K Number
K201403
Device Name
NATtrol BD MAX Vaginal Panel External Controls
Manufacturer
Date Cleared
2022-02-02

(615 days)

Product Code
Regulation Number
866.3920
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
NATtrol™ BV Negative Control (NATBVNEG-BD) is intended for use as an assayed quality control material to monitor the performance of in vitro diagnostic laboratory nucleic acid testing procedures for the qualitative detection of targets on the BD Vaginal Panel for BD MAX™ System. NATtrol BV Negative Control is a qualitative control containing intact and inactivated Lactobacillus crispatus and intended to be used solely with the BD Vaginal Panel for BD MAX™ System. This product is not intended to replace manufacturer controls provided in the package insert. NATtrol™ BV Positive Control (NATBVPOS-BD) is intended for use as an assayed quality control material to monitor the performance of in vitro diagnostic laboratory nucleic acid testing procedures for the qualitative detection of targets on the BD Vaginal Panel for BD MAX™ System. NATtrol™ BV Positive Control is a qualitative control containing intact and inactivated Lactobacillus jensenii, Gardnerella vaginalis, Atopobium vaginae, and Saccharomyces cerevisiae containing BVAB2 (Bacterial Vaginosis-Associated Bacterium 2) sequence and intended to be used solely with the BD Vaginal Panel for BD MAX™ System. This product is not intended to replace manufacturer controls provided in the package insert. NATtrol™ Candida/TV Positive Control (NATCTVPOS-BD) is intended for use as an assayed quality control material to monitor the performance of in vitro diagnostic laboratory nucleic acid testing procedures for the qualitative detection of targets on the BD Vaginal Panel for BD MAX™ System. NATtrol CandidaTV Positive Control is a qualitative control containing intact and inactivated Candida krusei, Candida glabrata, and Trichomonas vaginalis and intended to be used solely with the BD Vaginal Panel for the BD MAX™ System. This product is not intended to replace manufacturer controls provided in the package insert.
Device Description
NATtrol™ BD MAX Vaginal Panel External Controls are formulated with purified, intact microorganisms that have been chemically modified to render them non-infectious and refrigerator stable. The controls are formulated in a proprietary matrix that contains Fetal Bovine Serum, Human Serum Albumin, and sodium azide. NATtrol™ BV Positive Control contains intact and inactivated Lactobacillus jensenii, Gardnerella vaginalis, Atopobium vaginae, and Saccharomyces cerevisiae containing BVAB2 (Bacterial Vaginosis-Associated Bacterium 2) sequence. NATtrol™ Candida/TV Positive Control contains intact and inactivated Candida albicans, Candida krusei, Candida glabrata, and Trichomonas vaginalis. NATtrol™ BV Negative Control contains intact and inactivated Lactobacillus crispatus.
More Information

Not Found

No
The document describes quality control materials for a nucleic acid testing system. There is no mention of AI or ML in the intended use, device description, or performance studies. The device is a set of physical controls, not a software or analytical tool that would typically incorporate AI/ML.

No.
The device is described as an "assayed quality control material" intended to "monitor the performance of in vitro diagnostic laboratory nucleic acid testing procedures." It does not directly treat or diagnose a condition.

No.

Explanation: This device is described as an "assayed quality control material" intended to "monitor the performance of in vitro diagnostic laboratory nucleic acid testing procedures." It is used to ensure the accuracy of diagnostic tests rather than being a diagnostic device itself.

No

The device description clearly states that the controls are formulated with purified, intact microorganisms and a proprietary matrix containing biological components. This indicates a physical, biological product, not software.

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The "Intended Use / Indications for Use" section explicitly states that the controls are "intended for use as an assayed quality control material to monitor the performance of in vitro diagnostic laboratory nucleic acid testing procedures". This directly aligns with the definition of an IVD, which are used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or treatment.
  • Care Setting: The "Intended User / Care Setting" is listed as "in vitro diagnostic laboratory", further confirming its use in a clinical laboratory setting for diagnostic purposes.
  • Purpose: The controls are designed to monitor the performance of a specific IVD test (the BD Vaginal Panel for BD MAX™ System). This function is integral to ensuring the accuracy and reliability of the diagnostic test results.

While the controls themselves are not directly used to diagnose a patient, they are essential components in the quality control process of an IVD test, making them IVD devices themselves.

