(122 days)
The BACTEC® MGIT™ 960 System is an instrumented system using a modified 7H9 growth medium for the detection of using a modifical specimens (except blood).
The BACTEC® MGIT™ 960 System is an in vitro diagnostic instrument designed and optimized for the rapid detection of mycobacterial and incouleted into RRI optimized for the rapid delection of informations processed and inoculated into BBL® and urine). Samples are collected from patients, processed and inoculation in CRBL® MGIT and urine). Samples are collected iront patients, procobod and incolance in the mail. MGIT™ 7mL tubes supplemented with BBL® MGIT™ and BBL® MGIT™ OADC.
The BACTEC® MGIT™ 960 instrument is a self-contained incubation/detection unit which contains three drawers; each drawer holding up to 320 tubes of growth medium containing fluorescent indicator. Inoculated tubes are monitored by the instrument continuously for growth, based on the detection of fluorescence. Mycobacteria matabolize nutrients and oxygen in the BBL" MGIT™ culture broth. The MGIT tubes contain a fluorescent indicator which reacts to the concentration of oxygen in the culture medium. As the microorganisms use the oxygen, the indicator begins to fluoresce when exposed to excitation light. The BACTEC® MGTT™ 960 instrument's photo detectors measure the level of fluorescence, which corresponds to microorganism growth. Clinical specimens (except blood) are collected from patients and processed, when necessary, using standard digestion/decontamination procedures. Specimens are inoculated (0.5 ml) into propared MGIT tubes (with MGIT OADC and MGIT PANTA. if necessary) and entered into the BACTEC® MGIT™ 960 System. All tubes entered into the system are read every sixty minutes. When a MOIT tube is detected as positive, the positive tube inclument for confirmation by front. Positive MGIT tubes are removed from the instrument for confirmation by acid-fast bacilli (AFB) smeal, foolation and feeniness and of protocol, the negative tubes are removed and discarded.
The BACTEC® MGIT™ 960 System is intended for the rapid detection of mycobacteria from clinical specimens (excluding blood and urine). The system uses fluorescent detection of oxygen consumption by microorganism growth in specially prepared MGIT tubes.
Here's a breakdown of the acceptance criteria and the study that demonstrates the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state quantitative acceptance criteria in a structured table. However, the study aims to demonstrate substantial equivalence to existing predicate devices (BACTEC® 460TB System and Conventional Media). The performance metrics presented are recovery rates and false positive/negative rates, allowing for comparison.
| Performance Metric | BACTEC® MGIT™ 960 System Performance | BACTEC® 460TB System Performance (Predicate) | Conventional Media Performance (Predicate) |
|---|---|---|---|
| Mycobacterial Recovery Rate | 80% (289/362 isolates) | 75% (271/362 isolates) | 69% (250/362 isolates) |
| False Positive Rate (Instrument) | 0.8% (27/3330 specimens) | Not explicitly stated for 460TB | Not explicitly stated for conventional |
| False Positive Rate (Positive Tubes) | 8.6% (27/313 positive MGIT tubes) | Not explicitly stated for 460TB | Not explicitly stated for conventional |
| False Negative Rate (Instrument) | 0% (based on terminal subcultures) | Not explicitly stated for 460TB | Not explicitly stated for conventional |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: A total of 3330 specimens were tested during the external evaluation study.
- Data Provenance: The study was an external evaluation performed at six (6) sites. The country of origin is not explicitly stated, but given the submission to the US FDA, it is highly likely that these sites were in the United States. The study appears to be prospective as clinical specimens were "tested during the study" in a comparative manner.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number of experts or their qualifications for establishing the ground truth. It states that "positive MGIT tubes are removed from the instrument for confirmation by acid-fast bacilli (AFB) smear, isolation and identification." This implies that trained laboratory personnel or microbiologists performed these confirmatory tests, which serve as the ground truth. However, specific expert qualifications are not detailed.
4. Adjudication Method for the Test Set
The document does not describe a formal "adjudication method" in terms of multiple expert reviews and reconciliation for the ground truth. Instead, confirmation of positive MGIT tubes was done through standard microbiological procedures (AFB smear, isolation, and identification). For "false positive" determinations for the MGIT 960, 27 tubes were found to be instrument-positive but negative by smear and/or subculture. For "false negative" determinations, terminal subcultures of approximately 15% of instrument-negative tubes were performed to confirm the absence of growth. This suggests a direct comparison to laboratory reference methods rather than an expert consensus adjudication process.
