(86 days)
For quality control in the quantitative determination of substrates, electrolytes, lipids, enzymes, proteins, and drugs. The control is used for monitoring accuracy or precision for manual techniques and assays from Roche on automated clinical chemistry analyzers.
Roche Diagnostics Precinorm® Universal and Precipath® Universal Control Sera is a two level quality control product prepared from lyophilized human serum with addition of constituent analytes as required to obtain normal and pathological levels.
The provided 510(k) summary for "Precinorm® Universal and Precipath® Universal Control Sera" describes a quality control product for laboratory assays. However, it does not include detailed acceptance criteria or a specific study proving the device meets those criteria in the way typically expected for a diagnostic or AI-driven medical device.
Instead, the submission focuses on establishing substantial equivalence to an already marketed predicate device (K811832). This means the primary "study" presented is a comparison to demonstrate that the modified device performs similarly to the predicate, with the main modification being the inclusion of additional analytes.
Therefore, many of the requested points cannot be directly extracted from the provided text because they pertain to a different type of device evaluation (e.g., performance study for a diagnostic algorithm, clinical trial for a treatment).
Here's a breakdown based on the provided information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide a table of acceptance criteria with specific numerical targets. Instead, it relies on demonstrating equivalence to a predicate device. The performance is implied to be similar to the predicate device, which is an already marketed and cleared product.
| Characteristic | Predicate Device (K811832) | Modified Device (K992900) | Equivalence Claim |
|---|---|---|---|
| Intended Use | For control of chemistry assays. Well suited for manual and automated analytical procedures. | For quality control in the quantitative determination of substrates, electrolytes, lipids, enzymes, proteins, and drugs. Used for monitoring accuracy or precision for manual techniques and assays from Roche on automated clinical chemistry analyzers. | Substantially equivalent in purpose. |
| Format | Lyophilized pooled human serum with constituents added as required to obtain desired component levels. | Lyophilized pooled human sera with constituents added as required to obtain desired component levels. | Identical. |
| Levels | Two levels | Two levels | Identical. |
| Stability (Unreconstituted) | Stable at 2-8° C until expiration date | Stable at 2-8° C until expiration date | Identical. |
| Stability (Reconstituted, 2-8° C) | 2 days | 5 days | Improved. |
| Stability (Reconstituted, 25° C / 10-24° C) | 8 hrs (at 10-24° C) | 12 hrs (at 25° C) | Improved. |
| Stability (Reconstituted, -20° C) | 1 month, with exceptions | 1 month, with exceptions | Identical. |
| Analytes | Standard analytes (not explicitly listed in this excerpt but implied by original clearance) | Standard analytes + Additional analytes (Albumin, Gamma globulins, Copper, GLDH, Arylamidase, Lithium, Magnesium, Total iron binding capacity) | Modified device adds analytes. Performance for these new analytes is not detailed but assumed to be adequate for quality control as per the overall substantial equivalence claim. |
The "acceptance criteria" here are essentially "performs sufficiently well as a quality control material for the listed analytes on clinical chemistry analyzers, similar to the predicate device, and includes values for additional analytes." There are no specific performance metrics like sensitivity, specificity, or AUC as one might see for an AI diagnostic.
2. Sample Size Used for the Test Set and Data Provenance:
This information is not provided. The submission is a regulatory filing for a quality control product, not a performance study for a diagnostic. The "test set" would implicitly be the demonstration that the control material can be used to monitor accuracy and precision on various analyzers, but no specific data or sample sizes for this demonstration are detailed.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. For a quality control material, "ground truth" would be the known concentration of analytes within the control serum, established through validated reference methods and internal quality assurance processes by the manufacturer. This isn't a diagnostic device requiring expert interpretation of patient data.
4. Adjudication Method for the Test Set:
Not applicable for a quality control material.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No. This is a quality control product, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical control serum, not an algorithm.
7. The Type of Ground Truth Used:
For a quality control material, the "ground truth" for the assigned values of the analytes within the sera is established by the manufacturer through rigorous analytical testing using reference methods and internal standardization processes. This is implicit in the manufacturing of such products.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/machine learning device that requires a training set. The "training" for such a product involves its manufacturing process and validation of its stability and assigned values.
9. How the Ground Truth for the Training Set was Established:
Not applicable. This is not an AI/machine learning device. The "ground truth" for its inherent properties (analyte concentrations, stability) would be established through a manufacturer's internal quality control and validation procedures based on analytical chemistry principles.
§ 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.