← Product Code [MDB](/submissions/MI/subpart-c%E2%80%94microbiology-devices/MDB) · K970333

# BACTEC MYCO/F LYTIC CULTURE VIALS (K970333)

_Becton Dickinson Microbiology Systems · MDB · Jan 28, 1998 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/MDB/K970333

## Device Facts

- **Applicant:** Becton Dickinson Microbiology Systems
- **Product Code:** [MDB](/submissions/MI/subpart-c%E2%80%94microbiology-devices/MDB.md)
- **Decision Date:** Jan 28, 1998
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.2560
- **Device Class:** Class 1
- **Review Panel:** Microbiology

## Indications for Use

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 Story

BACTEC MYCO/F LYTIC culture medium is a specialized broth (Middlebrook 7H9 and Brain Heart Infusion) for recovery of mycobacteria, yeast, and fungi from blood and sterile body fluids. Vials contain a sensor detecting oxygen concentration decreases caused by microbial metabolism; BACTEC 9000 series instruments monitor this via increasing fluorescence. Used in clinical laboratories; operated by technicians. Provides presumptive positive determination for viable microorganisms. Benefits patients by enabling detection of slow-growing pathogens, aiding clinical diagnosis of septicemia.

## Clinical Evidence

Clinical evaluation at tertiary care teaching hospitals compared BACTEC MYCO/F LYTIC medium to BACTEC 13A (n=1,100) and ISOLATOR system (n=748). For mycobacteria, 111 pathogenic isolates recovered; 10 (9%) in subject medium only, 3 (3%) in 13A only. For fungi, 32 pathogenic isolates recovered; 7 (22%) in subject medium only, 6 (19%) in ISOLATOR only. Overall study (n=1,488) showed 0.7% false positive rate and 0.07% false negative rate.

## Technological Characteristics

Modified Middlebrook 7H9 and Brain Heart Infusion broth. Contains saponin (lysing agent), ferric ammonium citrate (iron source), proteins, and sugars. Employs non-invasive fluorescent sensor technology to detect oxygen depletion. Dimensions/form factor: culture vial. Connectivity: BACTEC 9000 series instrument integration. Sterilization: Not specified.

## Regulatory 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.

## Predicate Devices

- BACTEC 13A MYCOBACTERIA CULTURE MEDIUM
- BACTEC NR FUNGAL CULTURE MEDIUM
- ISOLATOR™ SYSTEM

## Submission Summary (Full Text)

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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

PREPARED: January 20, 1998

DEVICE NAME: BACTEC MYCO/F LYTIC BLOOD CULTURE MEDIUM

DEVICE CLASSIFICATION: Monitor, Microbial Growth, Class I

PREDICATE DEVICE: BACTEC 13A MYCOBACTERIA CULTURE MEDIUM, BACTEC NR 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 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 yeast 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, yeast, 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 metabolism 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.

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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 *Blastomyces dermatitidis* were not detectable in the BACTEC MYCO/F LYTIC culture medium. *Hansenula anomala*, *Exophiala jeamselmei*, *Actinomyces 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.

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

|  Organism | Total Isolates | Myco/F Lytic Medium Only | 13A Medium Only | 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  |

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.

TABLE 5: SUMMARY OF MYCO/F LYTIC MEDIUM ISOLATE RECOVERY DURING CLINICAL TRIAL

|  Organism | Total Isolates | Myco/F Lytic Medium Only | Isolator Only | 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  |

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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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TABLE 1. Substantial Equivalence of BACTEC MYCO/F LYTIC Culture Medium to BACTEC 13A and BACTEC NR FUNGAL

