/2022

A. 510(k) Number:

K222591

B. Purpose of Submission:

To obtain a substantial equivalence determination for a premarket notification for the modified BD BACTECTM Plus Aerobic/F Culture Vials.

C. Measurand:

Aerobic microorganisms (bacteria and yeast) from blood

D. Type of Test:

Liquid culture medium for recovery of microorganisms from blood using fluorescent technology to detect increases in CO2 produced by the growth of microorganisms.

E. Applicant:

BD Diagnostic Systems Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152

Establishment Registration Number: 1119779

F. Proprietary and Established Name

BD BACTEC™ Plus Aerobic/F Culture Vials

G. Regulatory Information

Product Code	Classification	Regulation Section	Panel
MDB	Class I	21 CFR § 866.2560 MicrobialGrowth Monitor	83-Microbiology

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H. Intended Use/Indications for Use:

1. Intended Use:

Additional information

The device aids in the diagnosis of disease caused by pathogenic microorganisms and is automated on the BD BACTEC™ fluorescent series instruments.

Indication(s) for Use: 2.
Same as Intended Use
Special Conditions for Use Statement: 3.
RX - For Prescription Use Only
1. Special Instrument Requirements:
  The BD BACTEC™ fluorescent series instruments (BD BACTEC™ FX, BD BACTEC™ FX40, BD BACTEC™ 9240 and BD BACTECTM 9050) were evaluated using the software versions listed below.

Instrument	Software Version
BD BACTEC™ FX	6.40A
BD BACTEC™ 9240	4.95A
BD BACTEC™ 9050	2.01A2
BD BACTEC™ FX40	3.40A

I. Device Description

BD BACTECTM Plus Aerobic/F Culture Vials are supplied in a carton containing 50 vials. It is a nonsterile product.

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J. Substantial Equivalence1 Information:

1. Predicate Device Name:
  BD BACTEC™ Plus Aerobic/F Culture Vials
1. Predicate Device 510(k) Number:
  K113558
1. Comparison with Predicate Device:
  The similarities between the modified BD BACTEC™ Plus Aerobic/F Culture Vials and the current legally marketed predicate device, BD BACTEC™ Plus Aerobic/F Culture Vials (K113558) are summarized in comparison Table 1. The modified device formulation differs from that of the predicate device in the concentration of vitamins.

The modified BD BACTEC™ Plus Aerobic/F Culture Vials utilize the same specimens, test principles, and growth detection technology as the current legally marketed device.

1 The term "substantial equivalence" as used in this 510(k) notification is limited to the definition of substantial equivalence as found in the Federal Food, Drug and Cosmetic Act, as amended, and as applied under 21 CFR 807, Subpart E under which a device can be marketed without pre-market approval or reclassification of substantial equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to, or in support of substantial equivalence herein shall be construed as an admission against interest under the US Patent Laws or their application by the courts.

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Table 1. Comparison to the Predicate Device

	BD BACTECTM Plus Aerobic/F Culture VialsPredicate Device	BD BACTECTM Plus Aerobic/F CultureVialsModified Device
DeviceClass	I	Same
ProductCode	MDB	Same
IntendedUse	BD BACTECTM Plus Aerobic/F Culture Vials are usedin a qualitative procedure for the aerobic culture andrecovery of microorganisms (bacteria and yeast) fromblood. The principal use of this medium is with the BDBACTECTM fluorescent series instruments.	BD BACTEC™ Plus Aerobic/F CultureVials are used in a qualitative procedure forthe aerobic culture and recovery ofmicroorganisms (bacteria and yeast) fromblood. The principal use of this medium iswith the BD BACTEC™ fluorescent seriesinstruments.Additional informationThe device aids in the diagnosis of diseasecaused by pathogenic microorganisms and isautomated on the BD BACTECTMfluorescent series instruments.
OrganismsDetected	Aerobic bacteria and yeasts	Same
Technology	If microorganisms are present in the test sampleinoculated into the BD BACTEC™ vial, CO2 will beproduced when the organisms metabolize the substratespresent in the vial. Increases in the fluorescence of thevial sensor caused by the higher amount of CO2 aremonitored by the BD BACTECTM fluorescent seriesinstrument. Analysis of the rate and amount of CO2increase enables the BD BACTEC™ fluorescent seriesinstrument to determine if the vial is positive, i.e., thatthe test sample contains viable organisms. Thisqualitative culture functions as an aid to diagnosis andis automated on the BD BACTEC™ fluorescent seriesinstrument.	Same
SampleType	Blood	Same
BottleMaterial	Plastic	Same
SampleVolume	3-10 mL	Same
GrowthMedia	30 mL enriched Soybean-Casein Digest Broth	Same

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K. Principle of Operation:

If microorganisms are present in a test sample that is inoculated into the BD BACTEC™ Plus Aerobic/F Culture Vials, CO2 will be produced due to metabolism of substrates present in the vial. Increases in the fluorescence of the vial sensor caused by the higher amount of CO2 are monitored by BD BACTEC™ fluorescent series instruments. Analysis of the rate and amount of CO2 increase enables the BD BACTEC™ fluorescent series instrument to determine if the vial is positive, i.e., that the test sample contains viable organisms. This qualitative culture functions as an aid to diagnosis and is automated on the BD BACTEC™ fluorescent series instruments.

L. Performance Characteristics:

1. Analytical Performance

Six studies were conducted to demonstrate substantial equivalence between of the modified BD BACTEC™ Plus Aerobic/F Culture Vials to the current, legally marketed device, BD BACTEC™ Plus Aerobic/F Culture Vials (predicate). These studies included: Instrument Time to Detection, Percent Recovery (Sensitivity), False Negative Rate, False Positive Rate, BACTEC™ Instrument Compatibility, and Resin Performance (Antimicrobial Neutralization Capability).

