The BACTEC® MYCO/F Lytic culture vials when used with the 9000 Blood Culture series of instrumentation are intended as an adjunct to routine blood culture for patients suspected of having mycobacteria, yeast and fungi septicemia. Extended incubation times (7 days for yeast, 30 days for fungi, and 42 days for mycobacteria) will permit recovery of mycobacteria and fungi when more rapidly growing organisms are not present. This medium may also be used for the culture of sterile body fluids when yeast or fungi are suspected.

Device Description

BACTEC MYCO/F LYTIC Culture medium is a Middlebrook 7H9 and Brain Heart Infusion broth formulation for the recovery of mycobacteria from blood specimens and fungi from blood and sterile body fluids. The range of specimen volume which can be cultured is one to five mL. with optimum recovery obtained at three to five mL. Specific modifications were made to enhance the growth and recovery of mycobacteria, veast, and fungi. These modifications include ferric ammonium citrate to provide an iron source for specific strains of mycobacteria and fungi, the addition of saponin as a blood lysing agent and the addition of specific proteins and sugars to provide nutritional supplements. Each vial contains a sensor which can detect decreases in oxygen concentration in the vial resulting from microorganism and growth. The sensor is monitored by the BACTEC 9000 Blood Culture Systems for increasing fluorescence which is proportional to the decrease in oxygen. A positive determination indicates the presumptive presence of viable microorganisms in the vial.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

The BACTEC MYCO/F LYTIC Blood Culture Medium is deemed substantially equivalent to predicate devices (BACTEC 13A for mycobacteria and BACTEC NR FUNGAL for yeast/fungi) based on internal and clinical studies demonstrating "equivalent performance." While explicit numerical acceptance criteria for recovery rates or time to detection are not provided as fixed thresholds, the studies aim to show that the new device performs comparably or better than the predicate devices across various clinically relevant scenarios.

Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria (Implied by Substantial Equivalence Goal)	Reported Device Performance (BACTEC MYCO/F LYTIC)	Predicate Device Performance (BACTEC 13A / BACTEC NR FUNGAL)	Notes
Recovery of Mycobacteria (Clinical)	Equivalent or improved recovery compared to BACTEC 13A.	10 (9%) isolates recovered only by Myco/F Lytic.	3 (3%) isolates recovered only by BACTEC 13A.	Myco/F Lytic demonstrated improved unique recovery for mycobacteria. Total 111 pathogenic mycobacteria isolates.
Recovery of Yeast & Fungi (Clinical)	Equivalent or improved recovery compared to ISOLATOR™ System.	7 (22%) isolates recovered only by Myco/F Lytic.	6 (19%) isolates recovered only by ISOLATOR™ System.	Myco/F Lytic demonstrated slightly improved unique recovery for yeast/fungi. Total 32 pathogenic yeast/fungal isolates.
Recovery of Yeast & Fungi (Internal)	Equivalent recovery and time to detection (TTD) compared to BACTEC NR FUNGAL.	Improved recovery of Histoplasma capsulatum and Malesezzia furfur. Equivalent for various Candida and Cryptococcus species. Not detectable for Penicillium purpurescens and Blastomyces dermatitidis. Inconsistent for Hansenula anomala, Exophiala jeanseimelei, Actinomyces bovis, Rhodotorula rubra, Mucor ramosissimus at low inoculum.	(See Table 2 for detailed TTD)	Mixed results depending on the specific organism and inoculum level. The phrase "equivalent performance" might be an overarching claim, with noted exceptions.
Recovery of Mycobacteria (Internal)	Acceptable recovery and TTD compared to BACTEC 13A (implicitly).	Acceptable for a majority of tested species. Detection delays/compromised recovery for M. intracellulare, M. malmoense, M. haemophilum, M. xenopi with < 3 mL blood.	(See Table 3 for detailed TTD)	Generally acceptable, with specific limitations noted for low blood volumes.
False Positive Rate (Clinical)	Acceptable rate for a blood culture system (no explicit number given).	0.7% (11 out of 1,488 blood cultures)	Not directly compared to a predicate here.	Within expected range for such systems at the time.
False Negative Rate (Clinical)	Acceptable rate for a blood culture system (no explicit number given).	0.07% (1 out of 1,488 blood cultures)	Not directly compared to a predicate here.	Within expected range for such systems at the time.
Contamination Rate (Clinical)	Acceptable rate for a blood culture system (no explicit number given).	3.3%	Not directly compared to a predicate here.	Within expected range for such systems at the time.

