BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel

K181711 · Microbiologics, Inc. · PMN · Aug 15, 2018 · Microbiology

Device Facts

• Record ID: K181711
• Device Name: BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel
• Applicant: Microbiologics, Inc.
• Product Code: PMN · Microbiology
• Decision Date: Aug 15, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3920
• Device Class: Class 2

Indications for Use

The BD MAX™ Enteric Parasite Control Panel and the BD MAX™ Enteric Parasite 20-Day QC Panel are intended for use as external assayed positive quality control materials to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Cryptosporidium parvum, Giardia lamblia, and Entamoeba histolytica performed with the BD MAX™ Enteric Parasite Panel on the BD MAX™ System. The controls comprise cultured and inactivated C. parvum, G. lamblia and recombinant Escherichia coli. The E. coli carries a plasmid which is a surrogate control material for detection of E. histolytica. The BD MAX™ Enteric Parasite Control Panel and BD MAX™ Enteric Parasite 20-Day QC Panel are not intended to replace manufacturer controls provided with the device.

Device Story

External assayed quality control material; monitors performance of BD MAX Enteric Parasite Panel (K143648) on BD MAX System. Input: lyophilized pellets containing inactivated C. parvum, G. lamblia, and recombinant E. coli (plasmid surrogate for E. histolytica). Operation: pellets processed via BD MAX System DNA extraction, amplification, and detection workflows. Output: qualitative positive results for target analytes. Used in clinical laboratory settings by trained personnel. Provides verification of assay performance; ensures reliability of patient test results; does not replace manufacturer-provided controls.

Clinical Evidence

Precision and reproducibility study conducted across 3 sites with 6 operators using 3 lots over 5 days. Total of 90 tests performed per analyte. Results showed 100% agreement (90/90) for G. lamblia, E. histolytica, and C. parvum. No clinical data; bench testing only.

Technological Characteristics

Lyophilized pellets in 2.0-ml micro-centrifuge tubes. Composition: inactivated C. parvum, G. lamblia, and recombinant E. coli in buffered solution with animal-origin materials, preservatives, and stabilizers. Ready-to-use format. No negative controls included.

Indications for Use

Indicated for use as external positive quality control materials for in vitro nucleic acid testing of Cryptosporidium parvum, Giardia lamblia, and Entamoeba histolytica using the BD MAX Enteric Parasite Panel. Not intended to replace manufacturer-provided controls.

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

• Bio-Rad Amplichek II (DEN150058)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE

A. 510(k) Number:
K181711

B. Purpose for Submission:
To obtain a substantial equivalence determination for the BD MAX Enteric Parasite Control Panel and BD MAX Enteric Parasite 20-Day QC Panel.

C. Measurand:
Multi-analyte quality control panel

D. Type of Test:
External assayed quality control material used to monitor the performance of the BD MAX Enteric Parasite Assay (K143648) for the qualitative detection of *Cryptosporidium parvum*, *Giardia lamblia* and *Entamoeba histolytica* in formalin-fixed stool specimens.

E. Applicant:
Microbiologics, Inc.

F. Proprietary and Established Names:
BD MAX Enteric Parasite Control Panel
BD MAX Enteric Parasite 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)

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3. Product code:

PMN: Assayed external control material for microbiology nucleic acid amplification (NAT) assays

4. Panel:

83-Microbiology

H. Intended Use:

1. Intended use(s):

The BD MAX Enteric Parasite Control Panel and the BD MAX Enteric Parasite 20-Day QC Panel are intended for use as external assayed positive quality control materials to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Cryptosporidium parvum, Giardia lamblia, and Entamoeba histolytica performed with the BD MAX Enteric Parasite Panel on the BD MAX System. The controls comprise cultured and inactivated C. parvum, G. lamblia and recombinant Escherichia coli. The E. coli carries a plasmid which is a surrogate control material for detection of E. histolytica.

The BD MAX Enteric Parasite Control Panel and BD MAX Enteric Parasite 20-Day QC Panel are 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.

For prescription use only.

This product is not intended to replace manufacturer controls provided with the BD MAX Enteric Parasite Panel.

4. Special instrument requirements:

BD MAX System with the BD MAX Enteric Parasite Panel

I. Device Description:

The BD MAX Enteric Parasite Control Panel and BD MAX Enteric Parasite 20-Day QC Panel comprise invidually packaged lyophilized pellets that each contain inactivated Cryptosporidium parvum, Giardia lamblia and a recombinant strain of Escherichia coli that

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carries a plasmid containing an Entamoeba histolytica gene fragment, as well as preservatives/stabilizers. The pellets are formulated to contain the target analytes at specific concentrations as determined by quantitative PCR. The two panels differ only in terms of the number of individually packaged controls contained within each control set (6 vs 20). Negative controls are not included in either 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:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| | BD MAX Enteric Parasite Control Panel BD MAX Enteric Parasite 20-Day QC Panel (K181711) | Amplichek II (DEN150058) |
| Intended Use | The BD MAX Enteric Parasite Control Panel and the BD MAX Enteric Parasite 20-Day QC Panel are intended for use as external assayed positive quality control materials to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Cryptosporidium parvum, Giardia lamblia, and Entamoeba histolytica performed with the BD MAX Enteric Parasite Panel on the BD MAX System. The controls comprise cultured and inactivated C. parvum, G. | 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 |

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| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| | BD MAX Enteric Parasite Control Panel BD MAX Enteric Parasite 20-Day QC Panel (K181711) | Amplichek II (DEN150058) |
| | lamblia and recombinant Escherichia coli. The E. coli carries a plasmid which is a surrogate control material for detection of E. histolytica. The BD MAX Enteric Parasite Control Panel and BD MAX Enteric Parasite 20-Day QC Panel are not intended to replace manufacturer controls provided with the device. | listed in the Representative Results Chart in this labeling. |
| Control Format | Cultured and inactivated organisms | Same |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| | BD MAX Enteric Parasite Control Panel BD MAX Enteric Parasite 20-Day QC Panel (K181711) | Amplichek II (DEN150058) |
| Target Analytes | • Cryptosporidium parvum • Giardia lamblia • Entamoeba histolytica | • Methicillin Resistant Staphylococcus aureus • Methicillin Sensitive Staphylococcus aureus • Clostridium difficile Vancomycin-resistant Enterococci |
| Control Format | Cultured and inactivated parasites and recombinant Escherichia coli (surrogate for E. histolytica) | Cultured and inactivated bacteria |
| Instrument System | BD MAX System | Cepheid GeneXpert |

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| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| | BD MAX Enteric Parasite Control Panel
BD MAX Enteric Parasite 20-Day QC Panel (K181711) | Amplichek II (DEN150058) |
| | | Systems |
| Assay Compatibility | • BD MAX Enteric Parasite Panel (K143648) | • Cepheid Xpert MRSA/SA Blood Culture Assay (K130894)
• Cepheid Xpert MRSA (K070462)
• Cepheid Xpert SA Nasal Complete (K100822)
• Cepheid Xpert MRSA/SA SSTI (K080837)
• Cepheid Xpert C. difficile (K091109)
• Cepheid Xpert C. difficile/Epi (K110203)
• Cepheid Xpert vanA (K092953) |

## 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.

CLSI. Evaluation of Precision of Quantitative Measurement Procedures: Approved Guideline – Third Edition. CLSI Document EP05-A3. Wayne, PA: Clinical and Laboratory Standards Institute; 2014.

## L. Test Principle:

The BD MAX Enteric Parasite Control Panel and BD MAX Enteric Parasite 20-Day QC Panel are intended for use as external assayed quality control materials for use in monitoring the DNA extraction, amplification and detection processes associated with the BD MAX Enteric Parasite Panel (K143648) performed on the BD MAX System.

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# M. Performance Characteristics (if/when applicable):

# 1. Analytical performance:

# a. Precision/Reproducibility:

The reproducibility of results obtained with the BD MAX Enteric Parasite control panels was evaluated in a study performed at three sites over five days, with two operators per site. Each operator tested three lyophilized control pellets on each day of the study according to the instructions for use (3 sites x 5 days x 2 operators x 3 replicates = 90 replicates 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 (not provided in the BD MAX Enteric Parasite Control and 20-Day QC Panels) was also tested at least once a day on each instrument to monitor for contamination. The results of the study are summarized in Table 1. All Negative Controls and produced the expected results.

Table 1. Summary of results from the Reproducibility Study

| Analyte | Agreement (%) by Control Lot | | | |
| --- | --- | --- | --- | --- |
| | Lot 1 | Lot 21 | Lot 32 | Overall |
| G. lamblia | 30/30 | 30/30 | 30/30 | 90/90 |
| | (100) | (100) | (100) | (100) |
| E. histolytica | 30/30 | 30/30 | 30/30 | 90/90 |
| | (100) | (100) | (100) | (100) |
| C. parvum | 30/30 | 30/30 | 30/30 | 90/90 |
| | (100) | (100) | (100) | (100) |
| Analyte | Agreement (%) by Test Site/BD MAX System | | | |
| | Site 13 | Site 24 | Site 3 | Overall |
| G. lamblia | 30/30 | 30/30 | 30/30 | 90/90 |
| | (100) | (100) | (100) | (100) |
| E. histolytica | 30/30 | 30/30 | 30/30 | 90/90 |
| | (100) | (100) | (100) | (100) |
| C. parvum | 30/30 | 30/30 | 30/30 | 90/90 |
| | (100) | (100) | (100) | (100) |

An Incomplete Run error occurred with one control; a new control was retested and the expected results were obtained
2 An Incomplete Run error occurred with one control and another produced and Unresolved result; in both cases, a new control was retested and produced the expected results
3 Two Incomplete Run errors occurred; in both cases a new control was retested and the expected results were obtained
4 An Unresolved result was obtained with one control; a new control was retested and the expected results were obtained

The reproducibility of the BD MAX Enteric Parasite Control and 20-Day QC Panels within and between sites/BD MAX Systems and operators and within and between lots was determined to be acceptable.

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b. Linearity/assay reportable range:

Not applicable.

c. Traceability, Stability, Expected values (controls, calibrators, or methods):

**Stability**

Reagent shelf-life was established in an Accelerated Stability Study that was performed with three lots of BD MAX Enteric Parasite Panel controls that were placed at 43, 53 or 63°C for up to 42 days. All results were as expected and there was no evidence of product degradation under the conditions tested. The results of this study were used to support a claimed shelf-life of 18 months at 2-25°C, which will be verified through a Real-time Stability Study.

**Expected Values**

The BD MAX Enteric Parasite Control and 20-Day QC Panels are expected to produce positive results for G. lamblia, C. parvum and E. histolytica when tested with the BD MAX Enteric Parasite Panel on the BD MAX System.

d. Detection limit:

Not applicable.

e. Analytical specificity:

Not applicable.

f. Assay cut-off:

Not applicable.

2. Comparison studies:

a. Method comparison with predicate device:

Not applicable.

b. Matrix comparison:

Not applicable.

3. Clinical studies:

a. Clinical Sensitivity:

Not applicable.

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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.

5. Expected values/Reference range:

The BD MAX Enteric Parasite Control Panel and BD MAX Enteric Parasite 20-Day QC Panel do not have assigned values. Performance was evaluated through testing at three sites using three different BD MAX Systems and three lots of controls (refer to Section M(1)(a)).

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.