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 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.

AI/ML Overview

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

Acceptance Criteria and Device Performance

Acceptance Criteria / Performance Aspect	Reported Device Performance
Critical PZA Concentration	Set at 300 µg/mL. MIC results for susceptible strains were ≤200 µg/mL. Verification with resistant strains confirmed this cutoff.
Lot Reproducibility (Analytical)	100% for seeded inoculum across 4 well-characterized strains (2 ATCC, 2 CDC), tested in triplicate on 3 separate days with 3 different reagent lots. No difference in results for susceptible strains tested at various concentrations, and all resistant strains remained resistant. 8 lots of PZA, 7 Myco broth, and 6 Myco GS showed acceptable reproducibility.
CDC Challenge Panel Testing	100% overall agreement with BACTEC and expected results for 10 CDC Mycobacterium tuberculosis strains.
Equivalence between VersaTREK and ESP Systems	No significant difference in recovery of microorganisms, time to detection, or M. tuberculosis and PZA test results between ESP Culture System II and the VersaTREK Microbial Detection System.
Lot Reproducibility (Clinical)	≥ 95% for seeded inoculum across 2 well-characterized CDC M. tuberculosis strains, using 2 lots each of Myco broth and MYCO GS, tested in triplicate on 3 separate days.
Challenge Testing (Clinical)	For 77 valid tests from a 30-organism CDC challenge set (tested at 3 sites), there was an overall agreement of 98.7% with expected results.
Clinical Isolate Testing	88% category agreement for 96 tests performed on samples from seed bottle inoculum.

Study Details

A table of acceptance criteria and the reported device performance: (Provided above)
Sample size used for the test set and the data provenance:
- Analytical Studies:
  - Critical Drug Concentration: 6 susceptible wild strains and 4 resistant strains of M. tuberculosis.
  - Lot Reproducibility: 4 well-characterized M. tuberculosis strains (2 ATCC, 2 CDC).
  - CDC Challenge Panel Testing: 10 strains of Mycobacterium tuberculosis obtained from the Centers for Disease Control (CDC).
- Clinical Studies:
  - Lot Reproducibility: 2 well-characterized M. tuberculosis strains from CDC.
  - Challenge Testing: 30 organisms from a CDC challenge set, resulting in 77 valid test points.
  - Clinical Isolate Testing: A total of 96 tests from seed bottle inoculum.
- Data Provenance: The strains used were from known sources like ATCC and CDC, indicating well-characterized, reference strains. Clinical isolates were collected from 5 geographically diverse clinical sites, including regional reference centers, university- and community-based laboratories, suggesting real-world clinical samples. The study appears to be prospective in nature for the clinical isolate testing as it refers to performing tests on samples.
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 or qualifications of experts used to establish the ground truth. It refers to "expected results" and comparisons to the predicate device (BACTEC 460TB PZA Kit) and CDC-provided challenge sets, implying that the ground truth for these reference strains and challenge sets was pre-established and widely accepted in the field.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: The document does not specify an adjudication method. For the "Challenge Testing" in clinical studies, the "expected results" were used as the ground truth.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is an in-vitro diagnostic (IVD) kit for antimicrobial susceptibility testing, not an AI-assisted diagnostic tool that involves human readers interpreting images or data. The "user manipulation for reading" is mentioned as "Yes" for the predicate and "No" for the new device in the comparison table, but this refers to the automation of the reading process, not human interpretation improvement.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device itself performs the susceptibility testing. The interpretation of the test "is performed manually by the user, by comparing the time to detection of the Growth Control Bottle to the PZA test bottle." This indicates a manual interpretation step. However, the device determines the growth automatically (via pressure sensor). Therefore, while the final call is human-derived, the core measurement is automated, but it's not a standalone "algorithm only" in the sense of a fully automated diagnostic decision.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For analytical studies and challenge sets, the ground truth was based on known characteristics of reference strains (ATCC, CDC) and comparisons to the established predicate device (BACTEC 460TB PZA Kit), which implicitly relies on previous expert consensus or established laboratory methods.
- For clinical isolate testing, the 'expected results' would likely be derived from a reference method or expert consensus interpretation of growth patterns.
The sample size for the training set: Not applicable. This document describes performance studies for an IVD kit, not a machine learning model that requires a "training set."
How the ground truth for the training set was established: Not applicable, as there is no "training set" in the context of device performance studies described here.

Summary

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K052323

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:

DEVICE DESCRIPTION:

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appropriate dilution of pyrazinamide as the mechanism for performing the susceptibility test.

FEATURE	BACTEC 460TBPZA Kit	ESP	VersaTREK
Intended use	Qualitativesusceptibility testingof M. tuberculosisto pyrazinamide	Same	Same
Test organism	Pure culture of M.tuberculosis	Same	Same
Test Drug	PZA	Same	Same
Test determination	Compares growth ofa drug-free controlto that of PZA	Same	Same
Susceptibilityresults	Susceptible orresistant	Same	Same
Test protocol cycle	4-21 days	3-15 days	3-15 days
Final PZA Drugconcentration/mL	100µg	300µg	300µg
Growth medium	SupplementedMiddlebrook H9with reduced pH	Same	Same
Medium additives	Albumin, catalase	Oleic acid, catalase,dextrose, albumin	Oleic acid, catalase,dextrose, albumin
Inoculum for testing	Subcultured solid orliquid broth	Subcultured liquid(seed) broth	Subcultured liquid(seed) broth
User manipulationfor reading	YesRequires offlineincubation	No	No
Sensor	Radioactive labeledcarbon dioxide	Pressure sensor	Pressure sensor

DEVICE COMPARISON

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	( $^{14}CO_2$ )-fatty acid
Monitoring of test	Once daily	Continuousmonitoring	Continuousmonitoring
Growth monitoredby:	Radioactive labeledcarbon dioxide( $^{14}CO_2$ ) liberatedinto the vial headspace	Changes in gaspressure in thebottle head space	Changes in gaspressure in thebottle head space
Interpretation of test	Manually calculated	Same	Same
Organism volume	0.5 mL	0.5 mL	0.5 mL
IncubationTemperature	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 %.

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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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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).

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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.

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).

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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

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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)________________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 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).