Study Details

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

Clinical Studies (Test Set):
- Mycobacteria: 1,100 blood culture specimens.
- Yeast and Fungi (Blood): 748 blood culture specimens.
- Overall Clinical Evaluation (Mycobacteria, Yeast, Fungi, Other Bacteria): 1,488 blood cultures.
Internal Performance Studies (Test Set - In Vitro):
- Yeast and Fungi: A variety of species at different CFU levels (e.g., TNTC, 170, 16, 80, 6 CFU/vial) and specimen volumes (0 mL, 1 mL, 5 mL blood). Each value is the average of "all vials per test condition" (specific number of vials per condition not detailed).
- Mycobacteria: A variety of species at different CFU levels (e.g., 0, 1, 2, 3, 5, 7, 12, 13, 16, 20, 31, 44, 45, 49, 53, 58, 68 CFU/vial) and specimen volumes (1 mL, 3 mL, 5 mL blood). Two replicates ("Replicate" and original reading) are shown for each condition.
Data Provenance:
- Clinical Studies: Conducted at "two clinical sites considered large tertiary care teaching hospitals in geographically diverse areas" (for mycobacteria) and "four clinical sites considered large tertiary care teaching hospitals" (for fungi). Patient populations included HIV, immunocompromised, transplant patients, and those suspected of mycobacterial or fungal infections. This indicates prospective clinical data from diverse, real-world patient samples.
- Internal Performance Studies: Conducted by Becton Dickinson Microbiology Systems. These are retrospective/in-vitro laboratory studies using controlled inoculums of specific organism strains.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

The document does not explicitly state the number of experts or their specific qualifications (e.g., radiologists with X years of experience). However, for the clinical studies, ground truth was established by:

Determining the "total number of pathogenic mycobacteria isolates recovered" and "total number of pathogenic yeast and fungal isolates recovered" from the various culture media.
For false positive/negative rates, instrument results were compared to "smear and/or subculture-negative" or "smear and/or subculture-positive." This implies standard microbiological techniques and interpretation by laboratory professionals, rather than image interpretation by radiologists.

4. Adjudication method for the test set:

The document does not describe a formal adjudication method (like 2+1 or 3+1). The ground truth for the clinical studies appears to be based on the established clinical laboratory results from the two or four tertiary care hospitals involved, likely following standard diagnostic protocols of the time. For false positives/negatives, smear and/or subculture results served as the determinant.

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:

This is not applicable to this device. The BACTEC MYCO/F LYTIC system is a blood culture medium used with an automated instrument for microbial growth detection, not an AI-assisted diagnostic imaging device that involves "human readers" in the traditional sense of image interpretation. The comparison is between different culture media/systems and their ability to recover and detect microorganisms.

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

The BACTEC MYCO/F LYTIC is a culture medium used with an instrument (BACTEC 9000 Blood Culture Series). The instrument automates the detection of growth (based on oxygen metabolism), but the "algorithm only" concept usually refers to AI in image analysis or similar fields. The performance measured is that of the medium and instrument system in detecting growth. While automated, human intervention is still required for specimen collection, inoculation, and interpretation of positive results (e.g., Gram stain, subculture for identification). Therefore, it's a device-only performance rather than a standalone algorithm in the AI sense.