Instrument Time to Detection

Instrument time to detection (TTD) was assessed using paired sets of the modified and predicate device. Three lots of each device were inoculated with blood volumes of 3 and 10 mL. All vials were inoculated with 44 organisms at a concentration of 10-100 CFU/vial. All vials were then placed into both a BACTEC™ FX and a BACTEC™ FX40 instrument resulting in a total of 264 vials at each blood volume condition. A subset of 15 organisms were also evaluated at a concentration of 0-1 and 1-10 CFU/vial at each blood volume on the BACTEC™ FX instrument for a total of 45 vials at each inoculum and blood volume condition. Data are summarized in Table 2.

There were two isolates that produced a > 10% difference at the 10-100 CFU inoculum level that were in favor of the predicate device. Rothia mucilaginosa and Stenotrophomonas maltophilia. Additional strains of each species were tested in triplicate. Results of this testing demonstrated the delay in TTD in the modified device was strain specific and not related to the organism species.

The results of this study indicate no statistically relevant difference in time to detection for the modified device when compared to the predicate device.

Organism	TargetCFU	BloodVolume(mL)	Predicate DeviceTTD (95% CI) [N]	Modified DeviceTTD (95% CI) [N]	TTD Difference(95%CI) [N]
Abiotrophia defectivaA49176	10-100	3	16.46 (16.340, 16.893)[6]	17.17 (16.872, 17.728)[6]	0.582 (0.250, 1.251) [6]
		10	16.26 (16.009, 16.674)[6]	17.18 (16.951, 17.484)[6]	0.917 (0.583, 1.168) [6]
Acinetobacter lwoffiiA17925	10-100	3	13.60 (13.242, 13.884)[6]	13.88 (13.771, 14.323)[6]	0.416 (-0.84, 0.916) [6]
		10	17.94 (14.579, 23.048)[6]	14.30 (14.106, 14.663)[6]	-3.751 (-8.835, 0.084) [6]
Aggregatibacteractinomycetemcomitans	10-100	3	25.57 (25.059, 26.572)[6]	25.40 (24.307, 26.573)[6]	-0.250 (-1.001, 0.334) [6]
Organism	TargetCFU	BloodVolume(mL)	Predicate DeviceTTD (95% CI) [N]	Modified DeviceTTD (95% CI) [N]	TTD Difference(95%CI) [N]
NCTC 9710		10	25.90 (25.242, 26.317) [6]	26.09 (25.052, 26.242) [6]	-0.083 (-0.993, 1.000) [6]
Aerococcus viridinsA11563	10-100	3	11.12 (10.851, 12.060) [6]	11.29 (11.016, 11.891) [6]	0.083 (-0.584, 0.666) [6]
		10	11.71 (11.430, 12.069) [6]	12.12 (11.707, 12.373) [6]	0.415 (-0.168, 0.749) [6]
Alcaligenes faecalisA8750	10-100	3	22.19 (21.250, 23.029) [6]	21.39 (21.080, 21.913) [6]	-0.834 (-1.417, 0.166) [6]
		10	24.16 (21.867, 26.865) [6]	21.03 (20.115, 22.738) [6]	-2.001 (-5.835, -1.168) [6]
Bacillus subtilisA82	10-100	3	25.32 (24.552, 26.172) [6]	24.31 (23.821, 24.839) [6]	-1.334 (-1.500, -0.249) [6]
		10	27.32 (27.073, 28.073) [6]	26.41 (25.814, 27.083) [6]	-1.000 (-1.500, -0.666) [6]
Candida albicansA18804	1-10	3	31.59 (31.423, 32.758) [3]	28.09 (27.089, 28.091) [3]	-4.501 (-4.666, -3.333) [3]
		10	35.09 (31.277, 37.252) [3]	28.92 (27.609, 29.084) [3]	-6.001 (-8.334, -3.668) [3]
	0-1	3	Only 1 paired detection*	Only 1 paired detection*	N/A
		10	Only 1 paired detection*	Only 1 paired detection*	N/A
Candida aurisAR 0378	10-100	3	22.10 (19.895, 24.208) [6]	19.67 (18.989, 20.622) [6]	-2.253 (-3.835, -0.831) [6]
		10	19.34 (18.843, 23.283) [6]	19.17 (18.760, 19.427) [6]	-0.418 (-3.856, 0.166) [6]
Candida glabrataA15545	10-100	3	67.47 (60.632, 76.150) [6]	32.61 (30.880, 34.341) [6]	-34.364 (-42.309, 29.752) [6]
		10	60.13 (53.885, 72.461) [6]	35.44 (33.083, 37.708) [6]	-24.274 (-35.169, -20.803) [6]
Candida glabrataA66032	10-100	3	64.87 (61.875, 69.053) [6]	29.59 (28.448, 31.744) [6]	-35.531 (-37.947, -32.531) [6]
		10	47.85 (42.084, 54.609) [6]	28.11 (26.166, 29.345) [6]	-21.501 (-25.335, -14.084) [6]
	1-10	3	96.79 (88.624, 101.123) [3]	35.62 (34.122, 40.121) [3]	-56.667 (-67.000, -53.001) [3]
		10	100.28 (91.288, 105.620) [3]	40.45 (37.951, 48.453) [3]	-62.334 (-65.168, -42.835) [3]
	0-1	3	Only 1 paired detection*	Only 1 paired detection*	N/A
		10	Only 1 paired detection*	Only 1 paired detection*	N/A
CardiobacteriumhominisNCTC 10426	10-100	3	45.15 (40.061, 49.911) [6]	44.90 (40.559, 50.410) [6]	0.082 (-0.501, 1.165) [6]