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. The BACTEC® MGIT™ 960 System is an automated instrument for detecting microbial growth, not an AI system designed to assist human readers in image interpretation or diagnosis. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or is relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the study primarily evaluates the standalone performance of the BACTEC® MGIT™ 960 System. The instrument itself detects fluorescence indicating growth. While subsequent manual confirmatory tests (AFB smear, isolation, identification) are performed on positive samples, the initial detection is performed solely by the algorithm/instrument without human intervention. The reported recovery rates and false positive/negative rates directly reflect the instrument's standalone performance in detecting mycobacterial growth.
7. The Type of Ground Truth Used
The ground truth used in this study was based on standard microbiological laboratory methods:
- For positive identification: Acid-fast bacilli (AFB) smear, isolation, and identification from positive MGIT tubes.
- For confirming negative status: Terminal subcultures of instrument-negative tubes.
These methods represent a combination of direct observation (smear) and culture-based growth as definitive evidence of mycobacterial presence or absence.
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of machine learning. The BACTEC® MGIT™ 960 System is a device for detecting growth based on an optical sensor and algorithm, not a learning-based AI model that requires a distinct training phase with a labeled dataset in the conventional sense. The development of the detection algorithm would have involved internal validation and calibration with various mycobacterial and non-mycobacterial samples, but this is not specified as a formal "training set" in the document.
9. How the Ground Truth for the Training Set Was Established
As noted above, a formal "training set" and associated ground truth establishment for a machine learning model is not applicable here. The "training" or calibration of the instrument's detection algorithm would have been part of its internal development and validation, likely using well-characterized mycobacterial cultures and clinical samples confirmed by standard laboratory methods. However, the document does not provide details on this process.
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Bactor: Dickinson Microbiology Systems . 51 . 14 ........ , mks Marc and 2015, 09:09 1. J : - 1 -
MAY 1 1998
K974/883
Image /page/0/Picture/3 description: The image shows the logo for Becton Dickinson. The logo is in black and white, with the words "BECTON" stacked on top of "DICKINSON". The text is bolded and slightly slanted to the right. The logo is simple and recognizable.
APPENDIX L
SUMMARY OF SAFETY & EFFICACY
SUBMITTED BY: BECTON DICKINSON MICROBIOLOGY SYSTEMS
CONSULTION CHITON OIDSLE 7 LOVETON CIRCLE SPARKS, MD 21152
- Jody J. Hoffmann, Regulatory Affairs Associate CONTACT: (410)316-4546 TELEPHONE:
- DECEMBER 29, 1997 PREPARED:
- BACTEC® MGIT™ 960 System DEVICE NAME:
PREDICATE
- BACTEC® 460 TB System DEVICES: Conventional Media
- INTENDED USE: The BACTEC® MGIT™ 960 System is an instrumented system using a modified 7H9 growth medium for the detection of using a modifical specimens (except blood).
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DEVICE DESCRIPTION:
The BACTEC® MGIT™ 960 instrument is a self-contained incubation/detection unit The BACTEC" MGIT™ 960 instrument is a sell-contaction in 320 tubes of growth
which contains three drawers; each drawer holding up to 320 tubes are monitored by t which containing fluorescent indicator. Inoculated tubes are monitored by the
medium containing fluorescent indicator. Incoulated tubes are monitored by the medium containing fluorescent indicator. Thocalatou table are works.
instrument continuously for growth, based on the detection of fluorescence.
Mycobacteria matabolize nutrients and oxygen in the BBL" MGIT™ culture broth.
The concentration the collected and indicator which reacts to the concentration Mycobacteria metabolize nutrients and oxygern in the CDC "Arch" - Concentration of
The MGIT tubes contain a fluorescent indicator which reacts to the concentration of The MGIT tubes contain a nucrescent microorganisms use the oxygen, the indicator
oxygen in the culture medium. As the microorganisms use the oxygen, the indication oxygen in the culture medium. As the microsonce The BACTEC® MGTT™ 960
begins to fluoresce when exposed to excitation light. The BACTEC® MGTT™ 960 begins to fluoresce when exposed to excitation light. "The arresponds
instrument's photo detectors measure the level of fluorescence, which corresponds to microorganism growth.
Clinical specimens (except blood) are collected from patients and processed, when Clinical specimens (except biogetion/decontamination procedures. Specimens are
necessary, using standard digestion/decontamination procedures. Specimens are necessary, using standard digestion online of Probection of OADC and MGIT PANTA.
inoculated (0.5 ml) into propared MGIT tubes (with MGIT OADC and MGIT PANTA. inoculated (0.5 ml) into propared MON table MGIT™ 960 System.
if necessary) and entered into the BACTEC® MGIT™ 960 System.
