(111 days)
Mission CliniCheck Controls is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the following analytes: Acetaminophen, Acid Phosphatase (Total), Alanine Aminotransferase (ALT/GPT), Albumin, Alkaline Phosphatase (ALP), Alpha-1 Anti-Trypsin, Alpha Fetoprotein, Alpha Hydroxybutyrate Dehydrogenase (α-HBDH), Amylase, Apolipoprotein A-1 (APO-A1), Aspartate Aminotransferase (AST/GOT), Bilirubin (Direct), Bilirubin (Total), C3 Complement, C4 Complement, Calcium, Carbon Dioxide (CO2), Carcinoembryonic Antigen (CEA), Ceruloplasmin, Chloride, Cholesterol (Total), HDL- Cholesterol, LDL-Cholesterol, Cholinesterase, Creatine Kinase (CK), Creatinine, Digoxin, Gamma Glutamyltransferase (GGT), Glucose, Haptoglobin, Immunoglobulin A (IgA), Immunoglobulin G (IgG), Immunoglobulin M (IgM), Iron, Iron-Binding Capacity, Total (TIBC), Iron-Binding Capacity, Unsaturated (UIBC), Lactate (Lactic acid), Lactate Dehydrogenase (LDH), Lipase, Lithium, Magnesium, Phosphorus, Potassium, Protein-Total, Salicylate, Sodium, T3 Free, T3 Total, T4 Free, T4 Total, Thyroid Stimulating Hormone (TSH), Transferrin, Triglycerides, Urea Nitrogen, and Uric Acid on instruments listed in the expected values chart.
Mission CliniCheck Assayed Chemistry Control is a human serum based product containing constituents of purified biochemicals (tissue extracts of human and animal origin), chemicals, therapeutic drugs, preservatives and stabilizers. Two levels of Control are provided in a lyophilized form. Each level is packaged into a glass amber bottle containing 5mL of product. The product is packaged in single level boxes (12 x 5mL) or multiple level boxes (6 x 2 x 5mL) and stored at 2 - 8°C.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Mission CliniCheck Assayed Chemistry Control device:
Important Note: The provided document is a 510(k) summary for an Assayed Quality Control Material. This type of device is used to monitor the performance of laboratory tests, not to perform diagnostic tests directly on patients. Therefore, the "acceptance criteria" and "study" described are centered around the performance of the control material (its stability and value assignment) and its equivalence to a predicate control device, rather than the diagnostic accuracy or clinical utility of a medical device that generates results on patient samples. Many of the requested categories in your prompt (e.g., number of experts, adjudication, MRMC studies, standalone performance, training set) are typically relevant for AI/imaging diagnostic devices and are not applicable to the type of device described here.
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature/Criterion | Acceptance Criteria (Implied from testing methods) | Reported Device Performance |
|---|---|---|
| Value Assignment | Lot-to-lot variation determined by testing new lot vs. previous lot, normalized to a serum standard (NIST or OEM). Target values within a defined range. | Target values are obtained by testing 16 replicates (4 replicates over 4 days). The average of these 16 data points is the mean. The range is determined by multiplying the mean by ± 20%. All testing is performed alongside Original Equipment Manufacturer (OEM) material to verify values before accepting new ranges. |
| Shelf Life Stability | Supports a 2-year shelf life when stored at 2-8°C. | Accelerated (high temperature) stress test was conducted, and results support a 2-year shelf life when stored at 2-8°C. |
| Reconstituted Stability | Stable for up to 20 days at -20°C (frozen). | Testing showed reconstituted controls are stable for up to 20 days at -20°C. |
| In-use Stability (Refrigerated) | Stable for 7 days when stored at 2-8°C, with specific exceptions. | Values are stable for 7 days when stored at 2-8°C (tightly capped) with the following exceptions: Acid Phosphatase will be stable for 3 days, AST for 1 day, CK, LDH, T4 free and TSH for 6 days. (Note: The document implies these specific stabilities meet the acceptance criteria for those analytes). |
| Material Safety (Human Source) | Found negative for specific infectious agents. | All human source material was tested and found negative by FDA approved methods for HBsAg, HCV, and HIV-1/2. |
| Substantial Equivalence | Demonstrates substantial equivalence to the predicate device in composition, intended use, packaging, storage, and shelf life. | The conclusion states that based on the submitted results, the device "claims substantial equivalence to the predicate device in Composition... Intended use, Packaging, Storage, and Shelf life." This implies that the performance in the aforementioned areas was found to be comparable or equivalent to the predicate, as required for 510(k) clearance. |
Study Description:
The study proving the device meets the acceptance criteria is primarily an internal validation study and comparative analysis against a predicate device and known standards.