		10	45.57 (41.238, 51.321) [6]	45.48 (40.819, 50.821) [6]	-0.084 (-1.418, 0.499) [6]
Organism	TargetCFU	BloodVolume(mL)	Predicate DeviceTTD (95% CI) [N]	Modified DeviceTTD (95% CI) [N]	TTD Difference(95%CI) [N]
CorynebacteriumjeikeiumA43216	10-100	3	28.98 (27.820, 30.150) [6]	28.57 (28.313, 30.649) [6]	0.499 (-0.668, 0.749) [6]
	10-100	10	30.94 (26.827, 38.814) [6]	31.35 (27.076, 39.813) [6]	0.249 (-0.918, 2.333) [6]
	10-100	3	64.54 (60.644, 68.285) [6]	57.30 (55.226, 58.950) [6]	-7.084 (-9.835, -5.084) [6]
		10	73.23 (66.305, 88.745) [6]	63.13 (59.888, 65.290) [6]	-10.269 (-23.536, -5.167) [6]
CryptococcusneoformansA32045	1-10	3	69.99 (66.284, 71.491) [3]	66.11 (60.950, 66.452) [3]	-5.040 (-5.334, -3.873) [3]
	1-10	10	81.28 (77.613, 82.116) [3]	69.28 (68.611, 71.318) [3]	-10.798 (-12.670, -8.337) [3]
	0-1	3	Only 1 paired detection*	Only 1 paired detection*	N/A
		10	82.80 (79.630, 90.300) [3]	73.40 (69.833, 76.963) [2]	-7.816 (-12.965, -2.667) [2]
Eikinella corrodensA23834	10-100	3	30.82 (29.809, 32.319) [6]	32.31 (31.309, 33.151) [6]	-0.001 (0.166, 1.999) [6]
	10-100	10	31.25 (30.054, 32.647) [6]	30.91 (29.558, 32.311) [6]	-0.501 (-1.418, 0.749) [6]
Enterobacter cloacaeA35030	10-100	3	8.63 (8.525, 8.756) [6]	8.76 (8.527, 8.959) [6]	-0.000 (-0.001, 0.332) [6]
	10-100	10	9.03 (8.885, 9.420) [6]	9.11 (8.883, 9.503) [6]	0.082 (-0.168, 0.250) [6]
	10-100	3	9.78 (9.589, 9.985) [6]	9.92 (9.775, 10.153) [6]	0.165 (-0.001, 0.333) [6]
		10	10.01 (9.926, 10.178) [6]	10.07 (9.785, 10.343) [6]	-0.001 (-0.251, 0.333) [6]
Enterococcus faecalisA29212	1-10	3	11.63 (11.296, 11.631) [3]	11.21 (11.127, 11.296) [2]	-0.251 (-0.501, -0.001) [2]
		10	11.62 (11.459, 12.124) [3]	11.95 (11.625, 11.956) [3]	0.166 (-0.168, 0.333) [3]
	0-1	3	No paired detections*	No paired detections*	N/A
		10	No paired detections*	No paired detections*	N/A
	10-100	3	9.32 (9.153, 9.490) [6]	9.24 (9.142, 9.417) [6]	-0.084 (-0.334, 0.248) [6]
		10	9.57 (9.307, 9.992) [6]	9.48 (9.389, 10.072) [6]	-0.084 (-0.168, 0.332) [6]
Escherichia coliA25922	1-10	3	10.61 (10.279, 11.114) [3]	10.61 (10.444, 10.614) [3]	-0.168 (-0.500, 0.333) [3]
		10	11.78 (11.608, 12.109) [3]	10.78 (10.774, 11.444) [3]	-0.833 (-1.333, -0.334) [3]
	0-1	3	11.55 (11.465, 11.633) [2]	11.80 (11.465, 12.131) [2]	0.249 (-0.167, 0.666) [2]
		10	12.13 (12.126, 12.127) [2]	12.13 (11.959, 12.294) [2]	-0.004 (-0.167, 0.160) [2]
Granulicatella adiacensA43205	10-100	3	15.92 (15.318, 16.428) [6]	15.59 (15.234, 15.832) [6]	-0.501 (-0.834, 0.332) [6]
		10	16.91 (15.992, 17.252) [6]	16.75 (15.741, 17.084) [6]	-0.251 (-0.501, 0.166) [6]
Haemophilus influenzaeA19418	10-100	3	16.08 (14.383, 17.662) [6]	15.95 (14.634, 17.579) [6]	-0.000 (-0.293, 0.334) [6]
		10	15.09 (14.631, 17.057) [6]	15.51 (14.844, 17.223) [6]	0.330 (-0.084, 0.581) [6]
Organism	TargetCFU	BloodVolume(mL)	Predicate DeviceTTD (95% CI) [N]	Modified DeviceTTD (95% CI) [N]	TTD Difference(95%CI) [N]
	1-10	3	15.78 (15.609, 16.108) [3]	15.94 (15.774, 16.276) [3]	0.166 (-0.334, 0.666) [3]
		10	16.27 (15.940, 16.606) [3]	16.44 (16.270, 16.606) [3]	-0.001 (-0.168, 0.666) [3]
	0-1	3	No paired detections*	No paired detections*	N/A
		10	No paired detections*	No paired detections*	N/A
Haemophilus influenzae,type a	10-100	3	16.45 (15.042, 17.271) [6]	16.28 (14.625, 17.936) [6]	-0.001 (-0.584, 0.666) [6]
A9006		10	16.44 (13.453, 18.931) [6]	16.52 (13.787, 19.680) [6]	0.416 (-0.084, 0.833) [6]
Haemophilus influenzae,	10-100	3	17.63 (15.724, 19.783) [6]	18.04 (15.392, 21.281) [6]	0.416 (-0.585, 1.749) [6]
type bA10211		10	18.45 (14.137, 23.932) [6]	20.20 (14.219, 27.097) [6]	1.416 (-0.084, 3.667) [6]
		3	64.67 (54.259, 83.760) [6]	68.34 (56.343, 82.507) [6]	0.582 (-8.501, 12.416) [6]
	10-100	10	53.20 (45.585, 61.004) [6]	52.53 (49.085, 63.586) [6]	2.583 (-2.168, 5.000) [6]
Haemophilusparainfluenzae	1-10	3	79.99 (77.319, 94.656) [3]	69.49 (68.822, 74.987) [3]	-7.833 (-25.834, -5.001) [3]