All tubes entered into the system are read every sixty minutes. When a MOIT tube All tubes entered into the system are read overy also his activated on the drawer
is detected as positive, the positive tube inclument for confirmation by is detected as positive, the positive table instrument for confirmation by
front. Positive MGIT tubes are removed from the instrument for confirmation by front. Positive MGTT (ubes are rentisved normalion. Negative MGTT tubes acid-fast bacilli (AFB) smeal, foolation and feeniness and of protocol, the negative tubes are removed and discarded.
DEVICE TECHNOLOGICAL CHARACTERISTICS:
Tables 1 through 3 summarize the similarities and differences between the BACTEC® MGIT™ 960 System and the predicate devices.
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BACTEC® MGIT™ 960 System versus BACTEC® 460TB System Table 1:
| Intended Use | Growth and detection of mycobacteriafrom clinical specimens, except blood. | Growth and detection of mycobacteriafrom clinical specimens. | ||
|---|---|---|---|---|
| Sample type | Respiratory and other body fluids. | Respiratory and other body fluids. | ||
| Sample volume | 0.5 mL | 0.5 to 1.0 mL | ||
| Growth medium | 7H9 Middlebrook broth base withnutrient additives. | 7H12 Middlebrook broth base withnutrient additives. | ||
| APPROX. COMPOSITION/1000 mL | APPROX. COMPOSITION/1000 mL | |||
| Growth Mediumingredients | Disodium phosphate | $2.5 g$ | Disodium phosphate | $2.5 g$ |
| L-Asparagine | 1.25 | |||
| Monopotassium phosphate | 1.0 | Monopotassium phosphate | 1.0 | |
| Sodium glutamate | 0.5 | Sodium glutamate | 0.5 | |
| Ammonium sulfate | 0.5 | Ammonium sulfate | 0.5 | |
| Sodium citrate | 0.1 | Sodium citrate | 0.1 | |
| Magnesium sulfate | 0.05 | Magnesium sulfate | 0.05 | |
| Ferric ammonium citrate | 0.04 | Ferric ammonium citrate | 0.04 | |
| Copper sulfate | 1.0 mg | Copper sulfate | 1.0 mg | |
| Pyridoxine | 1.0 | Pyridoxine | 1.0 | |
| Zinc sulfate | 1.0 | Zinc sulfate | 1.0 | |
| Biotin | 0.5 | Biotin | 0.5 | |
| Calcium chloride | 0.5 | Calcium chloride | 0.5 | |
| Casein peptone | $1.25 g$ | |||
| Glycerol | $3.1 mL$ | |||
| Casein hydrolysate | $0.1 g$ | |||
| Additional MediumGrowth Factors | BBL™ MGIT™ OADC enrichment:Oleic Acid, Albumin, Dextrose,Catalase | Albumin, Catalase | ||
| AntimicrobialSupplement | BBL™ MGIT™ PANTA™antibiotic mixture:polymixin B, amphotericin B, nalidixicacid, trimethoprim & azlocillin. | BACTEC™ PANTA™ PLUS:Polymixin B, amphotericin B, nalidixicacid, trimethoprim & azlocillin. | ||
| Growth detection | Fluorescent detection of O₂consumption by microorganismgrowth. | Radiometric detection of CO₂ liberatedby microorganism growth. | ||
| Incubation temp. | Instrument incubation at 37±1.5° C. | 35 ± 2° C. | ||
| Detector | O₂ sensitive fluorescent sensor insilicone rubber base. | 14C labeled fatty acid present in themedium. |
98
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| Intended Use | Growth and detection of mycobacteria from clinical specimens, except blood. | Used for the cultivation of Mycobacterium tuberculosis and other mycobacterial species. |
|---|---|---|
| Sample type | Respiratory and other body fluids. | Respiratory and other body fluids. |
| Sample volume | 0.5 mL | 0.1 to 0.5 mL |
| Growth Medium Ingredients | APPROX. COMPOSITION/1000 mL | APPROX. COMPOSITION/1000 mL |