N/A

Intended Use / Indications for Use

NATtrol™ BV Negative Control (NATBVNEG-BD) is intended for use as an assayed quality control material to monitor the performance of in vitro diagnostic laboratory nucleic acid testing procedures for the qualitative detection of targets on the BD Vaginal Panel for BD MAX™ System. NATtrol BV Negative Control is a qualitative control containing intact and inactivated Lactobacillus crispatus and intended to be used solely with the BD Vaginal Panel for BD MAX™ System. This product is not intended to replace manufacturer controls provided in the package insert.

NATtrol™ BV Positive Control (NATBVPOS-BD) is intended for use as an assayed quality control material to monitor the performance of in vitro diagnostic laboratory nucleic acid testing procedures for the qualitative detection of targets on the BD Vaginal Panel for BD MAX™ System. NATtrol™ BV Positive Control is a qualitative control containing intact and inactivated Lactobacillus jensenii, Gardnerella vaginalis, Atopobium vaginae, and Saccharomyces cerevisiae containing BVAB2 (Bacterial Vaginosis-Associated Bacterium 2) sequence and intended to be used solely with the BD Vaginal Panel for BD MAX™ System. This product is not intended to replace manufacturer controls provided in the package insert.

NATtrol™ Candida/TV Positive Control (NATCTVPOS-BD) is intended for use as an assayed quality control material to monitor the performance of in vitro diagnostic laboratory nucleic acid testing procedures for the qualitative detection of targets on the BD Vaginal Panel for BD MAX™ System. NATtrol CandidaTV Positive Control is a qualitative control containing intact and inactivated Candida krusei, Candida glabrata, and Trichomonas vaginalis and intended to be used solely with the BD Vaginal Panel for the BD MAX™ System. This product is not intended to replace manufacturer controls provided in the package insert.

Product codes

PMN

Device Description

NATtrol™ BD MAX Vaginal Panel External Controls are formulated with purified, intact microorganisms that have been chemically modified to render them non-infectious and refrigerator stable. The controls are formulated in a proprietary matrix that contains Fetal Bovine Serum, Human Serum Albumin, and sodium azide.

NATtrol™ BV Positive Control contains intact and inactivated Lactobacillus jensenii, Gardnerella vaginalis, Atopobium vaginae, and Saccharomyces cerevisiae containing BVAB2 (Bacterial Vaginosis-Associated Bacterium 2) sequence.

NATtrol™ Candida/TV Positive Control contains intact and inactivated Candida albicans, Candida krusei, Candida glabrata, and Trichomonas vaginalis.

NATtrol™ BV Negative Control contains intact and inactivated Lactobacillus crispatus.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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

Not Found

Summary of Performance Studies

A single site performance study was conducted to evaluate precision and performance of the NATtrol™ BD MAX Vaginal Panel External Controls. The Performance of the controls was evaluated by observing the data collected during multiple studies performed by six (6) operators using two (2) lots of BV Positive, two (2) lots of BV Negative and one (1) lot of Candida/TV Positive controls.

BV Positive Control:
Target: BV, BD MAX Result: Positive (84/86), Agreement with expected Results: 97.7% (91.9%-99.4%)
Target: C group, BD MAX Result: Negative (86/86), Agreement with expected Results: 100% (95.7%-100%)
Target: C. krusei, BD MAX Result: Negative (86/86), Agreement with expected Results: 100% (95.7%-100%)
Target: C. glabrata, BD MAX Result: Negative (86/86), Agreement with expected Results: 100% (95.7%-100%)
Target: TV, BD MAX Result: Negative (86/86), Agreement with expected Results: 100% (95.7%-100%)

Candida/TV Positive Control:
Target: BV, BD MAX Result: Negative (102/104), Agreement with expected Results: 98.1% (93.3%-99.5%)
Target: C group, BD MAX Result: Positive (103/104), Agreement with expected Results: 99.0% (94.8%-99.8%)
Target: C. krusei, BD MAX Result: Positive (103/104), Agreement with expected Results: 99.0% (94.8%-99.8%)
Target: C. glabrata, BD MAX Result: Positive (103/104), Agreement with expected Results: 99.0% (94.8%-99.8%)
Target: TV, BD MAX Result: Positive (103/104), Agreement with expected Results: 99.0% (94.8%-99.8%)

BV Negative Control:
Target: BV, BD MAX Result: Negative (191/191), Agreement with expected Results: 100% (98.0%-100%)
Target: C group, BD MAX Result: Negative (189/191), Agreement with expected Results: 99.0% (96.3%-99.7%)
Target: C. krusei, BD MAX Result: Negative (191/191), Agreement with expected Results: 100% (98.0%-100%)
Target: C. glabrata, BD MAX Result: Negative (191/191), Agreement with expected Results: 100% (98.0%-100%)
Target: TV, BD MAX Result: Negative (191/191), Agreement with expected Results: 100% (98.0%-100%)

Key Metrics

Not Found

Predicate Device(s)

Microbiologics, Inc. BD MAX CT/GC/TV 20-Day QC Panel (K181683)

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 866.3920 Assayed quality control material for clinical microbiology assays.