A33392		10	68.65 (56.652, 73.986) [3]	75.49 (62.985, 77.985) [3]	1.500 (-5.668, 21.333) [3]
	0-1	3	No paired detections*	No paired detections*	N/A
		10	No paired detections*	No paired detections*	N/A
Kingella kingae	10-100	3	16.32 (15.902, 16.653) [6]	16.65 (15.995, 17.726) [6]	0.416 (-0.334, 1.415) [6]
A23330		10	16.56 (15.388, 18.325) [6]	16.81 (15.302, 18.574) [6]	0.083 (-0.251, 0.582) [6]
Klebsiella pneumoniae	10-100	3	8.62 (8.596, 8.771) [6]	8.53 (8.427, 8.689) [6]	-0.166 (-0.252, 0.083) [6]
A33495		10	8.78 (8.615, 9.102) [6]	8.78 (8.772, 9.104) [6]	0.081 (-0.168, 0.248) [6]
Leuconostoc species	10-100	3	32.22 (30.386, 34.989) [6]	32.14 (28.562, 37.90) [6]	-0.667 (-4.668, 6.333) [6]
A21435		10	32.81 (30.901, 48.995) [6]	32.82 (30.813, 42.313) [6]	-0.584 (-6.681, 0.499) [6]
	10-100	3	34.59 (33.819, 35.107) [6]	33.84 (33.319, 34.855) [6]	-0.251 (-1.501, 0.249) [6]
		10	36.59 (36.090, 37.340) [6]	36.75 (35.077, 37.852) [6]	0.166 (-1.751, 1.249) [6]
Micrococcus luteusA4698	1-10	3	38.17 (37.172, 39.670) [3]	37.67 (37.669, 40.671) [3]	-0.501 (-2.000, 3.500) [3]
		10	39.17 (39.166, 41.665) [3]	32.75 (24.832, 40.666) [2]	-7.667 (-16.833, 1.500) [2]
	0-1	3	No paired detections*	No paired detections*	N/A
		10	Only 1 paired detection*	Only 1 paired detection*	N/A
Neisseria gonorrhoeae		3	23.09 (22.511, 23.265) [6]	23.11 (22.586, 23.259) [6]	0.083 (-0.582, 0.584) [6]
A10150	10-100	10	23.51 (22.608, 24.246) [6]	23.09 (22.277, 23.579) [6]	-0.500 (-1.001, 0.084) [6]
Organism	TargetCFU	BloodVolume(mL)	Predicate DeviceTTD (95% CI) [N]	Modified DeviceTTD (95% CI) [N]	TTD Difference(95%CI) [N]
Neisseria meningitidisA13090	1-10	3	26.40 (25.400, 26.401)[3]	26.57 (26.563, 27.064)[3]	0.167 (0.166, 1.664) [3]
		10	24.94 (24.608, 26.730)[3]	26.11 (25.729, 26.276)[3]	1.333 (-1.001, 1.499) [3]
	0-1	3	Only 1 paired detection*	Only 1 paired detection*	N/A
		10	Only 1 paired detection*	Only 1 paired detection*	N/A
	10-100	3	33.57 (28.284, 46.981)[6]	36.57 (25.934, 44.647)[6]	-2.334 (-6.970, 7.618) [6]
		10	18.27 (17.639, 18.821)[6]	18.19 (17.939, 18.354)[6]	-0.085 (-0.585, 0.416) [6]
	1-10	3	27.08 (26.581, 27.084)[3]	24.58 (24.581, 27.083)[3]	-2.000 (-2.501, -0.000) [3]
		10	20.41 (20.412, 20.577)[3]	19.58 (19.076, 19.911)[3]	-0.834 (-1.501, -0.500) [3]
	0-1	3	No paired detections*	No paired detections*	N/A
		10	No paired detections*	No paired detections*	N/A
Pediococcus acidilacticiA25740	10-100	3	23.01 (22.067, 22.619)[6]	23.84 (23.065, 25.369)[6]	1.248 (0.582, 1.750) [6]
		10	20.62 (20.569, 20.842)[6]	21.59 (21.400, 22.449)[6]	1.000 (0.749, 1.667) [6]
Proteus mirabilisA8259	10-100	3	12.67 (12.441, 12.975)[6]	11.72 (11.468, 11.971)[6]	-1.084 (-1.336, -0.501) [6]
		10	15.14 (13.188, 19.930)[6]	11.94 (11.722, 12.264)[6]	-3.168 (-7.918, -1.250) [6]
Providencia stuartiiA25825	10-100	3	10.62 (10.531, 10.866)[6]	10.37 (10.194, 10.621)[6]	-0.251 (-0.584, -0.001) [6]
		10	11.28 (10.950, 11.455)[6]	11.03 (10.784, 11.203)[6]	-0.251 (-0.418, -0.000) [6]
	10-100	3	14.19 (14.091, 14.473)[6]	14.30 (14.090, 14.354)[6]	0.082 (-0.251, 0.166) [6]
		10	15.31 (14.515, 16.265)[6]	14.97 (14.515, 15.182)[6]	-0.501 (-1.167, 0.249) [6]
PseudomonasaeruginosaA27853	1-10	3	16.09 (15.584, 16.753)[3]	16.09 (15.919, 17.253)[3]	0.334 (-0.000, 0.501) [3]
		10	16.42 (16.415, 16.580)[3]	17.08 (17.082, 17.247)[3]	0.666 (0.666, 0.667) [3]
	0-1	3	17.10 (16.433, 17.430)[3]	17.27 (16.932, 17.763)[3]	0.333 (-0.166, 0.833) [3]
		10	17.34 (17.259, 17.426)[2]	17.76 (17.757, 18.427)[3]	0.416 (0.333, 0.498) [2]
Rothia mucilaginosaNCTC 10663	10-100	3	15.55 (14.882, 16.469)[6]	25.80 (23.551, 27.799)[6]	9.999 (7.999, 12.250) [6]
		10	15.80 (14.544, 16.811)[6]	20.38 (18.544, 21.810)[6]	4.667 (3.582, 5.332) [6]
SaccharomycescerevisiaeA9763	10-100	3	45.64 (40.508, 48.241)[6]	24.24 (23.505, 25.554)[6]	-21.334 (-23.168, -16.585) [6]
		10	31.06 (28.740, 33.835)[6]	25.32 (23.310, 27.085)[6]	-6.168 (-8.084, -3.668) [6]
Organism	TargetCFU	BloodVolume(mL)	Predicate DeviceTTD (95% CI) [N]	Modified DeviceTTD (95% CI) [N]	TTD Difference(95%CI) [N]
