K181683 · Microbiologics, Inc. · PMN · Aug 28, 2018 · Microbiology
Device Facts
Record ID
K181683
Device Name
BD MAX CT/GC/TV 20-Day QC Panel
Applicant
Microbiologics, Inc.
Product Code
PMN · Microbiology
Decision Date
Aug 28, 2018
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 866.3920
Device Class
Class 2
Indications for Use
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. qonorrhoeae and T. vaqinalis. The BD MAX CT/GC/TV™ 20-Day QC Panel is not intended to replace manufacturer controls provided with the device.
Device Story
The BD MAX™ CT/GC/TV 20-Day QC Panel provides external positive quality control for clinical laboratory nucleic acid testing. The device consists of 20 individually packaged lyophilized pellets containing inactivated Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis. Laboratory personnel process the control pellet like a patient sample within the BD MAX™ System. The system performs extraction, amplification, and detection of the target pathogens. The output is a qualitative result used by the healthcare provider to verify the performance of the assay and the instrument. This monitoring ensures the reliability of patient test results, helping clinicians accurately diagnose these infections.
Clinical Evidence
Precision and reproducibility study conducted across three testing sites using six operators and three lots over five days. Testing performed on BD MAX™ instruments using the BD MAX™ CT/GC/TV assay. Results showed high agreement: C. trachomatis 100% (90/90), N. gonorrhoeae 99% (89/90), and T. vaginalis 100% (90/90). Three unresolved results were resolved upon retesting.
Technological Characteristics
Lyophilized pellet containing inactivated C. trachomatis, N. gonorrhoeae, and T. vaginalis. Packaged in 2.0ml micro-centrifuge tubes. Designed for use with the BD MAX™ System for nucleic acid extraction, amplification, and detection. No negative control included.
Indications for Use
Indicated 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 using the BD MAX™ CT/GC/TV Assay on the BD MAX™ System.
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.”
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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
A. 510(k) Number:
K181683
B. Purpose for Submission:
To obtain a substantial equivalence determination for the BD MAX CT/GC/TV 20-Day QC Panel.
C. Measurand:
Nucleic acids from inactivated *Chlamydia trachomatis*, *Neisseria gonorrhoeae*, and *Trichomonas vaginalis*
D. Type of Test:
The BD MAX CT/GC/TV 20-Day QC Panel is an external assayed positive quality control material designed to monitor the performance of *in vitro* laboratory nucleic acid testing procedures for the qualitative detection of *Chlamydia trachomatis*, *Neisseria gonorrhoeae*, and *Trichomonas vaginalis* in genitourinary specimens.
E. Applicant:
Microbiologics, Inc.
F. Proprietary and Established Names:
Trade Name: BD MAX CT/GC/TV 20-Day QC Panel
G. Regulatory Information:
1. Regulation section:
21 CFR 866.3920, Assayed quality control material for clinical microbiology assays
2. Classification:
Class II (Special Controls)
3. Product code:
PMN
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4. Panel:
(83) Microbiology
# H. Intended Use:
1. Intended use:
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 performed with the BD MAX CT/GC/TV Assay on the BD MAX System. This product is not intended to replace manufacturer controls provided with the device. The controls comprise cultured and inactivated C. trachomatis, N. gonorrhoeae and T. vaginalis organisms. The BD MAX CT/GC/TV 20-Day QC Panel is not intended to replace manufacturer controls provided with the device.
2. Indication(s) for use:
Same as Intended Use.
3. Special conditions for use statement(s):
For in vitro diagnostic use only
For prescription use only
3. Special instrument requirements:
The BD MAX CT/GC/TV 20-Day QC Panel is intended for use on the BD MAX Instrument.
# I. Device Description:
The BD MAX CT/GC/TV 20-Day QC Panel is a quality control material provided to the customer as 20 individually packaged positive control pellets. Each pellet consists of inactivated Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis microorganisms. The organisms are purified and suspended in a buffered aqueous matrix (Base Matrix), followed by inactivation by gamma radiation. The organisms are then quantified by a by quantitative PCR assay and spiked into the Base Matrix at predefined target concentrations. Aliquots of the suspension are lyophilized and packaged. Each production lot is tested for purity and is assayed for performance on the BD MAX instrument.
The pellets are contained in a vial and enclosed in a vacuum sealed foil pouch. The user opens the pouch, uncaps the tube and transfers the pellet into the BD MAX UVE Sample
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Buffer Tube. The mixture is vortexed and processed like a patient sample according to the test instructions for the BD MAX CT/GC/TV assay. Negative controls are not included in the panel.
# J. Substantial Equivalence Information:
1. Predicate device name(s):
Bio-Rad Amplichek II
2. Predicate 510(k) number(s):
DEN150058
3. Comparison with predicate:
| Characteristic | BD MAX™ CT/GC/TV 20-Day QC Panel | Predicate Device – Bio-Rad Amplichek II (DEN 150058) |
| --- | --- | --- |
| Intended Use | 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. | Amplichek II is intended for use as an external assayed quality control material to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Methicillin Resistant Staphylococcus aureus, Methicillin Sensitive Staphylococcus aureus, Clostridium difficile and Vancomycin-resistant Enterococci performed on Cepheid GeneXpert Systems. This product is not intended to replace manufacturer controls provided with the device. This product is only for use with assays and instruments listed in the Representative Results Chart in this labeling. |
| Physical Format | Lyophilized pellet | Ready-to-use liquid |
| Composition | Inactivated microorganisms | Inactivated microorganisms |
| Analytes | Chlamydia trachomatis Neisseria gonorrhoeae Trichomonas vaginalis | Methicillin Resistant Staphylococcus aureus Methicillin Sensitive Staphylococcus aureus Clostridium difficile Vancomycin-resistant Enterococci |
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| Test System | BD MAX System | Cepheid GeneXpert System |
| --- | --- | --- |
| Directions for Use | Process like patient sample | Process like patient sample |
| Assay Steps Monitored | Extraction, amplification, and detection | Extraction, amplification, detection |
| Number of Targets monitored in one assay | Multiple | Multiple |
### K. Standard/Guidance Document Referenced (if applicable):
CLSI. Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline. CLSI Document EP25-A. Wayne, PA: Clinical and Laboratory Standards Institute; 2009.
### L. Test Principle:
Not applicable; this is control material to monitor performance of a test.
### M. Performance Characteristics (if/when applicable):
#### 1. Analytical performance:
##### a. Reproducibility:
The reproducibility of results obtained with the BD MAX 20-Day QC Panel was evaluated in a study performed at three sites over five days, with two operators per site. Three lots of the control material were evaluated by testing with the BD MAX CT/GC/TV Assay on three BD MAX instruments. Each operator tested three lyophilized control pellets on each day of the study (3 sites x 5 days x 2 operators x 3 replicates (lots) = 90 measurements in total). Controls associated with incomplete instrument runs (2) or that produced unresolved results (1) were retested using a new control pellet according to the Instructions For Use. A Negative Control consisting of molecular grade water was also tested at least once a day on each instrument to monitor for contamination. The results of the study are summarized below. All Negative Controls produced the expected results.
| Analyte | Agreement (%) by Test Site/BD MAX System | | | |
| --- | --- | --- | --- | --- |
| | \( Site 1^1 \) | \( Site 2^1 \) | \( Site 3^2 \) | Overall |
| C. trachomatis | 30/30(100%) | 30/30(100%) | 30/30(100%) | 90/90(100%) |
| N. gonorrhoeae | 30/30(100%) | 30/30(100%) | 29/30(96.7%) | 89/90(98.9%) |
| T. vaginalis | 30/30(100%) | 30/30(100%) | 30/30(100%) | 90/90(100%) |
\( ^{1} \) Three Unresolved results were obtained; in all cases a new control was retested and the expected results were obtained
\( ^{2} \) One unresolved result was obtained, no retest was performed.
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The calculated average Ct score value, the associated standard deviation, and % coefficient of variation were calculated for each organism in the panel (based on results from two testing sites, the third site did not have software allowing access to the signal generated by the instrument):
| | **C. trachomatis** | **N. gonorrhoeae** | **T. vaginalis** | **IPC** |
| --- | --- | --- | --- | --- |
| **N** | 60 | 60 | 60 | 60 |
| **Mean** | 30.2 | 33.6 | 30.8 | 30.5 |
| **SD** | 0.472 | 1.086 | 0.475 | 0.365 |
| **%CV** | 1.56 | 3.23 | 1.55 | 1.09 |
b. Linearity/assay reportable range:
Not applicable
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
Traceability:
Not applicable
Stability:
1. Shelf life stability was initially determined through an accelerated study with three lots of the controls. The product was placed into chambers at elevated temperatures: 43°C, 53°C and 63°C. Each lot was tested in 4 replicates at each time point: Day 0, Day 14 and Day 42. The stability of the product was evaluated by calculating the mean Ct value at each time point for CT and for NG and comparing that to the mean Ct value obtained at Day 0. The data showed that there was no product degradation under the conditions tested. The change in Ct score, across the three lots ranged from -0.2 to 1.3 for C. trachomatis, from -0.6 to 1.6 for N. gonorrhoeae, and from -0.5 to 0.6 for T. vaginalis. The data is summarized below.
