(15 days)
FOR IN VITRO DIAGNOSTIC USE. The SPQ TM Antibody Reagent Set for Lp(a) is designed for the quantitative determination of human lipoprotein(a) in mg/dL in human serum by immunoprecipitin analysis using a turbidimetric clinical analyzer. The measurement of Lp(a) is indicated for use in conjunction with clinical evaluation, patient risk assessment and other lipoprotein tests to evaluate disorders of lipid metabolism and to assess coronary heart disease (CHD) in male Caucasian populations.
Lipoprotein(a) Immunological Test Kit
The provided text describes a Special 510(k) for a device modification: Lp(a) SPQ™ III Antibody Reagent Set. The purpose of the submission is to demonstrate that the modified device, which includes an additional instrument application for the Hitachi 911 analyzer, is substantially equivalent to the predicate device.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in a table format. However, the overall acceptance criterion for this 510(k) submission is "Substantial Equivalence" to the predicate device. The performance is reported qualitatively.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Substantial Equivalence to the predicate device | "Bench testing with clinical samples demonstrated that the performance characteristics of the modified device were substantially equivalent to those of the predicate device." |
| Same technological basis as the predicate device | "The modified device has the same technological basis as the predicate device." |
| Labeling substantially equivalent to the predicate device | "The labeling of the modified device is substantially equivalent to that of the predicate device. Changes in the labeling and package insert directly reflect the device modification (the additional instrument application for the Hitachi 911)." |
| Quantitative determination of human lipoprotein(a) in mg/dL | Intended use is for "quantitative determination of human lipoprotein(a) in mg/dL" |
| Immunoprecipitin analysis using a turbidimetric clinical analyzer | Intended use specifies "immunoprecipitin analysis using a turbidimetric clinical analyzer." (The modification adds compatibility with Hitachi 911). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document states that "Bench testing with clinical samples" was performed. However, it does not specify the number of clinical samples used in this testing.
- Data Provenance: The document does not specify the country of origin of the data. Given the "FOR IN VITRO DIAGNOSTIC USE" and "human serum" description, it can be inferred that the data is from human subjects, likely in a clinical setting. It is a retrospective or prospective study is not explicitly stated, but "bench testing with clinical samples" suggests a study where samples were analyzed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not provide information on the number of experts used or their qualifications for establishing ground truth. For this type of in vitro diagnostic device, the ground truth would typically be established by a reference method or a clinically accepted laboratory standard, not by expert consensus in the traditional sense of image interpretation.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method for the test set. For an in vitro diagnostic assay, adjudication usually refers to resolving discrepancies in expert interpretations (e.g., in imaging studies). For a quantitative assay, the performance is typically compared against a reference method or established statistical measures.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or described. This type of study is typically relevant for interpretative devices (e.g., medical imaging AI) where human readers are involved. This device is an in vitro diagnostic (IVD) reagent set for quantitative measurement, which falls into a different category of performance assessment. The comparison is between the modified device and the predicate device's performance, not human readers with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device described is an in vitro diagnostic (IVD) reagent set, not an algorithm or AI. It is designed for "immunoprecipitin analysis using a turbidimetric clinical analyzer." Therefore, the concept of "standalone (algorithm only)" performance does not directly apply as it would for a software-based AI device. The performance evaluated is the measurement capability of the reagent set on an analyzer, which is inherently a "standalone" measurement in terms clinical context but not in the AI context.
7. The Type of Ground Truth Used
The type of ground truth used is implied to be quantitative measurements of human lipoprotein(a). For IVD devices, "ground truth" is typically established by:
- Comparison to a reference method (e.g., a more sensitive, specific, or established laboratory test).
- Correlation with clinically established standards or diagnostic criteria.
- In this case, the comparison is made against the predicate device's performance, implying the predicate device's results serve as a benchmark for substantial equivalence.
8. The Sample Size for the Training Set
The document does not mention a training set or any machine learning/AI components. This device is a chemical reagent set for a laboratory assay.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned (because the device is an IVD reagent set, not an AI/ML device), this question is not applicable.
§ 866.5600 Low-density lipoprotein immunological test system.
(a)
Identification. A low-density lipoprotein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the low-density lipoprotein in serum and other body fluids. Measurement of low-density lipoprotein in serum may aid in the diagnosis of disorders of lipid (fat) metabolism and help to identify young persons at risk from cardiovascular diseases.(b)
Classification. Class II (performance standards).