Staphylococcus aureusA25923	10-100	3	12.17 (11.785, 12.402)[6]	11.48 (11.256, 11.701)[6]	-0.751 (-0.918, -0.252) [6]
	10	11.42 (11.225, 11.613)[6]	10.61 (10.418, 10.892)[6]	-0.751 (-1.167, -0.418) [6]
Staphylococcus aureusA25923	1-10	3	14.43 (13.927, 14.429)[3]	12.92 (12.595, 13.259)[3]	-1.501 (-1.834, -0.668) [3]
	10	12.75 (12.583, 12.923)[3]	12.42 (12.089, 12.750)[3]	-0.168 (-0.834, -0.001) [3]
Staphylococcus aureusA25923	0-1	3	Only 1 paired detection*	Only 1 paired detection*	N/A
	10	Only 1 paired detection*	Only 1 paired detection*	N/A
Staphylococcus epidermidisA12228	10-100	3	17.31 (17.091, 17.742)[6]	15.07 (14.719, 15.757)[6]	-2.087 (-2.674, -1.833) [6]
	10	15.91 (15.563, 16.671)[6]	14.91 (14.389, 15.503)[6]	-1.089 (-1.338, -0.920) [6]
Staphylococcus epidermidisA12228	1-10	3	19.23 (19.068, 21.069)[3]	16.23 (16.066, 17.902)[3]	-3.167 (-3.168, -2.834) [3]
	10	17.73 (17.563, 18.064)[3]	17.56 (16.398, 18.562)[3]	-0.501 (-1.334, -0.999) [3]
Staphylococcus epidermidisA12228	0-1	3	Only 1 paired detection*	Only 1 paired detection*	N/A
	10	Only 1 paired detection*	Only 1 paired detection*	N/A
StenotrophomonasmaltophiliaA13637	10-100	3	27.07 (26.342, 27.610)[6]	29.34 (28.567, 32.775)[6]	2.494 (1.493, 5.666) [6]
	10	26.59 (24.081, 29.353)[6]	32.51 (28.155, 35.103)[6]	5.0245 (4.074, 6.418) [6]
StreptococcusagalactiaeA12928	10-100	3	8.79 (8.594, 9.070) [6]	8.96 (8.840, 9.317) [6]	0.248 (-0.003, 0.415) [6]
	10	9.21 (8756, 9.661) [6]	9.12 (8.921, 9.326) [6]	-0.167 (-0.335, 0.248) [6]
StreptococcuspneumoniaeA6301	10-100	3	11.52 (11.282, 11.630)[6]	11.46 (11.043, 11.590)[6]	-0.007 (-0.587, 0.249) [6]
	10	12.20 (11.731, 12.380)[6]	12.04 (11.604, 12.230)[6]	-0.254 (-0.675, 0.499) [6]
StreptococcuspneumoniaeA6303	10-100	3	11.15 (10.887, 11.542)[6]	11.13 (10.952, 11.396)[6]	-0.004 (-0.424, 0.333) [6]
	10	11.47 (11.131, 11.809)[6]	11.73 (11.372, 11.965)[6]	0.328 (-0.338, 0.662) [6]
StreptococcuspneumoniaeA6305	10-100	3	12.95 (12.697, 13.364)[6]	12.44 (12.277, 12.943)[6]	-0.421 (-0.588, -0.336) [6]
	10	13.38 (12.788, 13.941)[6]	13.19 (12.841, 13.462)[6]	-0.084 (-1.016, 0.488) [6]
StreptococcuspneumoniaeA6305	1-10	3	13.27 (13.264, 13.762)[3]	14.10 (13.928, 15.436)[3]	0.832 (0.166, 2.166) [3]
	10	14.93 (13.261, 15.593)[3]	15.34 (15.093, 15.591)[2]	0.083 (-0.499, 0.666) [2]
StreptococcuspneumoniaeA6305	0-1	3	No paired detections*	No paired detections*	N/A
	10	No paired detections*	No paired detections*	N/A
Streptococcuspneumoniae	10-100	3	12.11 (12.005, 12.402)[6]	12.17 (12.003, 12.504)[6]	-0.001 (-0.168, 0.333) [6]
Organism	TargetCFU	BloodVolume(mL)	Predicate DeviceTTD (95% CI) [N]	Modified DeviceTTD (95% CI) [N]	TTD Difference(95%CI) [N]
A700673		10	12.59 (12.432, 12.827)[6]	12.68 (12.502, 12.910)[6]	0.166 (-0.251, 0.332) [6]
Streptococcus pyogenes	10-100	3	10.16 (10.003, 10.387)[6]	10.41 (10.085, 10.554)[6]	0.249 (-0.084, 0.333) [6]
A19615		10	10.81 (10.482, 10.982)[6]	10.57 (10.396, 10.896)[6]	-0.168 (-0.501, 0.249) [6]
	10-100	3	14.60 (14.078, 15.364)[6]	15.01 (14.576, 15.281)[6]	0.499 (-0.167, 0.499) [6]
Streptococcus sanguinisA10556		10	14.76 (14.429, 15.017)[6]	14.86 (14.513, 15.167)[6]	0.166 (-0.251, 0.416) [6]
	1-10	3	16.56 (16.557, 16.892)[3]	18.06 (17.226, 19.056)[3]	1.166 (0.666, 2.499) [3]
		10	17.05 (16.721, 19.389)[3]	17.22 (17.053, 17.388)[3]	0.166 (-2.001, 0.333) [3]
	0-1	3	No paired detections*	No paired detections*	N/A
All organisms		10	Only 1 paired detection*	Only 1 paired detection*	N/A
	10-100	3	16.66 (15.809, 19.113) [264]	17.331 (15.523, 20.786)[264]	-0.002 (-0.168, -0.001) [264]
		10	17.083 (16.089, 18.906) [264]	17.328 (15.387, 19.012)[264]	-0.168 (-0.334, -0.001) [264]
	1-10	3	19.23 (16.108, 27.083) [45]	18.56 (16.150, 27.074) [44]	-0.501 (-2.417, -0.000) [44]
		10	18.06 (16.580, 24.943) [45]	17.56 (17.053, 25.729) [43]	-0.499 (-1.001, -0.001) [43]
	0-1	3	21.08 (16.433, 39.617)[N=17]	17.75 (14.443, 31.697)[N=16]	-0.167 (-10.016, 0.499) [N=10]
		10	20.08 (13.274, 42.679)[N=15]	24.82 (18.093, 41.637)[N=20]	-0.167 (-2.667, 0.498) [N=7]

