(615 days)
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.
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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the NATtrol™ BD MAX Vaginal Panel External Controls.
Disclaimer: The provided text is a 510(k) Summary for a medical device (Assayed Quality Control Material). This type of device does not involve "AI" or "human readers" in the context of diagnostic interpretation. Therefore, sections related to AI/human reader performance, multi-reader multi-case studies, and specific expert qualifications/adjudication methods are not applicable to this type of product and will be marked as such. The "ground truth" here refers to the expected qualitative result for the control material based on its composition.
1. Table of Acceptance Criteria and Reported Device Performance
| Control Type | Target | Acceptance Criteria (Expected Result) | Reported Device Performance (BD MAX Result - Observed/Total) | % Agreement with Expected Results (95% CI) |
|---|---|---|---|---|
| BV Positive Control | BV | Positive | Positive (84/86) | 97.7% (91.9%-99.4%) |
| C group | Negative | Negative (86/86) | 100% (95.7%-100%) | |
| C. krusei | Negative | Negative (86/86) | 100% (95.7%-100%) | |
| C. glabrata | Negative | Negative (86/86) | 100% (95.7%-100%) | |
| TV | Negative | Negative (86/86) | 100% (95.7%-100%) | |
| Candida/TV Positive Control | BV | Negative | Negative (102/104) | 98.1% (93.3%-99.5%) |
| C group | Positive | Positive (103/104) | 99.0% (94.8%-99.8%) | |
| C. krusei | Positive | Positive (103/104) | 99.0% (94.8%-99.8%) | |
| C. glabrata | Positive | Positive (103/104) | 99.0% (94.8%-99.8%) | |
| TV | Positive | Positive (103/104) | 99.0% (94.8%-99.8%) | |
| BV Negative Control | BV | Negative | Negative (191/191) | 100% (98.0%-100%) |
| C group | Negative | Negative (189/191) | 99.0% (96.3%-99.7%) | |
| C. krusei | Negative | Negative (191/191) | 100% (98.0%-100%) | |
| C. glabrata | Negative | Negative (191/191) | 100% (98.0%-100%) | |
| TV | Negative | Negative (191/191) | 100% (98.0%-100%) |
Study Details:
2. Sample size used for the test set and the data provenance
- BV Positive Control: 86 tests (total observations for each target).
- Candida/TV Positive Control: 104 tests (total observations for each target).
- BV Negative Control: 191 tests (total observations for each target).
- Data Provenance: Single site performance study, retrospective (data collected during multiple studies). The country of origin is not explicitly stated, but the sponsor address is Buffalo, NY, USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. For this type of quality control material, the "ground truth" is based on the known composition of the control and the expected qualitative result (positive/negative) for each target when tested on the BD MAX System. It does not involve expert interpretation or consensus on clinical samples.
4. Adjudication method for the test set
- Not applicable. See point 3.
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
- Not applicable. This device is a quality control material for an in vitro diagnostic (nucleic acid testing) system, not an AI software or a device interpreted by human readers for diagnostic purposes.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is framed for AI/algorithm performance. In the context of this device, the "standalone" performance is essentially what is reported: the control material's behavior when run on the BD MAX System as intended. The BD MAX System itself is an automated diagnostic platform, so the control material is tested by the algorithm/system without human interpretative input beyond setting up the test correctly. Therefore, the reported performance is the standalone performance of the control material with the BD MAX system.
7. The type of ground truth used
- Known Composition / Expected Qualitative Result: The positive and negative ground truths for each target for each control were established by the known composition of the control material (e.g., BV Positive Control contains Lactobacillus jensenii, Gardnerella vaginalis, Atopobium vaginae, and BVAB2 sequence, so it's expected to be positive for BV and negative for the other targets).
