(28 days)
ADVIA Chemistry Enzyme 1 Calibrator is intended for in vitro diagnostic use in the calibration of Gamma-Glutamyl Transferase (GGT), Lactate Dehydrogenase P-L (LDPL), Lactate Dehvdrogenase L-P (LDLP), Cholinesterase (CHE), and Lipase (LIP) assays on the ADVIA Chemistry systems.
ADVIA® Chemistry Enzyme 2 Calibrator is intended for in vitro diagnostic use in the calibration of Alanine Aminotransferase (ALT); Alanine Aminotransferase, Concentrated Reagents (ALT c); Alanine Aminotransferase (P5P) (ALTP5P); Alanine Aminotransferase (P5P), Concentrated Reagents (ALTP c); Aspartate Aminotransferase (AST); Aspartate Aminotransferase, Concentrated Reagents (AST_c); Aspartate Aminotransferase (PSP)(ASTP5P); and Aspartate Aminotransferase (P5P), Concentrated Reagents (ASTP_c) assays on the ADVIA Chemistry systems.
The ADVIA® Chemistry Enzyme 1 Calibrator and Enzyme 2 Calibrator are liquid, multianalyte, bovine serum albumin based products. Enzyme 1 Calibrator kit consists of six vials of the same calibrator which is ready for use (no preparation is required). The volume per vial is 2.5 mL. Enzyme 2 Calibrator kit consists of six vials of calibrator of the same level which is ready for use (no preparation is required). The volume per vial is 1.5 mL.
The provided document describes the Siemens ADVIA® Chemistry Enzyme 1 and Enzyme 2 Calibrators, which are intended for in vitro diagnostic use in the calibration of various enzyme assays. The document is a 510(k) summary, which aims to demonstrate substantial equivalence to previously cleared predicate devices.
Here's an analysis of the acceptance criteria and the study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document explicitly states: "Acceptance criteria is the mean concentration should be within ±15% of the target value." This acceptance criterion is applied during the verification of the commercial calibrator lot.
| Performance Metric | Acceptance Criteria (ADVIA Chemistry Enzyme 1 & 2 Calibrators) | Reported Device Performance |
|---|---|---|
| Commercial Calibrator Lot Verification | Mean concentration within ±15% of the target value | "the concentration of each analyte is verified to be within acceptable range by using an instrument calibrated with Master Lot Calibrators." (Implies acceptance criteria were met) |
| