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 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 MAX™ System. This product is not intended to replace manufacturer controls provided in the package insert.
Device Story
NATtrol™ BD MAX Vaginal Panel External Controls consist of purified, intact, chemically inactivated microorganisms; formulated in a matrix containing Fetal Bovine Serum, Human Serum Albumin, and sodium azide. Used in clinical laboratories to monitor the performance of the BD MAX™ System (extraction, amplification, and detection steps) for vaginal panel assays. Controls are ready-to-use liquids; processed by laboratory technicians alongside patient samples. Output is a qualitative result (positive/negative) for specific vaginal pathogens; used by clinicians to verify assay validity and ensure reliable patient testing. Benefits include standardized quality assurance for molecular diagnostic workflows.
Clinical Evidence
Single-site performance study conducted with 6 operators using multiple lots of controls. Evaluated precision and performance against expected results on the BD MAX System. Results showed high agreement: BV Positive Control (97.7-100% agreement), Candida/TV Positive Control (98.1-99.0% agreement), and BV Negative Control (99.0-100% agreement). No clinical patient data; bench testing only.
Technological Characteristics
Formulated with purified, intact, chemically inactivated microorganisms. Matrix includes Fetal Bovine Serum, Human Serum Albumin, and sodium azide. Ready-to-use liquid format. Refrigerator stable. Designed for use with the BD MAX System (automated nucleic acid extraction, amplification, and detection).
Indications for Use
Indicated for use as external assayed quality control material for the BD Vaginal Panel on the BD MAX System to monitor qualitative nucleic acid amplification, detection, and identification steps. Used by laboratory personnel in clinical settings.
Regulatory Classification
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.
Special Controls
An assayed quality control material for clinical microbiology assays must comply with the following special controls: (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; Expected values: (ii) Analyte source: (iii) (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., realtime 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 in your 21 CFR 809.10(a)(2) and 21 CFR 809.10(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; (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 21 CFR 809.10(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."
*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.”
Predicate Devices
Microbiologics, Inc. BD MAX CT/GC/TV 20-Day QC Panel (K181683)
Submission Summary (Full Text)
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[LOGO]
FDA
U.S. FOOD & DRUG
ADMINISTRATION
### 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
ASSAY ONLY
### I Background Information:
#### A 510(k) Number
K201403
#### B Applicant
Zeptometrix
#### C Proprietary and Established Names
NATtrol Vaginal Panel External Run Controls
#### D Regulatory Information
| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| PMN | Class II | 21 CFR 866.3920 - Assayed Quality Control Material For Clinical Microbiology Assays | MI - Microbiology |
### II Submission/Device Overview:
#### A Purpose for Submission:
To obtain a substantial equivalence determination for the NATtrol BD MAX Vaginal Panel External Controls
#### B Measurand:
DNA sequences from the following eight (8) microorganisms:
- Lactobacillus jensenii
- Gardnerella vaginalis
- Atopobium vaginae
- Saccharomyces cerevisiae containing BVAB2 (Bacterial Vaginosis-Associated Bacterium 2) sequence
- Candida albicans
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov
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- Candida krusei
- Candida glabrata
- Trichomonas vaginalis
# C Type of Test:
The NATtrol BD MAX Vaginal Panel External Controls are intended for in vitro diagnostic use as external assayed quality control materials to monitor the qualitative amplification, detection and identification steps of the laboratory nucleic acid test, the BD MAX Vaginal Panel.
# III Intended Use/Indications for Use:
# A Intended Use(s):
See Indications for Use below.
# B Indication(s) 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 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 MAX System. This product is not intended to replace manufacturer controls provided in the package insert.
# C Special Conditions for Use Statement(s):
Rx - For Prescription Use Only
# D Special Instrument Requirements:
NATtrol BD MAX Vaginal Panel External Controls are intended for use on the BD MAX System.
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#### IV Device/System Characteristics:
##### A 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.
##### B Principle of Operation:
Contains organism targets for the BD Vaginal Panel Assay to monitor the performance of the assay over time, as performed on the BD MAX System.