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

Clinical Studies: Ground truth was established by microbiological culture results from the comparative methods (BACTEC 13A, ISOLATOR™ System) and confirmed by subculture and/or smear for positive/negative determinations. For identifying pathogenic isolates, standard laboratory identification methods would have been used.
Internal Performance Studies: Ground truth was established by known inoculum levels of specific microbial strains (CFU/vial) in a controlled laboratory setting.

8. The sample size for the training set:

The document does not explicitly describe a "training set" in the context of machine learning. The studies are traditional clinical and internal performance evaluations demonstrating the device's efficacy and substantial equivalence.
The "Substantial Equivalence" section mentions "Internal and clinical studies demonstrated equivalent performance with all predicate devices," implying these studies were used to demonstrate performance rather than to "train" an algorithm.

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

As there's no explicitly defined "training set" in the AI/ML context, this question is not applicable in the sense of how an algorithm's ground truth was established by experts for training.
The "ground truth" for the overall evaluation involves the known presence/absence of microorganisms and their identification through standard microbiological laboratory procedures and controlled laboratory inoculations, as described in point 7.

Summary

{0}------------------------------------------------

JAN 28 1998

K970333

510/k) SUMMARY OF SAFETY AND EFFECTIVENESS

SUBMITTED BY: BECTON DICKINSON MICROBIOLOGY SYSTEMS 7 LOVETON CIRCLE SPARKS, MD 21152

CONTACT: Dennis R. Mertz, Manager of Regulatory Affairs

TELEPHONE: (410) 316-4099

FAX: (410) 316-4499

January 20, 1998 PREPARED:

DEVICE NAME: BACTEC MYCO/F LYTIC BLOOD CULTURE MEDIUM

DEVICE

CLASSIFICATION: Monitor, Microbial Growth, Class I

PREDICATE

BACTEC 13A MYCOBACTERIA CULTURE MEDIUM. BACTEC NR DEVICE: FUNGAL CULTURE MEDIUM, AND ISOLATOR™ SYSTEM

INTENDED USE:

MYCO/F LYTIC culture medium when used with the BACTEC 9000 Blood Culture Series of instruments is a non-selective culture medium to be used as an adjunct to aerobic blood culture media for the recovery of mycobacteria, yeast and fungi. This media may also be used for the culture of sterile body fluids when veast or fungi are suspected.

DEVICE DESCRIPTION:

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SUBSTANTIAL EQUIVALENCE:

Table 1 summarizes the similarities and differences between the BACTEC MYCO/F LYTIC culture medium and BACTEC 13A Mycobacteria culture medium and BACTEC NR FUNGAL culture medium. Internal and clinical studies demonstrated equivalent performance with all predicate devices.

INTERNAL PERFORMANCE

A study was conducted to evaluate the recovery and time to detection (TTD) of a variety of yeast and fungi species at different CFU levels and specimen volumes between BACTEC NR FUNGAL Culture medium and BACTEC MYCO/F LYTIC Culture medium. TABLE 2 shows the results of this study. The recovery of Histoplasma capsulatum and Malesezzia furfur with BACTEC MYCO/F LYTIC culture medium demonstrated improved recovery compared to the BACTEC NR FUNGAL Culture medium. Pencillium purpurescens and Blastomvees dermatitidis were not detectable in the BACTEC MYCO/F LYTIC culture medium. Hansenula anomala, Exophiala jeamselmei, Actinomvces bovis, Rhodotorula rubra, and Mucor ramosissimus exhibited inconsistent results at low inoculum levels (<10 CFU/vial) during this evaluation. For yeast, the recovery of various Candida and Cryptococcus species in the BACTEC MYCO/F LYTIC Culture medium was equivalent to the BACTEC NR FUNGAL Culture medium.

A study was conducted to evaluate the recovery and time to detection of a variety of mycobacteria at different CFU levels and specimen volumes with BACTEC MYCO/F LYTIC Culture medium. TABLE 3 shows the results of this study. Recovery of a majority of the tested mycobacteria species at the various CFU levels and specimen volumes was acceptable with BACTEC MYCO/F LYTIC Culture medium, although with less than 3 mL of blood, M. intracellulare, M. malmoense, M. haemophilum and M. xenopi exhibited detection delays and/or compromised recovery.

CLINICAL PERFORMANCE:

The BACTEC MYCO/F Lytic medium was evaluated with the BACTEC 9240 instrument at two clinical sites considered large tertiary care teaching hospitals in geographically diverse areas. The site populations included patients infected with HIV. immunocompromised patients. transplant patients, and patients suspected of a mycobacterial infection. The BACTEC MYCO/F Lytic medium was compared to the BACTEC 13A medium for the recovery and detection of mycobacteria from blood. A total of 1,100 blood culture specimens were tested during the evaluation. The total number of pathogenic mycobacteria isolates recovered in the study was 111 (See TABLE 4). Of these positives, ten (9%) were recovered in the BACTEC MYCO/F Lytic medium only and three (3%) were recovered by BACTEC 13A medium only.

{2}------------------------------------------------

Organism	TotalIsolates	Myco/F LyticMedium Only	13AMediumOnly	Both
All PathogenicMycobacteria:
Mycobacterium avium	108	10	3	95
Mycobacterium tuberculosis	2	0	0	2
Mycobacterium celatum	1	0	0	1
Total	111	10	3	98

T ABLE 4: SUMMARY OF MYCO/F LYTIC MEDIUM ISOLATE RECOVERY DURING CLINICAL TRIAL

The BACTEC MYCO/F LYTIC medium was evaluated with the BACTEC 9240 instrument at four clinical sites considered large tertiary care teaching hospitals. The site populations included patients infected with HIV, immunocompromised patients, transplant patients, and patients suspected of a fungal infection. The BACTEC MYCO/F LYTIC medium was compared to the ISOLATOR™ System (Wampole Laboratories, Cranbrook, NJ) for the recovery and detection of yeast and fungi from blood. MYCO/F LYTIC vials were inoculated with 1-5 mL of blood and ISOLATOR tubes were inoculated with 3-10 mL of blood. The ISOLATOR sediment was plated to Chocolate Agar, Brain Heart Infusion Agar with 5% sheep blood, and Sabaraud Dextrose Agar. A total of 748 specimens were tested during the evaluation. The total number of pathogenic yeast and fungal isolates recovered in the study was 32 (See TABLE 5). Of these positives, seven (22%) were recovered in the BACTEC MYCO/F LYTIC medium only and six (19%) were recovered in the ISOLATOR system only.

Organism	TotalIsolates	Myco/F LyticMedium Only	IsolatorOnly	Both
All Pathogenic Fungi:
Candida albicans	10	3	3	4
Candida glabrata	5	0	1	4
Candida krusei	2	2	0	0
Candida parapsilosis	1	1	0	0
Candida tropicalis	1	1	0	0
Cryptococcus neoformans	1	0	0	1
Fusarium species	1	0	1	0
Histoplasma capsulatum	11	0	1	10
Total	32	7	6	19

T ABLE 5: SUMMARY OF MYCOF LYTIC MEDIUM ISOLATE RECOVERY DURING CLINICAL TRIAL

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One thousand four hundred eighty-eight (1,488) blood cultures obtained from patients suspected of mycobacterial, yeast or fungal infections were evaluated in the BACTEC MYCO/F LYTIC culture vial with the BACTEC 9240 Blood Culture System. There were 315 positive cultures of which 243 had clinically significant organisms recovered, of which 131 (53.9%) were mycobacteria, 35 (14.4%) were yeast or fungi, and 77 (31.7%) were other bacteria. Of the 1,488 blood specimens tested in the clinical study, eleven BACTEC MYCO/F LYTIC culture vials (0.7%) were determined to be false positive (instrument-positive, smear and/or subculture-negative). Of the 315 instrument positive MYCO/F LYTIC vials, 11 (3.5%) were determined to be false positive. Of the 1,488 blood specimens tested in the clinical study, one (1) BACTEC MYCO/F LYTIC culture vial (0.07%) was determined to be false negative (instrument-negative, smear and/or subculture-positive). Of the 1,173 instrument negative BACTEC MYCO/F LYTIC culture vials, one (0.08%) was determined to be false negative. The contamination rate during this evaluation was 3.3%.

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	BACTEC MYCO/FLYTIC	BACTEC 13A	BACTEC NR FUNGAL
Intended Use	Qualitative culture andrecovery ofmycobacteria	Qualitative culture andrecovery ofmycobacteria	Qualitative culture andrecovery of yeast and fungi
Sample Type	Blood, unprocessed andother sterile body fluids	Blood, unprocessed	Blood, unprocessed
Sample Volume	1 - 5 mL	1 - 5 mL	3 - 10 mL
Blood to Broth Ratio	1 to 8	1 to 6	1 to 2.5
Growth Medium	Modified Middlebrook7H9 and enriched brainheart infusion broth	Modified Middlebrook7H9 broth	Enriched brain heart infusionbroth
Reactive ingredients:• Process water• Brain heart infusion• Soybean-Casein Digest• 7H9 Broth Base• Inositol• Casein Hydrolysate• Ferric Ammonium Citrate• Yeast Extract• Glycerol• Sodium Polysulfonate(SPS)• Sucrose• Tween 80(Polysorbate)• Saponin• L-Asparagine¹• Catalase• Antifoam Agent• Tobramycin• ¹⁴C Substrate• Potassium Phosphate• Pyridoxal HCL• Chloramphenicol• Dextrose	40mL0.5%w/v0.10%w/v0.12%w/v0.05%w/v0.10%w/v0.006%w/v----0.10%w/v0.025%w/v----0.0025%w/v0.24%w/v0.10%w/v----0.01%w/v--------0.024%w/v0.0001%w/v----0.10%w/v	30mL--------0.47%w/v----0.10%w/v------------0.025%w/v----0.02%w/v--------1440 units--------5µCi----------------	25mL1.0%w/v0.5%w/v----0.05%w/v----0.0001%w/v0.035%w/v----0.05%w/v0.6%w/v----0.24%w/v--------0.01%w/v0.001w/v------------0.005%w/v0.10%w/v
Supplement	None	BACTEC Enrichment	None
Instrument	BACTEC 9000 BloodCulture SeriesInstruments	BACTEC 460TB	BACTEC NR Systems
Growth Detection	O₂ metabolism	PalmitateDecarboxylation	CO₂ production
Incubation T/mixing	35°C ± 1.5°C;instrument agitation	37° C ± 1.5°C; noagitation	35° C ± 1.5°C; 48 hragitation
Type of Monitoring	Non-invasive,	Invasive vialheadspace sampling	Invasive vial headspacesampling

" ・"・

TABLE 1. Substantial Equivalence of BACTEC MYCO/F LYTIC Culture Medium to

BACTEC 13A and BACTEC 13A and BACTEC NR FUNGAL

(noted as Supplement H)

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Detection of fungi in Myco/F Lytic medium. Each value is the average of all vials per test condition. TABLE 2.

			Time to Detection (days)
			BACTEC 9000 Blood Culture			BACTEC NR Blood Culture
Organism	Strain	CFU/Vial	0 mL Blood	1 mL Blood	5 mL Blood	0 mL. Blood	1 mL Blood	5 ml. Blood
Hansenula anomala	580	TNTC	4.6	5.4	6.0	9.0	12.0	3.0
Hansenula anomala	580	170	8.4	7.0	6.7	3.0	6.5	3.5
Hansenula anomala	580	16	negative	negative	5.6	negative	negative	14.0
Exophiala jeansemelei	10224	TNTC	negative	11.1	12.1	12.0	12.0	12.0
Exophiala jeansemelei	10224	80	29.6	19.3	14.1	23.0	12.0	12.0
Exophiala jeansemelei	10224	6	negative	negative	25.9	29.0	14.0	16.0
Penicillium purpurescens	10485	35.5	4.1	negative	negative	negative	negative	negative
Penicillium purpurescens	10485	4.5	negative	negative	negative	negative	negative	negative
Penicillium purpurescens	10485	0	negative	negative	negative	negative	negative	negative
Aspergillis fumigatus	13073	TNTC	0.8	0.7	0.6	1.5	1.5	1.0
Aspergillis fumigatus	13073	63	1.2	0.7	0.7	1.5	2.3	1.0
Aspergillis fumigatus	13073	9.5	1.3	0.9	0.9	3.0	3.0	1.5
Actinomyces bovis	13683	14.5	2.4	1.6	1.6	2.0	1.5	1.5
Actinomyces bovis	13683	1.5	3.3	2.5	2.3	3.0	2.5	2.5
Actinomyces bovis	13683	0	negative	4.1	3.0	negative	negative	negative
Histoplasma capsulatum	16585	TNTC	0.9	1.0	0.9	negative	negative	negative
Histoplasma capsulatum	16585	61	1.0	1.0	0.9	negative	negative	negative
Histoplasma capsulatum	16585	6.5	1.1	1.1	0.9	negative	negative	negative
Aspergillis flavus	16883	TNTC	1.0	1.0	0.9	1.5	1.5	1.5
Aspergillis flavus	16883	145.5	2.0	1.2	1.6	3.0	1.5	1.5
Aspergillis flavus	16883	23.5	2.5	1.6	1.3	3.0	2.5	1.5
Ajellomyces dermatitidis	18187	42	1.1	0.9	0.9	3.0	3.0	1.5
Ajellomyces dermatitidis	18187	10.5	1.3	0.9	1.0	3.0	3.0	1.5
Ajellomyces dermatitidis	18187	0.5	1.3	1.3	1.1	3.5	3.0	3.0
Nocardia asteroides	18187	234	1.1	1.0	1.0	3.0	1.8	1.8
Nocardia asteroides	18187	28	2.9	2.1	1.5	3.0	3.0	2.0
Nocardia asteroides	18187	2.5	4.1	3.7	3.3	negative	negative	9.5
Rhodotorula rubra	18803	TNTC	7.8	5.9	4.2	3.0	3.0	3.0
Rhodotorula rubra	18803	100	23.4	11.9	15.8	5.5	4.0	4.0
Rhodotorula rubra	18803	8	negative	3.2	negative	12.0	9.5	5.0
			Time to Detection (days)
			BACTEC 9000 Blood Culture			BACTEC NR Blood Culture
Organism	Strain	CFU/Vial	0 mL Blood	1 mL Blood	5 mL Blood	0 mL Blood	1 mL Blood	5 mL Blood
Trichophyton rubrum	18803	131.5	9.6	4.0	3.9	13.0	4.0	4.0
Trichophyton rubrum	18803	10.5	12.5	4.5	4.3	13.0	4.0	4.0
Trichophyton rubrum	18803	0.5	10.9	6.6	6.2	19.0	5.0	5.0
Mucor ramosissimus	18803	85.5	18.7	4.8	3.1	6.0	4.0	3.0
Mucor ramosissimus	18803	13.5	11.3	5.4	4.3	negative	15.5	12.0
Mucor ramosissimus	18803	2	negative	negative	negative	negative	21.0	19.0
Malesezzia furfur	19247	TNTC	0.6	0.6	0.6	13.0	negative	negative
Malesezzia furfur	19247	231	2.0	0.6	0.6	3.0	negative	negative
Malesezzia furfur	19247	22.5	0.7	0.6	0.7	negative	negative	negative
Blastomyces dermatitidis	19247	40.5	negative	24.1	24.1	negative	negative	23.0
Blastomyces dermatitidis	19247	3	negative	negative	negative	negative	negative	30.0
Blastomyces dermatitidis	19247	0	negative	negative	negative	negative	negative	negative
Average			6.8	4.6	4.5	7.4	6.0	7.7

. :・

TNTC: Too Numerous to Count negative: At least one vial negative at the end of protocol

. . '

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T ABLE 2 Detection of fungi in MycolF Lytic medium. Each value is the average of all vials per test condition.