8. The sample size for the training set
- Not applicable. This device itself is a quality control material; it is not an algorithm that requires a training set in the conventional machine learning sense. The manufacturer would have developed and optimized the control formulation, but there isn't a "training set" like for a diagnostic algorithm.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
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February 2, 2022
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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
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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
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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) |
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510(k) SUMMARY
| Date of Summary: | November 12, 2021 |
|---|---|
| Product Name: | NATtrol™ BD MAX Vaginal Panel External Controls |
| Sponsor: | ZeptoMetrix, LLC878 Main StreetBuffalo, NY. 14202 |
| Correspondent: | MDC Associates, Inc.Michael Smith, Manager, Regulatory and Clinical Affairs180 Cabot StreetBeverly, MA 01915Phone: (978) 927 3808Fax: (866) 540 3448Email: 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 CorporationNATtrol™ BD MAX Vaginal Panel ExternalControls (New Device) | Microbiologics, Inc.BD MAX CT/GC/TV 20-Day QC PanelK181683(Predicate Device) |
|---|---|---|
| Similarities | ||
| Intended Use | NATtrol™ BV Negative Control(NATBVNEG-BD) is intended for use as anassayed quality control material tomonitor the performance of in vitrodiagnostic laboratory nucleic acid testingprocedures for the qualitative detection oftargets on the BD Vaginal Panel for BDMAX™ System. NATtrol BV NegativeControl is a qualitative control containingintact and inactivated Lactobacillus crispatus and intended to be used solelywith the BD Vaginal Panel for BD MAX™System. This product is not intended toreplace manufacturer controls provided inthe 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 isintended for use as an external assayed positivequality control material to monitor theperformance of in vitro laboratory nucleic acidtesting procedures for the qualitative detectionof Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis with theBD MAX CT/GC/TV Assay on the BD MAXSystem. The controls comprise cultured andinactivated C. trachomatis, N. gonorrhoeae andT. vaginalis . The BD MAX CT/GC/TV 20-Day QCPanel is not intended to replace manufacturercontrols provided with the device. |
| Description | ZeptoMetrix CorporationNATtrolTM BD MAXTM Vaginal Panel ExternalControls (New Device) | Microbiologics, Inc.BD MAX CT/GC/TV 20-Day QC PanelK181683(Predicate Device) |
| quality control material to monitor theperformance of in vitro diagnosticlaboratory nucleic acid testing proceduresfor the qualitative detection of targets onthe BD Vaginal Panel for BD MAXTM System.NATtrolTM BV Positive Control is aqualitative control containing intact andinactivated Lactobacillus jensenii,Gardnerella vaginalis, Atopobium vaginae,and Saccharomyces cerevisiae containingBVAB2 (Bacterial Vaginosis-AssociatedBacterium 2) sequence and intended to beused solely with the BD Vaginal Panel forBD MAXTM System. This product is notintended to replace manufacturer controlsprovided in the package insert.NATtrolTM Candida/TV Positive Control(NATCTVPOS-BD) is intended for use as anassayed quality control material tomonitor the performance of in vitrodiagnostic laboratory nucleic acid testingprocedures for the qualitative detection oftargets on the BD Vaginal Panel for BDMAXTM System. NATtrolTM Candida/TVPositive Control is a qualitative controlcontaining intact and inactivated Candidaalbicans, Candida krusei, Candida glabrata,and Trichomonas vaginalis and intended tobe used solely with the BD Vaginal Panelfor the BD MAXTM System. This product isnot intended to replace manufacturercontrols 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 TargetsMonitored | 8 | 3 |
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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.
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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 | ||
|---|---|---|
| Target | BD MAX Result(Observed/Total) | % Agreement with expectedResults (95% CI) |
| BV | Positive (84/86) | 97.7%(91.9%-99.4%) |
| C group | Negative (86/86) | 100%(95.7%-100%) |
| C. krusei | Negative (86/86) | 100%(95.7%-100%) |
| C. glabrata | Negative (86/86) | 100%(95.7%-100%) |
| TV | Negative (86/86) | 100%(95.7%-100%) |
| Candida/TV Positive Control | ||
|---|---|---|
| Target | BD MAX Result(Observed/Total) | % Agreement with expectedResults (95% CI) |
| BV | Negative (102/104) | 98.1%(93.3%-99.5%) |
| C group | Positive (103/104) | 99.0%(94.8%-99.8%) |
| C. krusei | Positive (103/104) | 99.0%(94.8%-99.8%) |
| C. glabrata | Positive (103/104) | 99.0%(94.8%-99.8%) |
| TV | Positive (103/104) | 99.0%(94.8%-99.8%) |
| BV Negative Control | ||
|---|---|---|
| Target | BD MAX Result(Observed/Total) | % Agreement with expectedResults (95% CI) |
| BV | Negative (191/191) | 100%(98.0%-100%) |
| C group | Negative (189/191) | 99.0%(96.3%-99.7%) |
| C. krusei | Negative (191/191) | 100%(98.0%-100%) |
| C. glabrata | Negative (191/191) | 100%(98.0%-100%) |
| TV | Negative (191/191) | 100%(98.0%-100%) |
Conclusion
The submitted information in this premarket notification is complete and supports asubstantial equivalence decision.
§ 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.”