(147 days)
No Reference Device(s) K/DEN number found in the text.
No
The device description explicitly states that the determination of susceptible or resistant is performed manually by the user. There is no mention of automated decision-making or algorithmic analysis of the growth data.
No.
The device is used for in vitro susceptibility testing of Mycobacterium tuberculosis to pyrazinamide, which is a diagnostic procedure, not a therapeutic intervention.
Yes
Explanation: The device is used for "susceptibility testing of Mycobacterium tuberculosis" to a drug (pyrazinamide). This process involves observing the growth of bacteria in the presence and absence of the drug to determine if the bacteria are susceptible or resistant. This information is crucial for guiding treatment decisions, which is a diagnostic function.
No
The device description clearly indicates it is a susceptibility testing kit that includes reagents (Myco Growth Supplement, VersaTREK® MYCO PZA reagent) and is used with specific hardware systems (ESP Culture System II and VersaTREK® Microbial Detection System). It is a physical kit used in a laboratory setting, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is a "rapid qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture to pyrazinamide (PZA)." This is a diagnostic test performed on a biological sample (culture of Mycobacterium tuberculosis) to determine its susceptibility to a drug.
- Device Description: The description details how the test is performed using specific reagents and a culture system to measure growth in the presence and absence of the drug. This process is characteristic of in vitro diagnostic testing.
- Sample Type: The test is performed on a "standard suspension of Mycobacterium tuberculosis growth is prepared from a liquid (seed inoculum)," which is a biological sample derived from a patient.
- Performance Studies: The document includes descriptions of analytical and clinical studies to evaluate the performance of the device, which is a requirement for IVDs.
- Predicate Device: The mention of a "Predicate Device" (BACTEC® 460TB PZA Kit) indicates that this device is being compared to a previously cleared IVD device.
All these factors strongly indicate that the VersaTREK® MYCO PZA KIT is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The VersaTREK® MYCO PZA KIT is used as a rapid qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture to pyrazinamide (PZA). The VersaTREK® MYCO PZA KIT is used with the ESP Culture System II (ESP) and the VersaTREK® Microbial Detection System (VTI).
Product codes
MJA
Device Description
The VersaTREK® MYCO PZA susceptibility testing kit is used with the VersaTREK MYCO culture bottle and performed on the ESP Culture System II and on the VersaTREK® Microbial Detection System. The MYCO bottles are supplemented with Myco Growth Supplement and VersaTREK® MYCO PZA reagent and prepared with the appropriate dilution of pyrazinamide as the mechanism for performing the susceptibility test.
The VersaTREK® MYCO PZA susceptibility test utilizes a 3 to 15 day testing protocol. A standard suspension of Mycobacterium tuberculosis growth is prepared from a liquid (seed inoculum). 0.5 mL is inoculated into a Growth Control bottle (drug-free), and a bottle containing PZA (both bottles are referred to as an AST set). The test determination is based upon growth of the M. tuberculosis isolate in the Growth Control Bottle compared to the growth in the drug-containing bottle.
At the completion of the PZA susceptibility testing protocol, the determination of susceptible or resistant is performed manually by the user, by comparing the time to detection of the Growth Control Bottle to the PZA test bottle.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Analytical studies:
Determination of critical drug concentration: The MIC results of the susceptible strains were ≤200 µg/mL. Thus, the critical concentration was set at 300 µg/mL. Verification of the critical cut off was done with the four resistant strains.
Lot Reproducibility: Lot reproducibility was performed using 4 well-characterized strains of Mycobacterium tuberculosis strains, which were tested in triplicate on three separate days. The strains tested were two ATCC® strains and two strains from CDC. Three different lots of reagents were represented in the testing. The overall reproducibility was 100% for seeded inoculum. Two susceptible strains of M. tuberculosis were tested at 25, 50, 100 and 200 µg/mL with two lots of Myco broth and GS. The resistant strain, also tested with 2 lots of Myco broth and GS, was tested at 300 µg/mL. There was no difference in results for the susceptible strains, and all test bottles of the resistant strain were resistant. Eight lots of manufactured PZA, seven myco broth and six Myco GS were evaluated for reproducibility with acceptable results for all lots.
CDC Challenge Panel Testing: The performance of the VersaTREK® MYCO PZA KIT was evaluated using 10 strains of Mycobacterium tuberculosis obtained from the Centers for Disease Control (CDC). Observed results were compared to BACTEC and expected results. The overall agreement was 100 %.
Comparison of the VersaTREK® Microbial Detection System to the ESP Culture System II: Recovery of different microorganisms and the time to detection was used to demonstrate no difference in the performance between ESP Culture System II and the VersaTREK Microbial Detection System with additional testing of M. tuberculosis and PZA. Results and time to detection by either system were not significantly different.
Clinical Studies:
Lot Reproducibility: Lot reproducibility was performed using two well-characterized strains of M. tuberculosis from CDC using two lots each of Myco broth and MYCO GS. Testing was performed in triplicate and on three separate days. The overall reproducibility was ≥ 95% for seeded inoculum.