| **C. trachomatis** | | Lot 1 | | | Lot 2 | | | Lot 3 | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | 43°C | 53°C | 63°C | 43°C | 53°C | 63°C | 43°C | 53°C | 63°C |
| | Day | Ct score | Ct score | Ct score | Ct score | Ct score | Ct score | Ct score | Ct score | Ct score |
| Mean | 0 | 30.1 | 30.1 | 30.1 | 30.1 | 30.1 | 30.1 | 29.8 | 29.8 | 29.8 |
| Mean Change in Ct score | 14 | -0.1 | 0.8 | 0.5 | 0.3 | 0.4 | 1.0 | 0.6 | 1.3 | 1.0 |
| | 28 | 1.1 | -0.2 | 1.0 | 0.2 | 0.0 | 0.8 | 0.8 | 0.5 | 1.1 |
| | 42 | 0.6 | 0.1 | 0.2 | 0.9 | 0.3 | 0.6 | 0.6 | 0.4 | 0.5 |
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| N. gonorrhoeae | | Lot 1 | | | Lot 2 | | | Lot 3 | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | 43°C | 53°C | 63°C | 43°C | 53°C | 63°C | 43°C | 53°C | 63°C |
| | Day | Ct score | Ct score | Ct score | Ct score | Ct score | Ct score | Ct score | Ct score | Ct score |
| Mean | 0 | 34.0 | 34.0 | 34.0 | 34.0 | 34.0 | 34.0 | 33.8 | 33.8 | 33.8 |
| Mean Change in Ct score | 14 | 0.0 | 0.0 | -0.2 | 0.6 | 0.4 | 0.2 | 1.3 | 0.7 | 0.4 |
| | 28 | 0.7 | 0.3 | -0.4 | 0.2 | 0.7 | 0.8 | 0.1 | 0.2 | -0.4 |
| | 42 | 0.6 | -0.3 | -0.3 | 1.6 | 0.5 | 0.9 | 0.4 | 0.8 | -0.6 |
| T. vaginalis | | Lot 1 | | | Lot 2 | | | Lot 3 | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | 43°C | 53°C | 63°C | 43°C | 53°C | 63°C | 43°C | 53°C | 63°C |
| | Day | Ct score | Ct score | Ct score | Ct score | Ct score | Ct score | Ct score | Ct score | Ct score |
| Mean | 0 | 31.3 | 31.3 | 31.3 | 31.0 | 31.0 | 31.0 | 30.7 | 30.7 | 30.7 |
| Mean Change in Ct score | 14 | -0.3 | 0.3 | -0.1 | 0.5 | 0.2 | 0.4 | 0.5 | 0.6 | 0.1 |
| | 28 | 0.4 | 0.3 | 0.3 | 0.2 | 0.3 | 0.4 | 0.2 | 0.6 | 0.3 |
| | 42 | 0.0 | -0.2 | 0.0 | 0.4 | 0.1 | -0.5 | 0.6 | 0.6 | -0.2 |
A real-time shelf life stability study is in process with a goal of 24 months stability claim.
2. An in-use stability of the dissolved pellets was evaluated by keeping the hydrated pellets at room temperature (23°C) for six hours. The testing was conducted with 4 replicates at 3 and at 6 hours. The calculated % CV (based on Ct values) across all three analytes ranged from 0.16% to 1.95%, demonstrating no degradation of the product once hydrated for up to 5 hours at ambient laboratory temperature.
### Expected Values:
The BD MAX CT/GC/TV 20-Day QC Panel is a qualitative positive control expected to produce positive results for C. trachomatis, N. gonorrhoeae, and T. vaginalis.
d. Detection limit:
Not applicable.
e. Analytical Specificity:
Not applicable.
f. Assay cut-off:
Not applicable.
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2. Comparison studies:
a. Method comparison with predicate device:
Not applicable.
b. Matrix comparison:
Not applicable.
3. Clinical studies:
a. Clinical Sensitivity:
Not applicable.
b. Clinical specificity:
Not applicable.
c. Other clinical supportive data (when a. and b. are not applicable):
Not applicable.
4. Clinical cut-off:
Not Applicable.
# N. Proposed Labeling:
The labeling supports the finding of substantial equivalence for this device.
# O. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
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