(a)
Identification. An assayed quality control material for clinical microbiology assays is a device indicated for use in a test system to estimate test precision or to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. This type of device consists of single or multiple microbiological analytes intended for use with either qualitative or quantitative assays.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Premarket notification submissions must include detailed device description documentation and information concerning the composition of the quality control material, including, as appropriate:
(i) Analyte concentration;
(ii) Expected values;
(iii) Analyte source;
(iv) Base matrix;
(v) Added components;
(vi) Safety and handling information; and
(vii) Detailed instructions for use.
(2) Premarket notification submissions must include detailed documentation, including line data as well as detailed study protocols and a statistical analysis plan used to establish performance, including:
(i) Description of the process for value assignment and validation.
(ii) Description of the protocol(s) used to establish stability.
(iii) Line data establishing precision/reproducibility.
(iv) Where applicable, assessment of matrix effects and any significant differences between the quality control material and typical patient samples in terms of conditions known to cause analytical error or affect assay performance.
(v) Where applicable, identify or define traceability or relationship to a domestic or international standard reference material and/or method.
(vi) Where applicable, detailed documentation related to studies for surrogate controls.
(3) Premarket notification submissions must include an adequate mitigation (e.g., real-time stability program) to the risk of false results due to potential modifications to the assays specified in the device's 21 CFR 809.10 compliant labeling.
(4) Your 21 CFR 809.10 compliant labeling must include the following:
(i) The intended use of your 21 CFR 809.10(a)(2) and (b)(2) compliant labeling must include the following:
(A) Assayed control material analyte(s);
(B) Whether the material is intended for quantitative or qualitative assays;
(C) Stating if the material is a surrogate control; and
(D) The system(s), instrument(s), or test(s) for which the quality control material is intended.
(ii) The intended use in your 21 CFR 809.10(a)(2) and (b)(2) compliant labeling must include the following statement: “This product is not intended to replace manufacturer controls provided with the device.”
(iii) A limiting statement that reads “Quality control materials should be used in accordance with local, state, federal regulations, and accreditation requirements.”

0

February 2, 2022

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in a larger, bold blue font, and the word "ADMINISTRATION" in a smaller, lighter blue font below.

Zeptometrix % Michael Smith Manager, Regulatory and Clinical Affairs MDC Associates Inc. 180 Cabot Street Beverly, Massachusetts 01915

Re: K201403

Trade/Device Name: NATtrol Vaginal Panel External Run Controls Regulation Number: 21 CFR 866.3920 Regulation Name: Assayed Quality Control Material For Clinical Microbiology Assays Regulatory Class: Class II Product Code: PMN Dated: May 26, 2020 Received: May 28, 2020

Dear Michael Smith:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above 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 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) 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you. however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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

1

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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For

Maria Garcia, Ph.D. Branch Chief Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K201403

Device Name

NATtrol™ BD MAX Vaginal Panel External Controls

Indications for Use (Describe)

NATtrol™ BV Negative Control (NATBVNEG-BD) is intended for use as an assayed quality control material to monitor the performance of in vitro diagnostic laboratory nucleic acid testing procedures for the qualitative detection of targets on the BD Vaginal Panel for BD MAX™ System. NATtrol BV Negative Control is a qualitative control containing intact and inactivated Lactobacillus crispatus and intended to be used solely with the BD Vaginal Panel for BD MAX™ System. This product is not intended to replace manufacturer controls provided in the package insert.

NATtroI™ BV Positive Control (NATBVPOS-BD) is intended for use as an assayed quality control material to monitor the performance of in vitro diagnostic laboratory nucleic acid testing procedures for the qualitative detection of targets on the BD Vaginal Panel for BD MAX™ System. NATtrol™ BV Positive Control is a qualitative control containing intact and inactivated Lactobacillus jensenii, Gardnerella vaginalis, Atopobium vaginae, and Saccharomyces cerevisiae containing BVAB2 (Bacterial Vaginosis-Associated Bacterium 2) sequence and intended to be used solely with the BD Vaginal Panel for BD MAX™ System. This product is not intended to replace manufacturer controls provided in the package insert.