| Disodium phosphate $2.5$ gL-Asparagine $1.25$Monopotassium phosphate $1.0$Sodium glutamate $0.5$Ammonium sulfate $0.5$Sodium citrate $0.1$Magnesium sulfate $0.05$Ferric ammonium citrate $0.04$Copper sulfate $1.0$ mgPyridoxine $1.0$Zinc sulfate $1.0$Biotin $0.5$Calcium chloride $0.5$Casein Peptone $1.25$ gGlycerol $3.1$ mL | L-Asparagine $6.0$ gMonopotassium phosphate $4.2$Sodium citrate $1.0$Magnesium sulfate $0.4$Glycerol $20.0$ mLPotato flour $50.0$ gMalachite green $0.67$Whole egg $1667.0$ mL | |
| Additional Medium Growth Factors | BBL TM MGITTM OADC enrichment:Oleic Acid, Albumin, Dextrose, Catalase | None |
| Antimicrobial supplement | Polymixin B, amphotericin B, nalidixic acid, trimethoprim & azlocillin (PANTA). | None |
| Detector | Fluorescent indicator in silicone rubber base. | None |
| Growth detection | Fluorescent detection of O2 consumption by microorganism growth. | Macroscopic observance of microorganism growth on medium surface. |
| Incubation temp. | Instrument Incubation at 37±1.5° C. | 35 ± 2° C. |
BACTEC® MGIT™ 960 System versus Lowenstein-Jensen media Table 2:
20 325
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BACTEC® MGIT™ 960 System versus Middlebrook 7H11/7H11-S Table 3:
| Used for the isolation and cultivation of | ||||
|---|---|---|---|---|
| Intended Use | Growth and detection of mycobacteria | mycobacteria. | ||
| from clinical specimens, except blood. | Respiratory and other body fluids. | |||
| Sample type | Respiratory and other body fluids. | 0.1 to 0.5 mL | ||
| Sample volumeGrowth Medium | 0.5 mLAPPROX. COMPOSITION/1000 mL | APPROX. COMPOSITION/1000 mL | ||
| Ingredients | Disodium phosphate | 2.5 g | Disodium phosphate | 1.5 g |
| L-Asparagine | 1.25 | L-Asparagine | 3.6 | |
| Monopotassium phosphate | 1.0 | Monopotassium phosphate | 1.5 | |
| Sodium glutamate | 0.5 | Sodium glutamate | 0.5 | |
| Ammonium sulfate | 0.5 | Ammonium sulfate | 0.5 | |
| Sodium citrate | 0.1 | Sodium citrate | 0.4 | |
| Magnesium sulfate | 0.05 | Magnesium sulfate | 0.05 | |
| Ferric ammonium citrate | 0.04 | Ferric ammonium citrate | 0.04 | |
| Copper sulfate | 1.0 mg | Copper sulfate | 1.0 mg | |
| Pyridoxine | 1.0 | Pyridoxine | 1.0 | |
| Zinc sulfate | 1.0 | Zinc sulfate | 1.0 | |
| Biotin | 0.5 | Biotin | 0.5 | |
| Calcium chloride | 0.5 | Calcium chloride | 0.5 | |
| Casein peptone | 1.25 g | |||
| Glycerol | 3.1 mL | Glycerol | 5.0 mL | |
| Oleic acid | 0.06 | |||
| Agar | 13.5g | |||
| Bovine albumin V | 5.0 | |||
| Dextrose | 2.0 | |||
| Sodium chloride | 0.85 | |||
| Pancreatic digest of casein | 1.0 | |||
| Catalase | 3.0 mg | |||
| Malachite green | 0.4 |
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SUMMARY OF DEVICE TESTING:
Internal testing of the BACTEC® MGIT™ 960 System demonstrated the ability to testing Internal testing of the BAC LEC MIST - 900 oy Additionally, internal testing
recover a wide variety of mycobacteria species. Addit m 960 System an recover a wide variety of mycobacteria species: "Addisonary, materials and the BACTEC® 460TB System.
An external evaluation was performed at six (6) sites. All sites used the BACTEC®
Comparison in the supportions! media et reference mathods for comparison to the An external evaluation was percorned at six (0) sites. An external to the comparison to the 460TB System and conventional media at forchise more tested during the
BACTEC® MGIT™ 960 System. A total of 3330 speciments were tested during the study. A total of 353 specimens were positive which represented 362 isolates
study. A total of 353 specimens were positive which represented 362 isolates study. A total of 353 speciments were positives by speciment type is:
recovered during the study. The distribution of positives by speciment bone mari recovered during the study. The distribution of position of the stool (0.85%) and bone marrow (0.65%).
