(17 days)
Precinorm ® U/ Precipath ® U is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet.
Precinorm ® U/ Precipath ® U is a two level quality control product consisting of lyophilized human sera with constituents added as required to obtain desired component levels
This document is a 510(k) summary for the Precinorm® Universal and Precipath® Universal Control Sera. It is a submission for a multi-analyte control product used for quality control in quantitative laboratory methods. The submission declares substantial equivalence to a previously marketed device (K992900).
Here's the breakdown of the information requested, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
It's important to note that this 510(k) submission is for a quality control product, not a diagnostic device with specific performance metrics like sensitivity or specificity. The "acceptance criteria" here relate to demonstrating substantial equivalence to a predicate device, primarily by showing that the modified device's characteristics (intended use, format, levels, stability) are the same, and the change in analyte source does not compromise performance.
| Characteristic | Acceptance Criteria (Implied by Substantial Equivalence to Predicate K992900) | Reported Device Performance (Modified Device) |
|---|---|---|
| Intended Use | For use in quality control by monitoring accuracy and precision for quantitative methods as specified in the value sheet. | Same (meets criterion) |
| Format | Lyophilized human sera with constituents added as required. | Same (meets criterion) |
| Analyte source for albumin and total protein methods in Precinorm U | Human serum. | Human serum and bovine plasma albumin (Difference noted, but deemed unsubstantial). |
| Analyte source for albumin and total protein methods in Precipath U | Human serum. | Same (meets criterion) |
| Levels | Two levels. | Same (meets criterion) |
| Stability (Lyophilized) | Stable at 2-8°C until expiration date. | Same (meets criterion) |
| Stability (Reconstituted 2-8°C) | 5 days. | Same (meets criterion) |
| Stability (Reconstituted 15-25°C) | 12 hours. | Same (meets criterion) |
| Stability (Reconstituted -15 to -25°C) | 1 month (when frozen once). | Same (meets criterion) |
| Exceptions for total and direct bilirubin | As noted in package insert. | Same (meets criterion) |
Study Proving Acceptance Criteria:
The document describes a submission seeking substantial equivalence to a predicate device (K992900). The "study" here is essentially a comparison study demonstrating that the characteristics of the modified device Precinorm U/ Precipath U are either identical to the predicate or that any differences (specifically the addition of bovine plasma albumin as an analyte source for Precinorm U) do not alter the fundamental safety or effectiveness of the device as a quality control material. The basis for substantial equivalence is listed as the currently marketed Roche Diagnostics Precinorm® Universal and Precipath® Universal Control Sera (K992900).
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the given text. For a quality control product, a "test set" in the traditional sense of patient samples for diagnostic performance is not applicable. The comparison likely involved testing the modified control material against the predicate material over a range of analytes and instruments to ensure equivalent performance, but no details on sample size, data origin, or study design are given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided and is generally not applicable for a quality control product submission. The "ground truth" for a control material would be its assigned target values and acceptable ranges, typically established through extensive reference methods and laboratory consensus across multiple instruments and laboratories, not by a small number of experts interpreting results.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided and is not applicable for this type of submission. Adjudication methods are used in studies involving human interpretation or clinical outcomes, not typically for the characterization of a quality control product.
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
A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned and is not relevant for this device. This type of study is specific to diagnostic imaging devices, often involving AI, where human readers interpret medical images. This submission is for a laboratory quality control material.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable for this device. This device is a biochemical control material, not a software algorithm or a device that performs a diagnostic task independently. Its "performance" is its ability to consistently produce target values and reflect the accuracy and precision of the analytical systems it is used to control.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for a quality control product like Precinorm U/ Precipath U is typically established by:
- Assigned Target Values: These are derived from extensive testing using recognized reference methods and inter-laboratory studies across a range of instruments.
- Acceptable Ranges: Determined statistically from these studies to encompass expected variation for different analytical platforms.
The document does not explicitly state how the target values and ranges for these specific control sera were established, but this is the general method for such products. It certainly isn't expert consensus on clinical findings, pathology, or outcomes data, as this product is not a diagnostic test for patient samples.
8. The sample size for the training set
This is not specified and is not directly applicable in the terms of a "training set" for a machine learning algorithm. For a quality control material, the equivalent would be the number of lots, replicates, and instruments used in the characterization studies to set target values and stability claims. This detail is not provided.
9. How the ground truth for the training set was established
As in point 7 and 8, the concept of a "training set" and its "ground truth" is not directly relevant to this non-AI, non-diagnostic quality control product. The "ground truth" (i.e., the expected performance characteristics of the control material over its shelf-life) would be established through rigorous analytical testing and characterization studies, often involving multiple laboratories and instruments, to assign values and validate stability under various conditions. The document does not provide details on these specific studies, beyond stating the product's stability claims.
§ 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.