(48 days)
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 OC Panel are not intended to replace manufacturer controls provided with the device.
The BD MAX™ Enteric Parasite Control Panel and the BD MAX™ Enteric Parasite 20-Day QC Panel are used to monitor the extraction, amplification of the BD MAX™ Enteric Parasite Panel. Both panels contain individually packaged pellets consisting of inactivated, Cryptosporidium parvum, Giardia lamblia, and a recombinant Escherichia coli. The BD MAX™ Enteric Parasite Control Panel and the BD MAX™ Enteric Parasite 20-Day QC Panel differ only by packaged quantity. Each BD MAX™ Enteric Parasite Control Panel consists of 6 individually packaged positive control pellets. Each BD MAX™ Enteric Parasite 20-Day QC Panel consists of 20 individually packaged positive control pellet is individually wrapped with a desiccant in a heat-sealed foil pouch. The organisms are prepared in a buffered solution with materials of animal origin, preservatives and stabilizers. The solution is lyophilized into a ready-to-use pellet containing inactivated orqanism(s) is packaged in a 2.0-ml labeled micro-centrifuge tube with a red screw cap.
The BD MAX™ Enteric Parasite Control Panel and the BD MAX™ Enteric Parasite 20-Day QC Panel do not contain negative controls.
Here's a breakdown of the acceptance criteria and study information for the BD MAX™ Enteric Parasite Control Panel and BD MAX™ Enteric Parasite 20-Day QC Panel, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" through numerical thresholds for precision and reproducibility in a tabular format. However, the study focuses on agreement for detecting the target analytes. Based on the results, the implied acceptance criterion is 100% agreement for the detection of each analyte.
| Analyte | Acceptance Criteria (Implied) | Reported Device Performance (Overall Agreement) |
|---|---|---|
| G. lamblia | 100% agreement | 100% (90/90) |
| E. histolytica | 100% agreement | 100% (90/90) |
| C. parvum | 100% agreement | 100% (90/90) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set:
- For each analyte (G. lamblia, E. histolytica, C. parvum): 90 tests total (30 tests per site x 3 sites).
- The study involved testing 3 different lots of controls, by 6 different operators (2 per facility), over 5 days. Each operator performed 3 tests per day (1 per lot).
- Calculations: 3 Lots x 6 Operators x 5 Days = 90 tests.
- Data Provenance: The document does not explicitly state the country of origin. It indicates "three different testing locations" were used, implying it was a multi-site study. It's a prospective study looking at the performance of the control panels.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. For a quality control material, the "ground truth" is typically established by the known composition of the control material (i.e., it contains the specified inactivated organisms/recombinant E. coli). The study is evaluating if the device (BD MAX™ Enteric Parasite Panel on the BD MAX™ System) correctly detects these known components when the control is run.
4. Adjudication Method for the Test Set
This information is not provided in the document. Given the nature of a quality control study for a qualitative detection assay, an "adjudication method" in the typical sense (e.g., for disagreements among human readers) is less applicable. The "results" are the output of the BD MAX™ System (detection or non-detection of the target analytes). The document notes retesting occurred for "Incomplete Run errors" and "Unresolved result," which serves as an internal resolution mechanism rather than an adjudication among independent interpreters.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study typically compares human reader performance (with and without AI assistance) on diagnostic images or complex cases. This document describes a performance study for a diagnostic quality control material, which does not involve human readers interpreting results in the same way.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, a standalone performance evaluation of the control panel with the BD MAX™ Enteric Parasite Panel and System was conducted. The study assesses the ability of the automated system to detect the known components within the control panel. While human operators initiate the tests, the performance reported (detection of G. lamblia, E. histolytica, C. parvum) is the output of the automated BD MAX™ system, without human interpretation influencing the final "positive" or "negative" call for the presence of the analytes.
7. The Type of Ground Truth Used
The ground truth used is the known composition of the control material. The control panels are manufactured to contain specific inactivated organisms (Cryptosporidium parvum, Giardia lamblia) and recombinant Escherichia coli (as a surrogate for E. histolytica). The "ground truth" is that these analytes are present in the control panels. The study verifies if the BD MAX™ System correctly identifies their presence.
8. The Sample Size for the Training Set
This information is not applicable/not provided for this specific document. This document describes the performance of a quality control material for a previously cleared diagnostic system (BD MAX™ Enteric Parasite Panel on the BD MAX™ System). Quality control materials themselves are not typically "trained" like AI algorithms. The underlying BD MAX™ system and its assays would have had their own development and validation, which might involve training data, but that is not the subject of this 510(k) for the control panels.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided (see point 8).
§ 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.”