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Immunoturbidometric assay for the quantitative in-vitro determination of Haptoglobin.

Immunological latex agglutination test for the in vitro quantitative determination of haptoglobin in human scrum and plasma.

Mcasurement of haptoglobin may aid in the diagnosis of hemolytic discases in which the red blood cells rupture and release hemoglobin) related to the formation of hemoglobinhaptoglohin complexes and ccrtain kidncy discascs.

The Haptoglobin determination is based upon turbidimetric immunoinhibition (TINIA) using a serum or plasma blood sample. The sample containing Haptoglobin is transferred into a TRIS buffer solution (R₁ reagent). In the second step, an aliquot of solution of polyclonal anti-human Haptoglobin antibodies (R₂ reagent) is added to mixture of the first step. The antibody will bind to the Haptoglobin in the sample to form “aggregates” such that the amount of aggregate formed is proportionate to the amount of Haptoglobin present in the sample.

The resulting agglutination complex is measured turbidimetrically whereby increased turbidity is reflected through an increase in optical density. Therefore, the amount of Haptoglobin in the sample is directly proportional to the amount of turbidity formed.

The provided document describes the Tina-quant® Haptoglobin Assay, an immunoturbidimetric assay for the quantitative in-vitro determination of Haptoglobin. The document focuses on demonstrating substantial equivalence to a predicate device, the Behring BN® Haptoglobin assay, rather than presenting a standalone study with defined acceptance criteria and subsequent proof.

Therefore, much of the requested information cannot be directly extracted as it pertains to a typical new device validation study with specific acceptance criteria. However, I can provide the available information in the requested format, clearly indicating where data is not available or not applicable based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state "acceptance criteria" for the Tina-quant® Haptoglobin Assay in the way a new, independent validation study would. Instead, it presents performance characteristics and compares them to a predicate device to demonstrate substantial equivalence. The "acceptance criteria" are implied to be the comparable performance to the predicate device.

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

• Sample Size for Test Set:
  • Precision (Intra-Assay): N=21 for both Pool (low) and Pool (high). The document mentions "N=21" for the Tina-quant® Intra-Assay; for the Behring BN®, it states "N=30", implying 30 replicates.
  • Precision (Inter-Assay): N=21 for Sample 1, N/A for Sample 2 for Tina-quant®. The Behring BN® reports "N=10" for Sample 1 and 2. It's unclear if Sample 1 and Sample 2 for Tina-quant® represent independent samples or duplicates run over 21 days for example.
  • Method Comparison: N=98 for the comparison between Tina-quant® Haptoglobin and Behring BN® Haptoglobin.
• Data Provenance: Not explicitly stated. Given the manufacturer's location in the USA and the FDA submission, it's highly likely the studies were conducted in the USA, but no specific country of origin is mentioned. The studies appear to be prospective for the purpose of this submission (i.e., data was collected specifically to demonstrate device performance).

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

Not applicable. This is an in-vitro diagnostic assay that measures a specific analyte (Haptoglobin) quantitatively. The "ground truth" for such devices is typically established through reference methods or highly accurate comparative methods, not expert consensus. The comparison is made against existing commercial devices (Behring BN® Haptoglobin and Partigen® Haptoglobin).

4. Adjudication Method for the Test Set

Not applicable. As this is an in-vitro diagnostic assay measuring an analyte, there is no expert adjudication process in the traditional sense. The "adjudication" is essentially the statistical analysis comparing the new device's results to the predicate device's results.

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

No. This is an automated in-vitro diagnostic assay, not an imaging device or a diagnostic tool requiring human interpretation of cases. Therefore, an MRMC study is not relevant.

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

Yes, this is a standalone device. The performance characteristics (precision, linearity, method comparison, interfering substances, specificity) are reported for the Tina-quant® Haptoglobin Assay itself, without human-in-the-loop performance influencing the quantitative result. The device automates the measurement process.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the performance evaluation is established by:

• Comparison to a legally marketed predicate device: Behring BN® Haptoglobin assay.
• Comparison to another established method: Partigen® Haptoglobin (for linear regression).
• Internal validation metrics: Precision, linearity, interfering substances, and specificity are evaluated against internal standards or clinically accepted ranges/thresholds for these parameters.

8. The Sample Size for the Training Set

Not applicable. This document describes an in-vitro diagnostic assay, which is a chemical/biological reaction-based system, not a machine learning algorithm that requires a "training set" in the context of AI.

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

Not applicable, as there is no "training set" for this type of device.

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