(47 days)
The IMMAGE Immunochemistry System Haptoglobin (HPT) reagent, in conjunction with Beckman Calibrator 1, is intended for use in the quantitative determination of human haptoglobin concentrations in human serum samples by rate nephelometry. This assay is designed for use with Beckman's IMMAGE Immunochemistry System.
The IMMAGE Immunochemistry System Haptoglobin (HPT) reagent, in conjunction with Beckman Calibrator 1, is intended for use in the quantitative determination of human haptoglobin concentrations in human serum samples.
Here's an analysis of the provided text, focusing on the acceptance criteria and study information for the IMMAGE™ Immunochemistry System Haptoglobin (HPT) Reagent.
Please note: The provided document is a 510(k) summary, which often focuses on demonstrating substantial equivalence to a predicate device rather than presenting de novo acceptance criteria for a novel device. As such, some information (like standalone performance targets without a comparative predicate, or extensive details on ground truth setting for complex clinical scenarios) might be less explicit or not present, as the primary goal is to show the new device performs similarly to an already-approved device.
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implicit from Predicate, or Explicit) | Reported Device Performance (IMMAGE HPT Reagent) |
|---|---|---|
| Method Comparison | Substantial equivalence to predicate device (Beckman's HPT Haptoglobin Reagent on Array® Systems). | Slope: 1.004, Intercept: -6.80, r: 0.996 |
| Stability - Shelf-life | Same as predicate (24 months at 2-8°C) | 24 months |
| Stability - Open Container | Not explicitly stated as a criterion, but a claim is made. | 14 day open container stability |
| Stability - Calibration | Not explicitly stated as a criterion, but a claim is made. | 14 day calibration stability |
| Imprecision (Within-Run) | Not explicitly stated numerically as an acceptance criterion. Implicitly, performance should be acceptable for clinical use and comparable to predicate. | Level 1 (60.8 mg/dL): %CV = 1.4 |
| Level 2 (136 mg/dL): %CV = 2.5 | ||
| Level 3 (322 mg/dL): %CV = 2.8 |
Explanation of Implicit Criteria:
For 510(k) submissions, the acceptance criteria are largely implicit in demonstrating "substantial equivalence" to a predicate device. This means the new device needs to perform as well as, or virtually identically to, the predicate device in relevant performance characteristics. The strong correlation (r = 0.996) and slope/intercept close to 1 and 0 respectively for method comparison are key indicators of this equivalence. Similarly, the stability and imprecision data are presented without explicit numerical targets but are intended to show acceptable performance for an in vitro diagnostic.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- Method Comparison: Not explicitly stated, but the summary refers to "method comparison" studies. The number of samples (e.g., patient samples) used to generate the slope, intercept, and 'r' value is not provided.
- Imprecision:
- For each of the three control levels, 80 results were used to calculate the mean, SD, and %CV.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). This type of detail is often omitted in a 510(k) summary for in vitro diagnostic devices unless there are specific clinical or demographic implications. The samples are human serum, but their origin is not described.
3. Number of Experts and Qualifications for Ground Truth
- Ground Truth Establishment: For an in vitro diagnostic (IVD) reagent like this, "ground truth" typically refers to the reference method (the predicate device in this case) or highly characterized control materials. It does not generally involve human expert interpretation in the same way as imaging or clinical decision support AI.
- Experts: Not applicable in the context of human expert review for establishing ground truth for a quantitative immunoassay.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. This document describes performance characteristics of a quantitative immunoassay, not a subjective diagnostic interpretation requiring adjudication among human readers.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not done. These studies are typically relevant for AI-powered diagnostic imaging or interpretation tools where human readers are involved in the diagnostic process. This device is a reagent for a quantitative immunoassay system.
- Effect Size with AI Assistance: Not applicable, as no human readers or AI assistance in interpretation are described for this IVD.
6. Standalone Performance Study
- Standalone Performance: Yes, standalone performance was assessed for the IMMAGE HPT Reagent. The "Method Comparison Study Results" compare the IMMAGE HPT Reagent's measurements against the predicate device, effectively showing its performance in isolation (though compared to a reference). The "Estimated Within-Run Imprecision" also represents a standalone performance characteristic of the device.
- Method Comparison: The IMMAGE HPT results were directly correlated with the predicate.
- Imprecision: The device's internal variability was measured independently.
7. Type of Ground Truth Used
- Ground Truth Type:
- For Method Comparison: The "ground truth" was established by the predicate device (Beckman's HPT Haptoglobin Reagent on the Array® Systems). The IMMAGE HPT Reagent's values were compared to those obtained from the predicate.
- For Imprecision: The "ground truth" for the mean values was derived from control materials with established concentrations (Level 1, Level 2, Level 3).
8. Sample Size for the Training Set
- Training Set Sample Size: Not specified. For IVD reagents, the concept of a "training set" in the context of machine learning (where the term is most common) is generally not applicable. Reagent development involves extensive analytical validation (specificity, linearity, interference, matrix effects, etc.) rather than training an algorithm on a 'sample set'. The development process involves optimizing the chemical formulation and assay parameters based on performance against established analytical standards and reference methods.
9. How Ground Truth for the Training Set was Established
- Ground Truth for Training Set: Not applicable in the machine learning sense. The "ground truth" during the development and optimization of such a reagent would be based on:
- Chemical principles and established analytical methods for quantitative determination of haptoglobin.
- Reference materials and calibrators with certified or highly accurate haptoglobin concentrations.
- Performance characteristics required for clinical utility.
§ 866.5460 Haptoglobin immunological test system.
(a)
Identification. A haptoglobin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the haptoglobin (a protein that binds hemoglobin, the oxygen-carrying pigment in red blood cells) in serum. Measurement of haptoglobin may aid in the diagnosis of hemolytic diseases (diseases in which the red blood cells rupture and release hemoglobin) related to the formation of hemoglobin-haptoglobin complexes and certain kidney diseases.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.