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Pacific Hemostasis Heparin Control Plasma Level 2, an unassayed control plasma, is intended for use in heparin assay procedures. In addition, it can be used for quality control in monitoring heparin therapy with Activated Partial Thromboplastin Time (APTT) testing. It will yield APTT values in the moderately high abnormal range.

Pacific Hemostasis Heparin Control Level 2 is a lyophilized preparation of citrated plasma obtained from healthy donors, which contains sodium heparin, stabilizers and buffers. Each unit of source material used in the preparation of the reagent has been tested by an FDA approved method and found nonreactive for HBsAG and negative for antibodies to HIV and HCV.

The provided K992279 510(k) Summary describes the "Heparin Control Plasma, Level 2" device. This is an in vitro diagnostic device, specifically a control plasma used for heparin assay procedures and monitoring heparin therapy with Activated Partial Thromboplastin Time (APTT) testing.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

The summary does not explicitly state the specific "sample size" in terms of number of patient samples or test runs for the precision studies. It mentions "Between-run and within-run precision studies" were performed.

• Test Set Description: The test set for the precision study involved running both the Pacific Hemostasis Heparin Control Level 2 and the predicate device (Dade Ci-Trol Heparin Control High) to compare their precision.
• Data Provenance: The document does not specify the country of origin. Given the applicant's address in North Carolina, USA, it's highly probable the data was generated in the USA. The study appears to be prospective as it involves direct testing of the device performance.

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

This information is not applicable to this type of device and study. For in vitro diagnostic controls, the "ground truth" is often an established reference method or the expected performance characteristics based on the control's formulation and intended use, rather than expert consensus on a clinical diagnosis. The precision study assesses the device's consistency, not its diagnostic accuracy against a clinical "ground truth."

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in studies involving subjective interpretation of data (e.g., medical imaging) where multiple readers might disagree, and a consensus ground truth needs to be established. For objective measurements like APTT from a control plasma, such adjudication is not performed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., radiology AI). The Heparin Control Plasma is a laboratory reagent; its performance is measured objectively rather than by human readers' interpretations.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This concept is not applicable in the context of this device. The device itself is a control plasma, not an algorithm. Its "standalone performance" is its performance in a laboratory setting when analyzed by an APTT instrument. The precision studies are essentially evaluating the "standalone" performance of the control when used as intended.

7. The Type of Ground Truth Used

The "ground truth" for this precision study is the analytical precision itself, measured by statistical metrics like Coefficient of Variation (CV). There isn't a "ground truth" in the sense of a clinical outcome, pathology, or expert consensus that the device is trying to predict. Instead, the study aims to demonstrate that the device performs consistently and within acceptable analytical limits, similar to a legally marketed predicate device.

8. The Sample Size for the Training Set

There is no training set for this device. This device is a control plasma, not an AI/ML algorithm that requires training data.

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

As there is no training set, this question is not applicable.

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