The key aspects of the study include:
- Value Assignment Study: This involves preparing a new lot of the control material and characterizing its analyte concentrations.
- Methodology: 16 replicates (4 replicates each over 4 days) are tested. The mean of these 16 data points establishes the target mean value. A range of ±20% of the mean defines the acceptable limits for control performance.
- Comparative Element: Testing is performed alongside OEM material to verify values. Lot-to-lot variation is determined by comparing the new lot to a previous lot, normalized to a serum standard (NIST or OEM).
- Stability Studies: These evaluate how the control material performs under different storage conditions and over time.
- Shelf Life: An accelerated (high temperature) stress test was conducted to project and support the 2-year shelf life.
- Reconstituted Stability: Testing determined stability for 20 days when frozen at -20°C.
- In-use Stability: Testing determined stability for 7 days when refrigerated at 2-8°C, with specific shorter stabilities noted for certain analytes.
- Safety Testing: All human source material was tested for infectious agents (HBsAg, HCV, HIV-1/2) using FDA-approved methods.
- Comparison to Predicate Device: A detailed comparison was made between the new device and the predicate device (K103364) across various attributes like name, 510(k) number, intended use, matrix, form, levels, storage, reconstituted stability, shelf life, and packaging. The key difference was the expanded list of analytes the new device is assayed for, indicating the device meets the performance for these additional analytes.
2. Sample Size used for the test set and the data provenance:
- Sample Size for Value Assignment (Test Set): 16 replicates were used for each analyte to establish the mean and range for value assignment.
- Data Provenance: The data is generated internally by Diamond Diagnostics, Inc., as part of their manufacturing and quality control processes. The document does not specify the country of origin for the data, but the company is located in Holliston, MA, USA, and the submission is to the FDA, implying studies conform to US regulatory standards. The studies conducted are prospective for the specific lot being validated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This question is not applicable to this type of device. The "ground truth" for a quality control material is established through precise analytical measurements using calibrated instruments and reference materials (like NIST standards) or comparison to existing validated OEM materials. It does not involve human expert interpretation in the way that, for example, a diagnostic imaging device would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. As described above, the "truth" for this control material is based on analytical measurements, not subjective human judgment requiring adjudication.
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 is a quality control material, not an AI-powered diagnostic device involving human readers or interpretation of clinical cases.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is not an algorithm or AI-based device. Its "performance" is its intrinsic analytical characteristics and stability, which are measured directly.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the control material's analyte concentrations is established by:
- Analytical Measurement: Precise quantitative measurement of analytes using laboratory instrumentation.
- Reference Materials: Normalization to NIST (National Institute of Standards and Technology) comparable standards or Original Equipment Manufacturer (OEM) materials.
- Comparison to Predicate/Previous Lots: Ensuring consistency and comparability with previously validated lots and the predicate device.
8. The sample size for the training set:
Not applicable. This device is not an AI/machine learning model and therefore does not have a "training set" in that context. The "value assignment" process involves establishing the characteristics of each new lot, which is analogous to a validation step for that specific lot, rather than training a model.
9. How the ground truth for the training set was established:
Not applicable, as there is no "training set" for this device.
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.