(76 days)
chemTRAK® H is intended for use as a consistent test sample of known concentration for monitoring assay conditions in many clinical laboratory determinations. Include chemTRAK® H with patient serum specimens when assaying for any of the listed constituents. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.
Moni-Trol® H is intended for use as a consistent test sample of known concentration for monitoring assay conditions in many clinical laboratory determinations. Include Moni-Trol® H with patient serum specimens when assaying for any of the listed constituents. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.
This product is a liguid stable control material prepared from human serum. Analyte levels are adjusted with various animal extracts and other non-protein materials including drugs, drug metabolites and purified chemicals. Amylase, ALT/GPT, AST/GOT, CK and lipase are obtained from porcine tissue; alkaline phosphatase and GGT are from bovine tissue; LDH is from avian tissue. Preservatives and stabilizers are added to maintain product integrity.
The provided text describes a 510(k) premarket notification for assay controls, not an AI/ML device. Therefore, a significant portion of the requested information, which pertains to AI/ML device studies (e.g., sample sizes for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance), is not applicable and not present in the document.
The document discusses the substantial equivalence of the Thermo Scientific MAS® chemTRAK® H and Moni-Trol® H Liquid Assayed Chemistry Controls to previously cleared predicate devices (K030942). The acceptance criteria and "study" in this context refer to demonstrating this substantial equivalence, primarily by comparing intended use, device description, matrix, storage conditions, and analyte lists.
Here's an attempt to answer the questions based only on the provided text, indicating where information is not applicable or unavailable:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device (quality control material), the "acceptance criteria" revolve around demonstrating substantial equivalence to a predicate device, meaning it performs similarly and presents similar risks. The "reported device performance" is implicitly that it functions as a consistent test sample for monitoring assay conditions, akin to the predicate.
| Acceptance Criterion (Implicit) | Reported Device Performance (Implicit) |
|---|---|
| Intended Use is substantially equivalent to predicate. | chemTRAK® H and Moni-Trol® H are intended for use as consistent test samples of known concentration for monitoring assay conditions in many clinical laboratory determinations, and to compare observations with expected ranges for consistent reagent and instrument performance. This is identical to the predicate's intended use. |
| Device Description is substantially equivalent to predicate (liquid stable control from human serum, adjusted analyte levels with animal extracts and non-protein materials, preservatives/stabilizers). | The modified device maintains the same description: a liquid stable control material prepared from human serum, with analyte levels adjusted using various animal extracts and other non-protein materials, and added preservatives and stabilizers. (Identical to predicate). |
| Matrix is substantially equivalent to predicate (human serum). | The modified device uses a liquid stable control material prepared from human serum. (Identical to predicate). |
| Storage Condition is substantially equivalent to predicate (-20°C). | The modified device storage condition is -20°C. (Identical to predicate). |
| Analyte list is substantially equivalent to predicate (minor modifications, but no new claims). | The modified device includes a very similar list of analytes to the predicate. New analytes are added, but "no claims are made" regarding them, implying they are not core to the equivalence claim for existing assays. Some analytes marked with * in the predicate device list are indicated as "not added, as found in the source material" for the modified device, implying their removal or non-addition does not affect the substantial equivalence of the core function. |
2. Sample size used for the test set and the data provenance
Not applicable/provided. This device is a quality control material, not an AI/ML diagnostic tool requiring a test set of patient data. The "testing" involved demonstrating its characteristics and comparing them to a predicate.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/provided. "Ground truth" in the context of AI/ML diagnostics is not relevant here. The "truth" for this device lies in its chemical composition and its ability to act as a stable control with known concentrations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/provided. No adjudication method for a "test set" is relevant for this device.
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 not an AI/ML device and no MRMC study was conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "truth" for this quality control material is its specified chemical composition and stability, which would be established through analytical chemistry and stability studies, not medical expert consensus or pathology on patient data.
8. The sample size for the training set
Not applicable/provided. This is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable/provided. This is not an AI/ML 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.