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KENLOR H. pylori Serum Control is designed to provide unassayed precision control reagents. The controls are to be used with the in vitro immunoassay procedures for the qualitative determination of Helicobacter pylori IgG antibody in human serum assays. The controls are designed for routine use to provide a means of estimating precision and monitoring system performance. The controls are not intended to replace reagent controls furnished with the commercial kits. The control should be used like a patient sample to assist in the assessment of the listed analytical procedures.

The usefulness of Quality Control materials for monitoring the accuracy and precision of clinical testing is well documented.

Ready to use stabilized, Liquid Serum Control for qualitative determination of Helicobacter pylori IgG antibody in human serum assays. The controls contain 0.05% Sodium azide as preservative. The human source material is from human Serum and protein fractions of human serum.

This 510(k) summary describes a serum control device, not an AI or imaging device. Therefore, many of the requested categories (e.g., sample size for test/training sets, ground truth establishment for AI, MRMC studies, expert qualifications, adjudication methods) are not applicable to this type of medical device submission.

The primary acceptance criteria for this device revolve around its stability and ability to maintain its assigned values over time.

Here's a breakdown of the relevant information from the provided text, structured to address your request where applicable, and indicating "Not Applicable" where the information is inappropriate for a serum control.

Serology Control Device: Kenlor Liquid H. pylori IgG antibody Serum Control

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: "The mean of the assigned value is derived from assay of 24 vials that are representative of the lot." "The experimental values are the mean of three vials analyzed at the time period" for stability studies.
• Data Provenance: Not explicitly stated but implied to be from internal laboratory testing conducted by Kenlor Industries, Inc. (USA). The study is prospective in nature, as it involves monitoring controls over a defined period.

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

• Not Applicable. For a serum control, "ground truth" is established through laboratory assays and statistical methods to determine the assigned value and its expected range, rather than expert consensus on diagnostic images. The "ground truth" is the established concentration or reactivity of the analyte within the control.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods like 2+1 or 3+1 are used for diagnostic interpretation where there's subjectivity (e.g., image reading). For a serum control, performance is objectively measured against pre-defined statistical ranges.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

• No. MRMC studies are for evaluating the performance of diagnostic systems (often involving human readers and AI). This device is a control material, not a diagnostic system itself.

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

• Not Applicable. This is a physical serum control material, not an algorithm.

7. The type of ground truth used

• Expert Concensus: Not applicable in the traditional sense.
• Pathology: Not applicable.
• Outcomes Data: Not applicable.
• For this device, the "ground truth" is the statistically determined assigned value (mean) and its acceptable variations (2 x Standard Deviation) based on laboratory assays. This is established through internal testing using established analytical methods for H. pylori IgG antibody.

8. The sample size for the training set

• Not Applicable. This is not an AI or machine learning device requiring a training set. The "training" in this context refers to the initial characterization and assignment of values to the control lot.

9. How the ground truth for the training set was established

• Not Applicable in the AI sense. However, for a serum control, the assigned values (its "ground truth") are established by:
  • Assaying 24 representative vials from the lot to determine the mean assigned value.
  • Calculating the 2 x Standard Deviation (S.D.) of the assayed values to define the suggested target ranges.
  • This process ensures the control's established value is robust and reproducible.

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