Of the 362 isolates, 289 (80%) were recovered by the BACTEC® MGTT™ 960 Of the 362 isolates, 289 (80%) were recovered by the BACTE System and 250 (69%)
System, 271 (75%) were recovered by the BACTEC® 460TB System and 250 (69%) System, 271 (75%) were recovered by the USD for energined to be false in the were recovered by conventional solle more determined to be false positive
clinical study, 27 (0.8%) MGIT 960 tubes were determined to be false positive clinical study, 27 (0.0%) MGT 900 tubes word on the 313 MGTT 960 ( instrument positive tubes, 27 (8.6%) were determined to be false positive. The false positive, The false positive) was negative rate (instrument-negative, smear and/or subculture-positive) was negative rate (instrument-riegative, sincer and subcultures of ~ 15% of instrument determined to be 0% based on tellinial subcaltaros of the BACTEC® MGIT™ 960 System was 0.9%.
CONCLUSIONS:
Based on the internal and external evaluation of the BACTEC® MGIT™ 960 System,
14 the Based on the internal and external ST2C MGTT" 960 System is comparable to the BACTEC® 460TB System and conventional media; therefore, we believe the BACTEC® 4601B System to be substantially equivalent to these devices.
8 The term "substantial equivalence" as used in this 510(k) notification is imitied to the definition of substantial equivalence as found in the Federal Food, Drive and Cosmetic Act, as amended and as substantial equivalence as found in the rooming a device can be marketed without pro-market without pro-market in applied under 21 CFR 807, Subpan E division of substantial equivalency under this notincent survention is not approval of reclassification. A determination of patent infringement suits or any other intention in have any beling whaled to, or in support of substantial equivalence herein shall be
patent matters. No statements related to, or in support of substantial equiv patent matters. No statements related to, of in support of Subclanner of the application by the courts.
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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the bird figure.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
વિવેત્ક -MAY
Jody J. Hoffmann Regulatory Affairs Associate Becton Dickinson Becton Dickinson Microbiology Systems P.O. Box 999 Sparks, Maryland 21152-0999
K974883 Re:
Trade Name: Bactec® MGIT™ 960 System Regulatory Class: I Product Code: MDB Dated: April 15, 1998 Received: April 16, 1998
Dear Ms. Hoffman:
We have reviewed your Section 510(k) notification of intent to market the device referenced we have levice your booded by t(e); is substantially equivalent (for the indications for above and we nave actornined and as as as as a marketed predicate devices marketed in interstate use stated in the cherosule, to loging the enactment date of the Medical Device Amendments, Commence prior to may 20, 1778, ais = 12, ais = 12, accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, thereforc, market the device, subject to the r ood, Drug, and Cosmitator reviews of the Act. The general controls provisions of the Act include general controls provisions creation, 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 requirements, 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.
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Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this devices Under the Clinical Laboratory Improvement Anchanicalize of 1766 ( ons. 3 vou should contact ( 1977)
may require a CLIA complexity categorization. To determine if it docs, yo may require a CLIA complexity categorization (CDC) at (770)488-7655.
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) This letter will allow you to begin maikeding your antial equivalence of your device to a premarket notification. The FDA midling of substantial oquration or 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 OFF Part 801 If you desire specific acritic in your disguostic devices an the promotions and and additionally 809.10 for in viag ditignedly for questions on the promotion and Compliance at (301) 5944786. Adontact the Office of Compliance at (301) 594-4639.
advertising of your device, please contact the Office of Compliances to premarket Also, please note the regulation entitled, "Misbranding by reference to premarket Also, please note the regulation on the same on your responsibilities under the nouncedon' (21 CFN 807.97). Suision of Small Manufacturers Assistance at its toll free Act may be obtained no 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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510(k) Number (if known):
BACTEC® MGIT™ 960 System Device Name:
Indications For Usc:
The BACTEC® MGIT™ 960 System is an in vitro diagnostic instrument designed and The BACTEC "MGT" - 300 Uystell mycobacterial specimens (except blood
optimized for the rapid detection of mycobacterial and incouleted into RRI optimized for the rapid delection of informations processed and inoculated into BBL®
and urine). Samples are collected from patients, processed and inoculation in CRBL® MOIT and urine). Samples are collected iront patients, procobod and incolance in the mail.
MGIT™ 7mL tubes supplemented with BBL® MGIT™ and BBL® MGIT™ OADC.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| -- | -------------------------------------------------------- |
| (Division Sign-Off) | |
|---|---|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K974883 |
| Prescription Use(Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| ------------------------------------------ | ---- | ---------------------- |
(Optional Forroat 1-2-96)
§ 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.