(150 days)
The IMMAGE Immunochemistry System Alpha - Acid Glycoprotein (AAG) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 1, is intended for the quantitative determination of human alpha-acid glycoprotein by rate nephelometry.
The IMMAGE Immunochemistry System AAG Reagent in conjunction with Beckman Calibrator 1, is intended for use in the quantitative determination of alpha-acid glycoprotein concentrations respectively in human serum samples on Beckman's IMMAGE Immunochemistry System.
Here's a breakdown of the acceptance criteria and study information for the IMMAGE™ Immunochemistry System Alpha-Acid Glycoprotein (AAG) Reagent, based on the provided text:
Acceptance Criteria and Device Performance
The document doesn't explicitly state "acceptance criteria" with specific thresholds for method comparison metrics (Slope, Intercept, r-value). However, the "Summary of Performance Data" presents the results of these studies, implying these values are deemed acceptable for demonstrating substantial equivalence. The predicate device's performance would serve as the implicit benchmark.
Since explicit acceptance criteria are not provided for the method comparison, I will present the reported performance as fulfilling the implied acceptance for substantial equivalence based on the comparison to the predicate.
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Method Comparison | Strong correlation (r-value close to 1) with predicate device. | r = 0.994 |
| Slope close to 1. | Slope = 0.954 | |
| Intercept close to 0. | Intercept = 1.62 | |
| Stability | Meets specified shelf-life and open/calibration stability. | 24 month shelf-life, 14 day open container stability, 14 day calibration stability |
| Within-Run Imprecision | Not explicitly stated, but expected to be low. | Data not clearly provided in the excerpt. |
Note: The section for "Estimated Within-Run Imprecision" contains garbled text. Therefore, specific acceptance criteria and performance data for this metric cannot be extracted from the provided document.
Study Details
This submission describes the development of a reagent for use on an existing system (IMMAGE™ Immunochemistry System), not a standalone diagnostic device in the sense of an AI algorithm or imaging system. Therefore, some of the requested categories (like number of experts for ground truth, adjudication method, MRMC studies) are not applicable to this type of device and study.
1. Sample Sizes and Data Provenance:
- Test Set Sample Size (Method Comparison): 141 samples
- Data Provenance: Human serum samples. Country of origin not specified. The study appears to be prospective in nature, comparing the new reagent's performance against the existing predicate on new samples.
2. Number of Experts and Qualifications for Ground Truth:
- Not Applicable. This is a quantitative chemical assay. The "ground truth" for the method comparison is the measurement obtained from the established predicate device (Beckman AAG Reagent on Array® 360). There are no "experts" in the sense of clinical decision-makers involved in establishing ground truth for individual samples in this context.
3. Adjudication Method for Test Set:
- Not Applicable. As a quantitative assay comparison, there is no need for adjudication by experts. The comparison is between two quantitative measurements.
4. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
- No. This type of study is not applicable to a chemical assay reagent. MRMC studies are typically used for diagnostic imaging or other subjective interpretation tasks where human readers are involved.
5. Standalone Performance Study:
- Yes, in essence. The "Method Comparison Study Results" section directly shows the performance of the IMMAGE AAG Reagent (the "algorithm/device" in this context) in generating quantitative results compared to an established method. This demonstrates the reagent's performance on its own, albeit in comparison to a predicate, not necessarily against a "true" gold standard across all possible ranges.
6. Type of Ground Truth Used:
- Comparison to a Predicate Method. The "ground truth" for the method comparison study was the quantitative results obtained from the Beckman AAG Reagent on Array® 360, which is the well-established predicate device. This is a form of comparative truth rather than an absolute biological truth like pathology or outcomes data.
7. Sample Size for Training Set:
- Not specified. The document does not mention a "training set" in the context of an algorithm. This is a chemical reagent, likely optimized through laboratory development and testing rather than machine learning training.
8. How Ground Truth for Training Set was Established:
- Not Applicable. As there's no specified "training set" in the machine learning sense, this question is not relevant. The reagent development would have involved various analytical chemistry and formulation studies, but not "ground truth" establishment for training an algorithm.
§ 866.5420
Alpha -1-glycoproteins immunological test system.(a)
Identification. Analpha- 1-glycoproteins immunological test system is a device that consists of the reagents used to measure by immunochemical techniquesalpha- 1-glycoproteins (a group of plasma proteins found in thealpha- 1 group when subjected to electrophoresis) in serum and other body fluids. Measurement of specificalpha- 1-glycoproteins may aid in the diagnosis of collagen (connective tissue) disorders, tuberculosis, infections, extensive malignancy, and diabetes.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.