Challenge Testing: CDC challenge set of 30 organisms was tested at three sites. Of the possible 90 test points, only 77 were valid. The lower number of tests (7.2% repeat rate) was due to no growth, contamination or instrument issues. Of the 77 organisms tested, 68 were susceptible and 9 were resistant. There was an overall agreement of 98.7% with expected results.
Clinical Isolate testing: A total of 96 tests were performed on samples from seed bottle inoculum. The VersaTREK® MYCO PZA KIT demonstrated a category agreement of 88%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Overall reproducibility of 100% and ≥95% (seeded inoculum). Overall agreement of 100% and 98.7% (with expected results). Category agreement of 88%.
Predicate Device(s)
BACTEC® 460TB PZA Kit (K895362)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.1640 Antimicrobial susceptibility test powder.
(a)
Identification. An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.(b)
Classification. Class II (performance standards).
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JAN 1 9 2006
Image /page/0/Picture/2 description: The image shows the logo for Trek Diagnostic Systems. The logo consists of the word "TREK" in a stylized font, with a black swoosh underneath the "T". To the right of "TREK" is the text "DIAGNOSTIC SYSTEMS", also in a stylized font. The text is in all caps.
510(k) SUMMARY
SUBMITTED BY: TREK Diagnostic Systems 210 Business Park Drive Sun Prairie, WI 52590 CONTACT NAME: Nadine M. Sullivan, Ph.D. Tel. (608) 837-3788 Ext. 152 Fax: (608) 837-3658 Email: nsullivan@trekds.com DATE PREPARED: August 23, 2005; revised January 17, 2006 DEVICE TRADE NAME: VersaTREK® MYCO PZA KIT DEVICE COMMON NAME: Antimicrobial susceptibility test powder DEVICE CLASSIFICATION: 21 CFR 866.1640 - Product code: MJA PREDICATE DEVICE: BACTEC® 460TB PZA Kit
INTENDED USE:
The VersaTREK® MYCO PZA KIT is used as a rapid qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture to pyrazinamide (PZA). The VersaTREK® MYCO PZA KIT is used with the ESP Culture System II (ESP) and the VersaTREK® Microbial Detection System (VTI).
DEVICE DESCRIPTION:
The VersaTREK® MYCO PZA susceptibility testing kit is used with the VersaTREK MYCO culture bottle and performed on the ESP Culture System II and on the VersaTREK® Microbial Detection System. The MYCO bottles are supplemented with Myco Growth Supplement and VersaTREK® MYCO PZA reagent and prepared with the
1
appropriate dilution of pyrazinamide as the mechanism for performing the susceptibility test.
The VersaTREK® MYCO PZA susceptibility test utilizes a 3 to 15 day testing protocol. A standard suspension of Mycobacterium tuberculosis growth is prepared from a liquid (seed inoculum). 0.5 mL is inoculated into a Growth Control bottle (drug-free), and a bottle containing PZA (both bottles are referred to as an AST set). The test determination is based upon growth of the M. tuberculosis isolate in the Growth Control Bottle compared to the growth in the drug-containing bottle.
At the completion of the PZA susceptibility testing protocol, the determination of susceptible or resistant is performed manually by the user, by comparing the time to detection of the Growth Control Bottle to the PZA test bottle.
| FEATURE | BACTEC 460TB
PZA Kit | ESP | VersaTREK |
|------------------------------------|--------------------------------------------------------------------------------|--------------------------------------------|--------------------------------------------|
| Intended use | Qualitative
susceptibility testing
of M. tuberculosis
to pyrazinamide | Same | Same |
| Test organism | Pure culture of M.
tuberculosis | Same | Same |
| Test Drug | PZA | Same | Same |
| Test determination | Compares growth of
a drug-free control
to that of PZA | Same | Same |
| Susceptibility
results | Susceptible or
resistant | Same | Same |
| Test protocol cycle | 4-21 days | 3-15 days | 3-15 days |
| Final PZA Drug
concentration/mL | 100µg | 300µg | 300µg |
| Growth medium | Supplemented
Middlebrook H9
with reduced pH | Same | Same |
| Medium additives | Albumin, catalase | Oleic acid, catalase,
dextrose, albumin | Oleic acid, catalase,
dextrose, albumin |
| Inoculum for testing | Subcultured solid or
liquid broth | Subcultured liquid
(seed) broth | Subcultured liquid
(seed) broth |
| User manipulation
for reading | Yes
Requires offline
incubation | No | No |
| Sensor | Radioactive labeled
carbon dioxide | Pressure sensor | Pressure sensor |
DEVICE COMPARISON
2
| ( $^{14}CO_2$ )-fatty acid | |||
|---|---|---|---|
| Monitoring of test | Once daily | Continuous | |
| monitoring | Continuous | ||
| monitoring | |||
| Growth monitored | |||
| by: | Radioactive labeled | ||
| carbon dioxide | |||
| ( $^{14}CO_2$ ) liberated | |||
| into the vial head | |||
| space | Changes in gas | ||
| pressure in the | |||
| bottle head space | Changes in gas | ||
| pressure in the | |||
| bottle head space | |||
| Interpretation of test | Manually calculated | Same | Same |
| Organism volume | 0.5 mL | 0.5 mL | 0.5 mL |
| Incubation | |||
| Temperature | 37°C | 35°C | 35°C |
SUMMARY OF PERFORMANCE DATA:
Analytical studies:
Determination of critical drug concentration:
The determination of critical PZA concentration was done by determining the minimal inhibitory concentration (MIC) for six susceptible wild strains of Mycobacterium tuberculosis and four resistant strains. The MIC results of the susceptible strains were ≤200 µg/mL. Thus, the critical concentration was set at 300 µg/mL. Verification of the critical cut off was done with the four resistant strains.