TNTC: Too Numerous to Count negative: At least one vial negative at the end of protocol

{7}------------------------------------------------

TABLE 3 .Time to Detection of Mycobacteria in the Myco/F Lytic Medium.

	strain	cfu/bottle	1 mL blood	3 mL blood	5 mL blood
M. tuberculosis	582	0, 0	16.8	16.8	14.2
Replicate			neg	16.8	neg
Average			16.8	16.8	14.2
M. avium	2638	49, 45	8.1	8.1	8.1
Replicate			8.1	7.8	8.1
Average			8.1	8.0	8.1
M. intracellulare	2792	80, 44	21.5	10.8	10.1
Replicate			neg	10.5	9.8
Average			21.5	10.7	10.0
M. fortuitum	3072	5, 0	5.5	4.4	4.3
Replicate			5.8	4.4	3.9
Average			5.7	4.4	4.1
M. bovis	2003	12, 13	19.8	20.5	19.1
Replicate			20.8	19.5	19.5
Average			20.3	20.0	19.3
M. kansasii	2205	7, 3	13.1	12.5	15.8
Replicate			12.1	13.5	14.1
Average			12.6	13.0	15.0
M. terrae	3001	0, 0	13.8	18.5	9.5
Replicate			12.5	neg	12.7
Average			13.2	18.5	11.1
M. szulgai	2353	1, 2	25.5	22.8	19.1
Replicate			22.5	neg	neg
Average			24.0	22.8	19.1
M. simiae	2304	68, 58	7.0	7.4	7.4
Replicate			6.9	7.4	7.3
Average			7.0	7.4	7.4
M. gordonae	2454	2, 5	28.2	31.2	neg
Replicate			30.8	28.8	29.5
Average			29.5	30.0	29.5
M. celatum	3661	53, 31	13.1	10.8	10.8
Replicate			13.1	10.5	10.8
Average			13.1	10.7	10.8
M. abscessus	3370	1, 0	4.1	neg	neg
Replicate			4.3	4.0	3.6
Average			4.2	4.0	3.6
M. malmoense	3472	16, 20	24.8	10.8	10.4
Replicate			25.3	10.4	10.4
Average			25.1	10.6	10.4
M. haemophilum	5121	1, 1	neg	23.2	19.8
Replicate			35.9	23.5	17.2
Average			35.9	23.4	18.5
M. xenopi	3052	0, 0	neg	42.9	40.2
Replicate			neg	34.5	40.9
Average			neg	38.7	40.6
C. neoformans	13690	13, 31	2.8	2.5	2.8
Replicate			2.7	2.7	2.9
Average			2.8	2.6	2.9

-. • • • • • •

ﺎ

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Image /page/8/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is a stylized eagle or bird-like symbol with three distinct segments forming its body and wings. The logo is black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 2 8 1998

Mr. Dennis R. Mertz Manager, Regulatory Affairs Becton Dickinson Microbiology Systems 7 Loveton Circle Sparks, Maryland 21152-0999

Re: K970333

Trade Name: BACTEC® Myco/F Lytic Culture Vials Regulatory Class: I Product Code: MDB Dated: October 24, 1997 Received: October 27, 1997

Dear Mr. Mertz:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify. such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours.

Steven Autman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS STATEMENT

510(k) Number K970333

Device Name: BACTEC® MYCO/F LYTIC Culture Vials

Indication for Use:

Per 21 CFR 801.109

(Please do not WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)	V.Am Tichurt MD Interim Ch. of, Microbiol Pr
Division of Clinical Laboratory Devices
510(k) Number	__________________________

Prescription Use	✓	OR	Over-The-Counter Use	__________________________
------------------	--------------------------------------	----	----------------------	----------------------------

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.