Table 2. Instrument Time to Detection Stratified by Organism. Inoculum and Blood Volume (Bootstrap analysis)

{8}------------------------------------------------

{9}------------------------------------------------

{10}------------------------------------------------

{11}------------------------------------------------

{12}------------------------------------------------

{13}------------------------------------------------

At least two distinct values are required to generate a confidence interval

{14}------------------------------------------------

Percent Recovery

The percent recovery was also assessed using the same organisms, blood volumes, vial lots, instruments, and inoculum levels as defined in the TTD study.

The results of this testing indicated no statistically relevant difference in recovery and are summarized in Table 3.

Table 3. Percent Recovery Stratified by Organism, Inoculum and Blood Volume

Organism	TargetCFU	BloodVolume(mL)	Predicate Device PercentRecovery(# positive bottles/# totalbottles)	Modified Device PercentRecovery(# positive bottles/ # totalbottles)
Abiotrophia defectivaA49176	10-100	3	100.0% (6/6)	100.0% (6/6)
		10	100.0% (6/6)	100.0% (6/6)
Acinetobacter IwoffiiA17925	10-100	3	100.0% (6/6)	100.0% (6/6)
		10	100.0% (6/6)	100.0% (6/6)
Aggregatibacter actinomycetemcomitansNCTC 9710	10-100	3	100.0% (6/6)	100.0% (6/6)
		10	100.0% (6/6)	100.0% (6/6)
Aerococcus viridinsA11563	10-100	3	100.0% (6/6)	100.0% (6/6)
		10	100.0% (6/6)	100.0% (6/6)
Alcaligenes faecalisA8750	10-100	3	100.0% (6/6)	100.0% (6/6)
		10	100.0% (6/6)	100.0% (6/6)
Bacillus subtilisA82	10-100	3	100.0% (6/6)	100.0% (6/6)
		10	100.0% (6/6)	100.0% (6/6)
Candida albicansA18804	1-10	3	100.0% (3/3)	100.0% (3/3)
		10	100.0% (3/3)	100.0% (3/3)
	0-1	3	100.0% (3/3)	33.3% (1/3)
		10	33.3% (1/3)	66.7% (2/3)
Candida aurisAR 0378	10-100	3	100.0% (6/6)	100.0% (6/6)
		10	100.0% (6/6)	100.0% (6/6)
Candida glabrataA15545	10-100	3	100.0% (6/6)	100.0% (6/6)
		10	100.0% (6/6)	100.0% (6/6)
Candida glabrataA66032	1-10	3	100.0% (3/3)	100.0% (3/3)
		10	100.0% (3/3)	100.0% (3/3)
	0-1	3	33.3% (1/3)	33.3% (1/3)
		10	33.3% (1/3)	66.7% (2/3)
Cardiobacterium hominisNCTC 10426	10-100	3	100.0% (6/6)	100.0% (6/6)
		10	100.0% (6/6)	100.0% (6/6)
Corynebacterium jeikeiumA43216	10-100	3	100.0% (6/6)	100.0% (6/6)
		10	100.0% (6/6)	100.0% (6/6)
Cryptococcus neoformansA32045	1-10	3	100.0% (3/3)	100.0% (3/3)
		10	100.0% (3/3)	100.0% (3/3)
	0-1	3	66.7% (2/3)	33.3% (1/3)
		10	100.0% (3/3)	66.7% (2/3)
Eikinella corrodens	10-100	3	100.0% (6/6)	100.0% (6/6)
Organism	TargetCFU	BloodVolume(mL)	Predicate Device PercentRecovery(# positive bottles/# totalbottles)	Modified Device PercentRecovery(# positive bottles/ # totalbottles)
A23834		10	100.0% (6/6)	100.0% (6/6)
Enterobacter cloacaeA35030	10-100	3	100.0% (6/6)	100.0% (6/6)
		10	100.0% (6/6)	100.0% (6/6)
Enterococcus faecalisA29212	1-10	3	100.0% (3/3)	66.7% (2/3)
		10	100.0% (3/3)	100.0% (3/3)
	0-1	3	0.0% (0/3)	66.7% (2/3)
		10	33.3% (1/3)	0.0% (0/3)
Escherichia coliA25922	10-100	3	100.0% (6/6)	100.0% (6/6)
		10	100.0% (6/6)	100.0% (6/6)
	1-10	3	100.0% (3/3)	100.0% (3/3)
		10	100.0% (3/3)	100.0% (3/3)
	0-1	3	66.7% (2/3)	66.7% (2/3)
		10	66.7% (2/3)	66.7% (2/3)
Granulicatella adiacensA43205	10-100	3	100.0% (6/6)	100.0% (6/6)
		10	100.0% (6/6)	100.0% (6/6)
	10-100	3	100.0% (6/6)	100.0% (6/6)
		10	100.0% (6/6)	100.0% (6/6)
Haemophilus influenzaeA19418	1-10	3	100.0% (3/3)	100.0% (3/3)
		10	100.0% (3/3)	100.0% (3/3)
	0-1	3	0.0% (0/3)	33.3% (1/3)
		10	0.0% (0/3)	0.0% (0/3)
Haemophilus influenzaeA9006	10-100	3	100.0% (6/6)	100.0% (6/6)
		10	100.0% (6/6)	100.0% (6/6)
Haemophilus influenzaeA10211	10-100	3	100.0% (6/6)	100.0% (6/6)
		10	100.0% (6/6)	100.0% (6/6)