Lot Reproducibility:
Lot reproducibility was performed using 4 well-characterized strains of Mycobacterium tuberculosis strains, which were tested in triplicate on three separate days. The strains tested were two ATCC® strains and two strains from CDC. Three different lots of reagents were represented in the testing.. The overall reproducibility was 100% for seeded inoculum.
Two susceptible strains of M. tuberculosis were tested at 25, 50, 100 and 200 µg/mL with two lots of Myco broth and GS. The resistant strain, also tested with 2 lots of Myco broth and GS, was tested at 300 µg/mL. There was no difference in results for the susceptible strains, and. all test bottles of the resistant strain were resistant.
Eight lots of manufactured PZA, seven myco broth and six Myco GS were evaluated for reproducibility with acceptable results for all lots.
CDC Challenge Panel Testing
The performance of the VersaTREK® MYCO PZA KIT was evaluated using 10 strains of Mycobacterium tuberculosis obtained from the Centers for Disease Control (CDC). Observed results were compared to BACTEC and expected results. The overall agreement was 100 %.
3
Comparison of the VersaTREK® Microbial Detection System to the ESP Culture System II
System II
Recovery of different microorganisms and the time to detection was used to demorstrate no difference in the performance between ESP Culture System II and the VersaTREK Microbial Detection System with additional testing of M. tuberculosis and PZA. There Results and time to detection by either system were not significantly different.
Clinical Studies:
The VersaTREK® MYCO PZA KIT was evaluated at 5 geographical diverse clinical sites, composed of regional reference centers, university- and community-based laboratories.
Lot Reproduducibility:
Lot reproducibility was performed using two well-characterized strains of M. tuberculosis from CDC using two lots each of Myco broth and MYCO GS. Testing was performed in triplicate and on three separate days. The overall reproducibility was ≥ 95% for seeded inoculum.
Challenge Testing:
CDC challenge set of 30 organisms was tested at three sites. Of the possible 90 test points, only 77 were valid. The lower number of tests (7.2% repeat rate) was due to no growth, contamination or instrument issues. Of the 77 organisms tested, 68 were susceptible and 9 were resistant. There was an overall agreement of 98.7% with expected results
Clinical Isolate testing:
A total of 96 tests were performed on samples from seed bottle inoculum . The VersaTREK® MYCO PZA KIT demonstrated a category agreement of 88%.
Conclusions:
Data presented in this document demonstrates that the VersaTREK® MYCO PZA KIT is substantially equivalent to the BACTEC® 460 TB PZA Kit (K895362).
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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three abstract human figures. The figures are arranged in a way that suggests movement or progress. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
098 Gaither Road Ockville MD 2085
DEC 1 8 2002
Mr. James L. Brown Senior Vice President, Chief Operating Officer Diagnostics Hybrids, Inc. 350 West State Street Athens, OH 45701
- K022713 Re:
Kozz 11-Regulation Number: 21 CFR 866.3330 Regulation Name: Influenza Virus Scrological Reagents Regulatory Class: Class I Product Code: GNW Dated: October 31, 2002 Received: November 1. 2002
Dear Mr. Brown:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have and have 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 for associated in the May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adultcration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
5
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and three streamers flowing from its body. The eagle is positioned inside a circle of text that reads "U.S. Department of Health & Human Services - USA".
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN 1 9 2006
Ms. Nadine M. Sullivan Chief Science Officer TREK Diagnostic Systems, Inc. 210 Business Park Drive Sun Prairie, WI 53590
K052323 Re:
Trade/Device Name: Versa TREK® MYCO PZA KIT 300µ/ml Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Regulatory Class: Class II Product Code: MJA Dated: November 11, 2005 Received: December 2, 2005
Dear Ms. Sullivan:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rollewou your we determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for association to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou mayy atests provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 r reaso oe actived a determination that your device complies with other requirements of the Act or any Fedcral statutes and regulations administered by other Federal agencies. You must or any I edoral button and including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
6
Page 2 --
This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240)276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Sally, a Hogg
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
7
Indications for Use
K052323 510(k) Number (if known): Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The VersaTREK MYCO PZA KIT is a rapid qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture, to pyrazinamide (PZA).
The VersaTREK MYCO PZA KIT is used with the ESP Culture System II or with the rne VersaTREK Microbial Detection System. The VersaTREK MYCO PZA KIT final test concentration is 300 µg/ml for PZA.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
(21 CFR 807 Subpart C)
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
fell at
Division Sigh-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k)________________________________________________________________________________________________________________________________________________________________________