#### V Substantial Equivalence Information:
##### A Predicate Device Name(s):
BD MAX CT/GC/TV 20-Day QC Panel
##### B Predicate 510(k) Number(s):
K181683
##### C Comparison with Predicate(s):
| Device & Predicate Device(s): | K201403 | K181683 |
| --- | --- | --- |
| Device Trade Name | NATrol BD MAX Vaginal Panel External Run Controls | BD MAX CT/GC/TV 20-Day QC Panel |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | NATrol BV Negative Control (NATBVNEG-BD) is intended for use as an assayed quality control material to monitor the performance of in vitro | 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 |
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| | 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 | 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. |
| --- | --- | --- |
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| | 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 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. | |
| --- | --- | --- |
| Composition | Inactivated microorganisms | Same |
| Test System | BD MAX System | Same |
| Assay Steps Monitored | Extraction, amplification, and detection | Same |
| Analytes | Inactivated | Same |
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| | microorganisms | |
| --- | --- | --- |
| General Device Characteristic Differences | | |
| Physical Format | Read-to-use liquid | Lyophilized |
| Number of Targets Monitored | Eight (8): *Lactobacillus jensenii*, *Gardnerella vaginalis*, *Atopobium vaginae*, *Saccharomyces cerevisiae*, *Candida albicans*, *Candida krusei*, *Candida glabrata*, and *Trichomonas vaginalis* | Three (3): *Chlamydia trachomatis*, *Neisseria gonorrhoeae* and *Trichomonas vaginalis* |
# **VI Standards/Guidance Documents Referenced:**
Special Controls under 21 CFR 866.3920
# **VII Performance Characteristics (if/when applicable):**
# **A Analytical Performance:**
# 1. Precision/Reproducibility:
An external site precision study was performed with the NATtrol BD MAX Vaginal Panel External Run Controls on the BD Max system. 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 (NATBVPOS-BD), two (2) lots of BV Negative (NATBVNEG-BD), and one (1) lot of CTV Positive (NATCTVPOS-BD) controls. All controls were added to the BD Molecular Swab Sample Buffer Tube and processed according to the BD Vaginal Panel Assay package insert. A total of 381 external controls were tested (86 BV Positive Controls, 104 CTV Positive Controls, and 191 BV Negatives). The results are shown in the Tables below:
Table 1: BV Positive Control Precision Study Summary
| BV Positive Control | | |
| --- | --- | --- |
| Target | BD MAX Result (Observed/Total) | % Agreement with expected Results (95% CI) |
| BV | Positive (84/86) | 97.7% (91.9%-99.4%) |
| C group | Negative (86/86) | 100% (95.7%-100%) |
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| 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%) |
Table 2: BV Negative Control Precision Study Summary
| BV Negative Control | | |
| --- | --- | --- |
| Target | BD MAX Result (Observed/Total) | % Agreement with expected Results (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%) |
Table 3: Candida/TV Positive Control Precision Study Summary
| Candida/TV Positive Control | | |
| --- | --- | --- |
| Target | BD MAX Result (Observed/Total) | % Agreement with expected Results (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%) |
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Table 4: BV Positive Control Precision Study Stratified by Operator and Lot
| | Lot Number | | |
| --- | --- | --- | --- |
| Operator | 320306 | 322104 | Total |
| 1 | 0/0 | 5/5 (100%) | 5/5 (100%) |
| 2 | 12/12 (100%) | 3/3 (100%) | 15/15 (100%) |
| 3 | 0/0 | 3/3 (100%) | 3/3 (100%) |
| 4 | 3/3 (100%) | 12/12 (100%) | 15/15 (100%) |
| 5 | 3/3 (100%) | 43/45 (95.55%) | 46/48 (95.8%) |
| Total | 18/18 (100%) | 66/68 (97.05%) | 84/86 (97.7%) |
Table 5: Candida/TV Positive Control Precision Study Stratified by Operator
| | Lot Number | |
| --- | --- | --- |
| Operator | 322106 | Total |
| 1 | 5/5 (100%) | 5/5 (100%) |
| 2 | 9/9 (100%) | 9/9 (100%) |
| 3 | 3/4 (75%) | 3/4 (75%) |
| 4 | 15/15 (100%) | 15/15 (100%) |
| 5 | 67/68 (98.5%) | 67/68 (98.5%) |
| 6 | 3/3 (100%) | 3/3 (100%) |
| Total | 102/104 (98.1%) | 102/104 (98.1%) |
Table 6: BV Negative Control Precision Study Stratified by Operator and Lot
| | Lot Number | | |
| --- | --- | --- | --- |
| Operator | 322123 | 321575 | Total |
| 1 | 10/10 (100%) | 0/0 | 10/10 (100%) |
| 2 | 12/12 (100%) | 12/12 (100%) | 24/24 (100%) |
| 3 | 7/7 (100%) | 0/0 | 7/7 (100%) |
| 4 | 27/27 (100%) | 3/3 (100%) | 30/30 (100%) |
| 5 | 112/114 (98.2%) | 3/3 (100%) | 115/117 (98.3%) |
| 6 | 3/3 (100%) | 0/0 | 3/3 (100%) |
| Total | 171/173 (98.8%) | 18/18 (100%) | 189/191 (99.0%) |
The precision study results establish there is no significant difference in control performance among different operators and between lots.