Haemophilus parainfluenzaeA33392	10-100	3	100.0% (6/6)	100.0% (6/6)
		10	100.0% (6/6)	100.0% (6/6)
	1-10	3	100.0% (3/3)	100.0% (3/3)
		10	100.0% (3/3)	100.0% (3/3)
	0-1	3	0.0% (0/3)	33.3% (1/3)
		10	0.0% (0/3)	33.3% (1/3)
Kingella kingaeA23330	10-100	3	100.0% (6/6)	100.0% (6/6)
		10	100.0% (6/6)	100.0% (6/6)
Klebsiella pneumoniaeA33495	10-100	3	100.0% (6/6)	100.0% (6/6)
		10	100.0% (6/6)	100.0% (6/6)
Leuconostoc speciesA21435	10-100	3	100.0% (6/6)	100.0% (6/6)
		10	100.0% (6/6)	100.0% (6/6)
Micrococcus luteusA4698	10-100	3	100.0% (6/6)	100.0% (6/6)
		10	100.0% (6/6)	100.0% (6/6)
	1-10	3	100.0% (3/3)	100.0% (3/3)
		10	100.0% (3/3)	66.7% (2/3)
	0-1	3	0.0% (0/3)	33.3% (1/3)
		10	33.3% (1/3)	33.3% (1/3)
Neisseria gonorrhoeaeA10150	10-100	3	100.0% (6/6)	100.0% (6/6)
		10	100.0% (6/6)	100.0% (6/6)
Organism	TargetCFU	BloodVolume(mL)	Predicate Device PercentRecovery(# positive bottles/# totalbottles)	Modified Device PercentRecovery(# positive bottles/ # totalbottles)
Neisseria meningitidisA13090	1-10	3	100.0% (3/3)	100.0% (3/3)
		10	100.0% (3/3)	100.0% (3/3)
	0-1	3	66.7% (2/3)	33.3% (1/3)
		10	33.35 (1/3)	66.7% (2/3)
	10-100	3	100.0% (6/6)	100.0% (6/6)
		10	100.0% (6/6)	100.0% (6/6)
Pediococcus acidilacticiA25740	10-100	3	100.0% (6/6)	100.0% (6/6)
		10	100.0% (6/6)	100.0% (6/6)
Proteus mirabilisA8259	10-100	3	100.0% (6/6)	100.0% (6/6)
		10	100.0% (6/6)	100.0% (6/6)
Providencia stuartiiA25825	10-100	3	100.0% (6/6)	100.0% (6/6)
		10	100.0% (6/6)	100.0% (6/6)
	10-100	3	100.0% (6/6)	100.0% (6/6)
		10	100.0% (6/6)	100.0% (6/6)
Pseudomonas aeruginosaA27853	1-10	3	100.0% (3/3)	100.0% (3/3)
		10	100.0% (3/3)	100.0% (3/3)
	0-1	3	100.0% (3/3)	100.0% (3/3)
		10	66.7% (2/3)	100.0% (3/3)
Rothia mucilaginosaNCTC 10663	10-100	3	100.0% (6/6)	100.0% (6/6)
		10	100.0% (6/6)	100.0% (6/6)
Saccharomyces cerevisiaeA9763	10-100	3	100.0% (6/6)	100.0% (6/6)
		10	100.0% (6/6)	100.0% (6/6)
	10-100	3	100.0% (6/6)	100.0% (6/6)
		10	100.0% (6/6)	100.0% (6/6)
Staphylococcus aureusA25923	1-10	3	100.0% (3/3)	100.0% (3/3)
		10	100.0% (3/3)	100.0% (3/3)
	0-1	3	66.7% (2/3)	33.3% (1/3)
		10	33.3% (1/3)	66.7% (2/3)
	10-100	3	100.0% (6/6)	100.0% (6/6)
		10	100.0% (6/6)	100.0% (6/6)
Staphylococcus epidermidisA12228	1-10	3	100.0% (3/3)	100.0% (3/3)
		10	100.0% (3/3)	100.0% (3/3)
	0-1	3	66.7% (2/3)	33.3% (1/3)
		10	33.3% (1/3)	66.7% (2/3)
Stenotrophomonas maltophiliaA13637	10-100	3	100.0% (6/6)	100.0% (6/6)
		10	100.0% (6/6)	100.0% (6/6)
Streptococcus agalactiaeA12928	10-100	3	100.0% (6/6)	100.0% (6/6)
		10	100.0% (6/6)	100.0% (6/6)
Streptococcus pneumoniaeA6301	10-100	3	100.0% (6/6)	100.0% (6/6)
		10	100.0% (6/6)	100.0% (6/6)
Streptococcus pneumoniaeA6303	10-100	3	100.0% (6/6)	100.0% (6/6)
		10	100.0% (6/6)	100.0% (6/6)
Streptococcus pneumoniae	10-100	3	100.0% (6/6)	100.0% (6/6)
Organism	TargetCFU	BloodVolume(mL)	Predicate Device PercentRecovery(# positive bottles/# totalbottles)	Modified Device PercentRecovery(# positive bottles/ # totalbottles)
A6305	1-10	10	100.0% (6/6)	100.0% (6/6)
		3	100.0% (3/3)	100.0% (3/3)
		10	100.0% (3/3)	66.7% (2/3)
	0-1	3	0.0% (0/3)	0.0% (0/3)
		10	0.0% (0/3)	0.0% (0/3)
Streptococcus pneumoniaeA700673	10-100	3	100.0% (6/6)	100.0% (6/6)
		10	100.0% (6/6)	100.0% (6/6)
Streptococcus pyogenesA19615	10-100	3	100.0% (6/6)	100.0% (6/6)
		10	100.0% (6/6)	100.0% (6/6)
Streptococcus sanguinisA10556	1-10	3	100.0% (6/6)	100.0% (6/6)
		10	100.0% (6/6)	100.0% (6/6)
		3	100.0% (3/3)	100.0% (3/3)
	0-1	10	100.0% (3/3)	100.0% (3/3)
		3	0.0% (0/3)	0.0% (0/3)
	10	33.3% (1/3)	33.3% (1/3)
All organisms	10-100	3	100.0% (264/264)	100.0% (264/264)
		10	100.0% (264/264)	100.0% (264/264)
	1-10	3	100.0% (45/45)	97.8% (44/45)
		10	100.0% (45/45)	95.6% (43/45)
	0-1	3	37.8% (17/45)	35.6% (16/45)
		10	33.3% (15/45)	44.4% (20/45)