NATtrol™ Candida/TV Positive Control (NATCTVPOS-BD) is intended for use as an assayed quality control material to monitor the performance of in vitro diagnostic laboratory nucleic acid testing procedures for the qualitative detection of targets on the BD Vaginal Panel for BD MAX™ System. NATtrol CandidaTV Positive Control is a qualitative control containing intact and inactivated Candida krusei, Candida glabrata, and Trichomonas vaginalis and intended to be used solely with the BD Vaginal Panel for the BD MAX™ System. This product is not intended to replace manufacturer controls provided in the package insert.

Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

3

510(k) SUMMARY

Date of Summary:November 12, 2021
Product Name:NATtrol™ BD MAX Vaginal Panel External Controls
Sponsor:ZeptoMetrix, LLC
878 Main Street
Buffalo, NY. 14202
Correspondent:MDC Associates, Inc.
Michael Smith, Manager, Regulatory and Clinical Affairs
180 Cabot Street
Beverly, MA 01915
Phone: (978) 927 3808
Fax: (866) 540 3448
Email: regulatory@mdcassoc.com
Common Name:Assayed quality control material for clinical microbiology assays.
Regulation Number:866.3920
Classification:Class II
Predicate Device:Microbiologics, Inc. BD MAX CT/GC/TV 20-Day QC Panel (K181683)

Substantial Equivalency

| Description | ZeptoMetrix Corporation
NATtrol™ BD MAX Vaginal Panel External
Controls (New Device) | Microbiologics, Inc.
BD MAX CT/GC/TV 20-Day QC Panel
K181683
(Predicate Device) |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | NATtrol™ BV Negative Control
(NATBVNEG-BD) is intended for use as an
assayed quality control material to
monitor the performance of in vitro
diagnostic laboratory nucleic acid testing
procedures for the qualitative detection of
targets on the BD Vaginal Panel for BD
MAX™ System. NATtrol BV Negative
Control is a qualitative control containing
intact and inactivated Lactobacillus crispatus and intended to be used solely
with the BD Vaginal Panel for BD MAX™
System. This product is not intended to
replace manufacturer controls provided in
the package insert.

NATtrol™ BV Positive Control (NATBVPOS-
BD) is intended for use as an assayed | The BD MAX CT/GC/TV 20-Day QC Panel is
intended for use as an external assayed positive
quality control material to monitor the
performance of in vitro laboratory nucleic acid
testing procedures for the qualitative detection
of Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis with the
BD MAX CT/GC/TV Assay on the BD MAX
System. The controls comprise cultured and
inactivated C. trachomatis, N. gonorrhoeae and
T. vaginalis . The BD MAX CT/GC/TV 20-Day QC
Panel is not intended to replace manufacturer
controls provided with the device. |
| Description | ZeptoMetrix Corporation
NATtrolTM BD MAXTM Vaginal Panel External
Controls (New Device) | Microbiologics, Inc.
BD MAX CT/GC/TV 20-Day QC Panel
K181683
(Predicate Device) |
| | quality control material to monitor the
performance of in vitro diagnostic
laboratory nucleic acid testing procedures
for the qualitative detection of targets on
the BD Vaginal Panel for BD MAXTM System.
NATtrolTM BV Positive Control is a
qualitative control containing intact and
inactivated Lactobacillus jensenii,
Gardnerella vaginalis, Atopobium vaginae,
and Saccharomyces cerevisiae containing
BVAB2 (Bacterial Vaginosis-Associated
Bacterium 2) sequence and intended to be
used solely with the BD Vaginal Panel for
BD MAXTM System. This product is not
intended to replace manufacturer controls
provided in the package insert.

NATtrolTM Candida/TV Positive Control
(NATCTVPOS-BD) is intended for use as an
assayed quality control material to
monitor the performance of in vitro
diagnostic laboratory nucleic acid testing
procedures for the qualitative detection of
targets on the BD Vaginal Panel for BD
MAXTM System. NATtrolTM Candida/TV
Positive Control is a qualitative control
containing intact and inactivated Candida
albicans, Candida krusei, Candida glabrata,
and Trichomonas vaginalis and intended to
be used solely with the BD Vaginal Panel
for the BD MAXTM System. This product is
not intended to replace manufacturer
controls provided in the package insert. | |
| Composition | Inactivated microorganisms | Same |
| Test system | BD MAX System | Same |
| Assay Steps Monitored | Extraction, amplification and detection | Same |
| Analytes | Inactivated microorganisms | Same |
| | Differences | |
| Physical Format | Ready-to-use liquid | Lyophilized pellet |
| Number of Targets
Monitored | 8 | 3 |

4

5

Intended Use

NATtrol™ BV Negative Control (NATBVNEG-BD) is intended for use as an assayed quality control material to monitor the performance of in vitro diagnostic laboratory nucleic acid testing procedures for the qualitative detection of targets on the BD Vaginal Panel for BD MAX™ System. NATtrol BV Negative Control is a qualitative control containing intact and inactivated Lactobacillus crispatus and intended to be used solely with the BD Vaginal Panel for BD MAX™ System. This product is not intended to replace manufacturer controls provided in the package insert.

