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Elecsys PreciControl TS is used for quality control of the Elecsys TSH immunoassay on the Elecsys and cobas e immunoassay analyzers.

The Elecsys PreciControl TS is a lyophilized product consisting of human TSH at a euthyroid level in an equine serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels. All human material should be considered potentially infectious. All products derived from human blood are prepared exclusively from the blood of donors tested individually and shown to be free from HBsAg and antibodies to HCV and HIV. The testing methods applied were FDA-approved or cleared in compliance with the European Directive 98/79/EC, Annex II, List A.

This document describes the 510(k) submission for the Elecsys PreciControl TS, a quality control material for TSH immunoassays. The studies conducted focus on "Value Assignment," "Stability," and "Reconstitution" of the device.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance (Test Set)

• Value Assignment:
  • The controls are run in duplicate on at least three (3) MODULAR ANALYTICS E170 measuring cells.
  • The assigned value is the median of at least six (6) determinations per control level.
  • Data provenance: Not explicitly stated, but assumed to be internal laboratory testing by Roche Diagnostics. It would typically be prospective for a new product's value assignment.
• Stability Studies (Study 1 & 2):
  • "The on-test and reference materials were tested in duplicate."
  • "The PreciControl TS lot was evaluated in duplicate on the cobas e 411."
  • Sample size for "stressed" and "reference" is one lot, with duplicate measurements.
  • Data provenance: Internal laboratory testing by Roche Diagnostics, likely prospective for stability validation.
• Real-Time Stability Study (Study 3):
  • "Data for the time-points at 6, 12, 16, 19, 25 and 37 months tested in duplicate will be available."
  • "Currently, the shelf life claim is 24 months. This is based on real-time stability data of three lots."
  • Sample size: Three lots tested in duplicate at various time points.
  • Data provenance: Internal laboratory testing by Roche Diagnostics, prospective, ongoing.
• Reconstitution Time Study:
  • "PreciControl TS was reconstituted for 30 minutes (reference) and 60 minutes. Samples were evaluated in duplicate on the cobas e 411 analyzer."
  • Sample size: One lot used, with duplicate measurements at each time point.
  • Data provenance: Internal laboratory testing by Roche Diagnostics, likely prospective.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

This device is a quality control material for an immunoassay. The concept of "experts" and "ground truth" as typically applied to image-based diagnostic devices (e.g., radiologists interpreting images) is not directly applicable here.

• Value Assignment: The ground truth or "target value" for the TSH control material is established against the 2nd IRP WHO Reference Standard 80/558. This is a primary reference standard, not dependent on human expert interpretation.
• Stability and Reconstitution: Ground truth is against an unstressed reference material value or a value obtained under standard reconstitution conditions, measured by the same analytical equipment.

Therefore, no human experts are noted as establishing the ground truth for the performance studies of this quality control device.

4. Adjudication Method (Test Set)

Not applicable for this type of device and study. The measurements are quantitative and compared against established reference values or performance specifications, not subjective interpretations requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This device is a quality control material, not a diagnostic algorithm that assists human readers.

6. Standalone (Algorithm Only) Performance Study

This is a standalone performance study of the quality control material itself (Elecsys PreciControl TS) without human intervention in the result generation or interpretation by the device. The purpose is to characterize the performance of the control material (e.g., its target value, stability) when run on an automated immunoassay analyzer. The performance metrics are analytical (precision, recovery, stability), not diagnostic.

7. Type of Ground Truth Used

• Value Assignment: The ground truth for the analyte (TSH) concentration in the control material is traceable to the 2nd IRP WHO Reference Standard 80/558. This is a recognized international reference standard for TSH, providing a highly accurate and standardized basis for the assigned value.
• Stability and Reconstitution Studies: The ground truth for these studies is typically derived from reference measurements (e.g., freshly prepared material, material stored under optimal conditions, or material reconstituted according to the standard protocol). This involves comparing the "stressed" or "test" material's measurement against an unstressed or reference measurement using the same analytical method.

8. Sample Size for the Training Set

Not applicable. This is a quality control material, not an AI/ML algorithm that requires a "training set" in the conventional sense. The "value assignment" process and stability studies are for characterizing the product itself, not for training a model.

9. How the Ground Truth for the Training Set was Established

Not applicable, as no training set for an AI/ML algorithm is involved.

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Control for Thyroid Stimulating Hormone assays.

Horse serum albumin control with recombinant Thyroid Stimulating Hormone for use in TSH assays.

Here's an analysis of the provided text, focusing on the requested acceptance criteria and study information:

This submission (K962573 for the Elecsys® PreciControl TSH Assay) is a 510(k) Pre-market Notification for a quality control material, not a diagnostic device that performs measurements. Therefore, the "acceptance criteria" and "device performance" are related to its suitability as a control, such as its stability and ability to be assigned a value, rather than diagnostic accuracy metrics like sensitivity or specificity.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of a quality control material, the "acceptance criteria" relate to its manufacturing, stability, and value assignment, which are implicitly demonstrated through comparison to the predicate device and standardized methods. The document doesn't explicitly list "acceptance criteria" in the traditional sense of performance targets (e.g., minimum sensitivity). Instead, it describes the characteristics of the control material and confirms they are adequate for its intended use.

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a "test set" in the context of diagnostic performance. For a quality control material, testing would involve verifying its properties and stability. The specific sample sizes for these internal manufacturing and validation tests are not provided in the 510(k) summary. Given the date (1996), such detailed information for a control material was less frequently included in the public 510(k) summary than it might be today. There is no information on data provenance (country of origin, retrospective/prospective).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable. As this is a quality control material, there is no "ground truth" established by experts in the diagnostic sense (e.g., radiologists interpreting images). The "ground truth" for its value assignment comes from standardization against the WHO-reference material.

4. Adjudication Method for the Test Set

Not applicable. There is no diagnostic "test set" requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

Not applicable. This is not a diagnostic device, and therefore, no MRMC study involving human readers' performance with or without AI assistance would be relevant or conducted.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a quality control material, not an algorithm or a diagnostic device, so standalone performance in that context is not relevant.

7. The Type of Ground Truth Used

The "ground truth" for the Elecsys® PreciControl TSH is its assigned value, which is established by standardization against the World Health Organization (WHO) reference material #80/558. This is a recognized international standard for TSH assays.

8. The Sample Size for the Training Set

Not applicable. As a quality control material, there is no "training set" in the context of an algorithm or diagnostic model. Development would involve manufacturing and validation processes, but not machine learning training.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for a quality control material.

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