Table 7: NATrol BD MAX Vaginal Panel External Run Controls Precision Study Stratified By Lot
| Target (Lot) | External Run Control | N | Mean Ct | Ct SD | Ct %CV |
| --- | --- | --- | --- | --- | --- |
| BV-GV (320306) | NATBVPOS-BD | 18 | 21.1 | 0.30 | 1.4% |
| BV-GV (322104) | | 66 | 21.0 | 0.42 | 2.0% |
| BV-GV (All) | | 84 | 21.0 | 0.40 | 1.9% |
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| BV-Atopobium vaginae (320306) | NATBVPOS-BD | 18 | 19.7 | 0.35 | 1.8% |
| --- | --- | --- | --- | --- | --- |
| BV-Atopobium vaginae (322104) | | 66 | 21.4 | 0.47 | 2.2% |
| BV-Atopobium vaginae (All) | | 84 | 21.0 | 0.82 | 3.9% |
| Lactobacillus spp. (320306) | NATBVPOS-BD | 17 | 30.7 | 1.38 | 4.5% |
| Lactobacillus spp. (322104) | | 66 | 25.7 | 0.76 | 2.9% |
| Lactobacillus spp. (All) | | 83 | 26.7 | 2.21 | 8.3% |
| BVAB-2 (320306) | NATBVPOS-BD | 18 | 22.5 | 0.19 | 0.9% |
| BVAB-2 (322104) | | 66 | 22.2 | 0.24 | 1.1% |
| BVAB-2 (All) | | 84 | 22.3 | 0.25 | 1.1% |
| TV (322106) | NATCVPOS-BD | 102 | 26.1 | 0.26 | 1.0% |
| C group (322106) | | 102 | 25.2 | 0.40 | 1.6% |
| C. krusei (322106) | | 102 | 25.2 | 0.34 | 1.3% |
| C. glabrata (322106) | | 102 | 30.1 | 2.11 | 7.0% |
| Lactobacillus spp. (321575) | NATBVNEG-BD | 18 | 23.7 | 0.22 | 0.9% |
| Lactobacillus spp. (322123) | | 171 | 22.5 | 0.44 | 1.9% |
| Lactobacillus spp. (All) | | 189 | 22.6 | 0.56 | 2.5% |
The results confirm there is no significant difference in Ct values for controls between different lots of BV Positive Controls and BV Negative Controls.
Overall, the precision study results are acceptable.
2. Linearity:
Not applicable.
3. Analytical Specificity/Interference:
Not applicable.
4. Assay Reportable Range:
Not applicable.
5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):
Real-Time Stability Program:
The NATtrol BD MAX Vaginal Panel External Controls stability study is an ongoing study designed to support a 12-month shelf-life claim at 2-8°C. Testing is performed at multiple timepoints within the anticipated shelf-life with an additional test performed at least four (4) months after the proposed expiration date. The BD MAX Vaginal Panel will be used to test each control three times at each time point according to the package insert instructions for use. Acceptance criteria for each test is a positive or negative result for the appropriate targets at all time points.
The controls were tested using the BD MAX Vaginal Panel with the UVE Sample Buffer Tube for initial stability testing. Release testing (post dispense and assembly) of each lot served as the initial time point of the study (T0). For Real-Time Stability, controls in their
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final packaging were placed at 2-8°C, and three replicates (n = 3) from three separate tubes were tested at each time point per the testing methods. All three replicates for each control produced the same expected result, which is summarized in Table 8.
Table 8: Summary of Initial Real Time Stability Testing
| NATrol BD MAX Vaginal Panel External Controls | Lot | Final time point (months) | Summary of Results at Each Time Point |
| --- | --- | --- | --- |
| NATBVPOS-BD | 316984 | 12 | BV POS |
| | 318513 | 25 | |
| | 319891 | 25 | |
| | 320306 | 25 | |
| | 321997 | 18 | |
| | 322104 | 18 | |
| NATBVNEG-BD | 320307 | 25 | Cgroup POS, Ckru POS, Cgla POS, TV POS |
| | 321575 | 24 | |
| | 322123 | 18 | |
| NATCTVPOS-BD | 318697 | 13 | BV NEG |
| | 319920 | 13 | |
| | 320966 | 13 | |
| | 322106 | 18 | |
Real-time stability study protocols, acceptance criteria, and initial results were reviewed and found to be acceptable.
6. Detection Limit:
Not applicable.
7. Assay Cut-Off:
Not applicable.
### B Comparison Studies:
1. Method Comparison with Predicate Device:
Not applicable.
2. Matrix Comparison:
Not applicable.
### C Clinical Studies:
1. Clinical Sensitivity:
Not applicable.
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2. Clinical Specificity:
Not applicable.
3. Other Clinical Supportive Data (When 1. and 2. Are Not Applicable):
Not applicable.
# D Clinical Cut-Off:
Not applicable.
# E Expected Values/Reference Range:
NATrol BD MAX Vaginal Panel External Run Controls are qualitative controls, and the expected results are listed in Table 9.
Table 9: Expected Results for Each NATrol BD MAX Vaginal Panel External Control
| Target | BV Positive Control | BV Negative Control | CTV Positive Control |
| --- | --- | --- | --- |
| BV | Positive | Negative | Negative |
| C. group | Negative | Negative | Positive |
| C. krusei | Negative | Negative | Positive |
| C. glabrata | Negative | Negative | Positive |
| TV | Negative | Negative | Positive |
# VIII Proposed Labeling:
The labeling supports the finding of substantial equivalence for this device.
# IX Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
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