NATtrol™ BV Positive Control (NATBVPOS-BD) is intended for use as an assayed quality control material to monitor the performance of in vitro diagnostic laboratory nucleic acid testing procedures for the qualitative detection of targets on the BD Vaginal Panel for BD MAX™ System. NATtrol™ BV Positive Control is a qualitative control containing intact and inactivated Lactobacillus jensenii, Gardnerella vaginalis, Atopobium vaqinae, and Saccharomyces cerevisiae containing BVAB2 (Bacterial Vaginosis-Associated Bacterium 2) sequence and intended to be used solely with the BD Vaginal Panel for BD MAX™ System. This product is not intended to replace manufacturer controls provided in the package insert.

NATtrol™ Candida/TV Positive Control (NATCTVPOS-BD) is intended for use as an assayed quality control material to monitor the performance of in vitro diagnostic laboratory nucleic acid testing procedures for the qualitative detection of targets on the BD Vaginal Panel for BD MAX™ System. NATtrol Candida/TV Positive Control is a qualitative control containing intact and inactivated Candida albicans, Candida krusei, Candida qlabrata, and Trichomonas vaginalis and intended to be used solely with the BD Vaginal Panel for the BD MAX™ System. This product is not intended to replace manufacturer controls provided in the package insert.

Test Principle

Not applicable; this is control material to monitor performance of a test.

Device Description

NATtrol™ BD MAX Vaginal Panel External Controls are formulated with purified, intact microorganisms that have been chemically modified to render them non-infectious and refrigerator stable. The controls are formulated in a proprietary matrix that contains Fetal Bovine Serum, Human Serum Albumin, and sodium azide.

NATtrol™ BV Positive Control contains intact and inactivated Lactobacillus jensenii, Gardnerella vaginalis, Atopobium vaginae, and Saccharomyces cerevisiae containing BVAB2 (Bacterial Vaginosis-Associated Bacterium 2) sequence.

NATtrol™ Candida/TV Positive Control contains intact and inactivated Candida albicans, Candida krusei, Candida glabrata, and Trichomonas vaginalis.

NATtrol™ BV Negative Control contains intact and inactivated Lactobacillus crispatus.

6

Performance Data

A single site performance study was conducted to evaluate precision and performance of the NATtrol™ BD MAX Vaginal Panel External Controls. The Performance of the controls was evaluated by observing the data collected during multiple studies performed by six (6) operators using two (2) lots of BV Positive, two (2) lots of BV Negative and one (1) lot of Candida/TV Positive controls.

BV Positive Control
TargetBD MAX Result
(Observed/Total)% Agreement with expected
Results (95% CI)
BVPositive (84/86)97.7%
(91.9%-99.4%)
C groupNegative (86/86)100%
(95.7%-100%)
C. kruseiNegative (86/86)100%
(95.7%-100%)
C. glabrataNegative (86/86)100%
(95.7%-100%)
TVNegative (86/86)100%
(95.7%-100%)
Candida/TV Positive Control
TargetBD MAX Result
(Observed/Total)% Agreement with expected
Results (95% CI)
BVNegative (102/104)98.1%
(93.3%-99.5%)
C groupPositive (103/104)99.0%
(94.8%-99.8%)
C. kruseiPositive (103/104)99.0%
(94.8%-99.8%)
C. glabrataPositive (103/104)99.0%
(94.8%-99.8%)
TVPositive (103/104)99.0%
(94.8%-99.8%)
BV Negative Control
TargetBD MAX Result
(Observed/Total)% Agreement with expected
Results (95% CI)
BVNegative (191/191)100%
(98.0%-100%)
C groupNegative (189/191)99.0%
(96.3%-99.7%)
C. kruseiNegative (191/191)100%
(98.0%-100%)
C. glabrataNegative (191/191)100%
(98.0%-100%)
TVNegative (191/191)100%
(98.0%-100%)

Conclusion

The submitted information in this premarket notification is complete and supports asubstantial equivalence decision.