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False Negative Rate

The false negative rate was determined from the Percent Recovery study which was conducted on the BACTEC™ FX Instrument, resulting in a total of 444 vials (264 + 90 + 90 per device). Following the 120-hour incubation protocol, there were 115 instrument negative vials (57 in the modified device and 58 in the predicate device). All negative vials failed to yield growth upon terminal subculture. As a result, there were no false negative vials observed in this study.

False Positive Rate

False positive rate was assessed by inoculating the modified and the predicate device with various volumes of blood. Eight replicates from each of 3 lots were inoculated with either 2, 4, 6, 8 or 10 mL of freshly drawn human blood without organism for a total of 120 vials per each device. All vials were negative following the 120-hour incubation protocol. No false positive vials were observed in this study.

Instrument Compatibility

The instrument compatibility study was designed to assess performance equivalency (Recovery and TTD) of the modified and predicate device across four BACTEC™ Fluorescent Series Instruments (BACTECTM FX, BACTECTM FX40, BACTECTM 9240 and BACTEC™ 9050). Testing on the BACTEC™ FX and BACTEC™ FX40 utilized an inoculum of 10-100 CFU/vial and the same study design and blood volumes as described in the TTD study for a total of 264 paired sets per instrument. Testing on the BACTECTM 9240 and BACTEC™ 9050 utilized a subset of 16 organisms at the same inoculum level and blood volumes as used in the BACTEC™ FX and BACTEC™ FX40 testing for a total of 96 pairs.

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There were no recovery failures in any of the instruments for either the modified or predicate device. Additionally, there were no significant differences in TTD and these results are summarized in Table 4 and Table 5.

BACTECTMInstrument	Total NumberPositive Vials	Predicate Device[TTD (95% CI)]	Modified Device[TTD (95% CI)]	TTD Difference(95% CI)
BACTECTM FX	264	16.28 (15.37, 17.81)	16.42 (15.14, 18.47)	-0.001 (-0.168, -0.000)
BACTECTM FX40	264	17.40 (16.48, 19.56)	18.07 (16.07, 20.11)	-0.168 (-0.334, -0.001)

Table 4. BACTECTM FX and BACTECTM FX40 TTD (Bootstrap Analysis)

Table 5. BACTEC™ FX, BACTEC™ 9240 and BACTEC™ 9050 TTD (Bootstrap Analysis)

BACTEC™Instrument	Total NumberPositive Vials	Predicate Device[TTD (95% CI)]	Modified Device[TTD (95% CI)]	TTD Difference(95% CI)
BACTEC™ FX	96	13.52 (11.75, 15.46)	13.12 (11.51, 14.61)	-0.167 (-0.415, 0.001)
BACTEC™ 9240	96	13.50 (11.09, 15.67)	12.82 (11.00, 13.84)	-0.333 (-0.500, 0.000)
BACTEC™ 9050	96	13.92 (11.67, 16.50)	13.17 (11.25, 14.67)	-0.167 (-0.334, 0.000)

The results of this testing support the use of the modified device on all four BACTEC™ Fluorescent Series Instruments.

Resin Performance

Resin performance was assessed using 7 mL of blood, 17 antimicrobials and organisms representing a diversity of MICs to each antimicrobial agent, for a total of 314 antibiotic/organism combinations per lot of media. The recovery was stratified for each lot of the modified and the predicate device and is summarized in Table 6. There was no statistically significant difference observed between lot pairs. All negative vials were also negative on terminal subculture.

Table 6. Percent Recovery Stratified by Device and Lot

Device and Lot	Total VialsTested	NegativeVials	Percent Recovery
Predicate Device - Lot A	314	164	47.77
Modified Device – Lot A	314	166	47.13
Predicate Device - Lot B	314	151	51.91
Modified Device – Lot B	314	163	48.09
Predicate Device - Lot C	314	162	48.41
Modified Device – Lot C	314	159	49.36
Combined data	1884	965	48.78

2. Clinical Studies

Not applicable; seeded analytical studies were performed to compare the modified BD BACTECTM Plus Aerobic/F Culture Vials to the predicate BD BACTECT™ Plus Aerobic/F Culture Vials.

M. Proposed Labeling:

The labeling supports the finding of substantial equivalence for this device.

N. Conclusion:

The studies conducted support the performance of the modified BD BACTEC™ Plus Aerobic/F Culture Vials as substantially equivalent to the predicate device.

Regulation Number and Section

§ 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.