|   | BACTEC MYCO/F LYTIC | BACTEC 13A | BACTEC NR FUNGAL  |
| --- | --- | --- | --- |
|  Intended Use | Qualitative culture and recovery of mycobacteria | Qualitative culture and recovery of mycobacteria | Qualitative culture and recovery of yeast and fungi  |
|  Sample Type | Blood, unprocessed and other steile 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 Middlebrook 7H9 and enriched brain heart infusion broth | Modified Middlebrook 7H9 broth | Enriched brain heart infusion broth  |
|  Reactive ingredients: |  |  |   |
|  • Process water | 40mL | 30mL | 25mL  |
|  • Brain heart infusion | 0.5%w/v | --- | 1.0%w/v  |
|  • Soybean-Casein Digest | 0.10%w/v | --- | 0.5%w/v  |
|  • 7H9 Broth Base | 0.12%w/v | 0.47%w/v | ---  |
|  • Inositol | 0.05%w/v | --- | 0.05%w/v  |
|  • Casein Hydrolysate | 0.10%w/v | 0.10%w/v | ---  |
|  • Ferric Ammonium Citrate | 0.006%w/v | --- | 0.0001%w/v  |
|  • Yeast Extract | --- | --- | 0.035%w/v  |
|  • Glycerol | 0.10%w/v | --- | ---  |
|  • Sodium Polysulfonate(SPS) | 0.025%w/v | 0.025%w/v | 0.05%w/v  |
|  • Sucrose | --- | --- | 0.6%w/v  |
|  • Tween 80(Polysorbate) | 0.0025%w/v | 0.02%w/v | ---  |
|  • Saponin | 0.24%w/v | --- | 0.24%w/v  |
|  • L-Asparagine¹ | 0.10%w/v | --- | ---  |
|  • Catalase | --- | 1440 units | ---  |
|  • Antifoam Agent | 0.01%w/v | --- | 0.01%w/v  |
|  • Tobramycin | --- | --- | 0.001w/v  |
|  • ¹⁴C Substrate | --- | 5μCi | ---  |
|  • Potassium Phosphate | 0.024%w/v | --- | ---  |
|  • Pyridoxal HCL | 0.0001%w/v | --- | ---  |
|  • Chloramphenicol | --- | --- | 0.005%w/v  |
|  • Dextrose | 0.10%w/v | --- | 0.10%w/v  |
|  Supplement | None | BACTEC Enrichment | None  |
|  Instrument | BACTEC 9000 Blood Culture Series Instruments | BACTEC 460TB | BACTEC NR Systems  |
|  Growth Detection | O₂ metabolism | Palmitate Decarboxylation | CO₂ production  |
|  Incubation T°/mixing | 35°C ± 1.5°C; instrument agitation | 37°C ± 1.5°C; no agitation | 35°C ± 1.5°C; 48 hr agitation  |
|  Type of Monitoring | Non-invasive, fluorescent detection | Invasive vial headspace sampling | Invasive vial headspace sampling  |

(noted as Supplement H)

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

|  Organism | Strain | CFU/Vial | BACTEC 9000 Blood Culture |   |   | BACTEC NR Blood Culture  |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   |   |   |  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  |
|  Aspergillus fumigatus | 13073 | TNTC | 0.8 | 0.7 | 0.6 | 1.5 | 1.5 | 1.0  |
|  Aspergillus fumigatus | 13073 | 63 | 1.2 | 0.7 | 0.7 | 1.5 | 2.3 | 1.0  |
|  Aspergillus 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  |
|  Aspergillus flavus | 16883 | TNTC | 1.0 | 1.0 | 0.9 | 1.5 | 1.5 | 1.5  |
|  Aspergillus flavus | 16883 | 145.5 | 2.0 | 1.2 | 1.6 | 3.0 | 1.5 | 1.5  |
|  Aspergillus 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  |

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

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

|  Organism | Strain | CFU/Vial | Time to Detection (days)  |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   |   |   |  BACTEC 9000 Blood Culture |   |   | BACTEC NR Blood Culture  |   |   |
|   |   |   |  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  |
|  Malasezzia furfur | 19247 | TNTC | 0.6 | 0.6 | 0.6 | 13.0 | negative | negative  |
|  Malasezzia furfur | 19247 | 231 | 2.0 | 0.6 | 0.6 | 3.0 | negative | negative  |
|  Malasezzia 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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TABLE 3. Time to Detection of Mycobacteria in the Myco/F Lytic Medium.

|   | strain | cfu/bottle | BACTEC 9000 Blood Culture (Days)  |   |   |
| --- | --- | --- | --- | --- | --- |
|   |  |  | 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  |

{8}

DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
2098 Gaither Road
Rockville MD 20850

JAN 28 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 (QS) 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.

{9}

Page 2

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

Enclosure

{10}

JAN 15 '98 17:08 FROM BDMS REGULATORY TO FDA DCLD PAGE.010/013

# INDICATIONS STATEMENT

510(k) Number K970333

**Device Name:** BACTEC® MYCO/F LYTIC Culture Vials

**Indication for Use:**

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.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Intern. Ch. of Microbiology
Division of Clinical Laboratory Devices
510(k) Number _______________

Prescription Use ☑
Per 21 CFR 801.109

OR

Over-The-Counter Use____

---

**Source:** [https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/MDB/K970333](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/MDB/K970333)

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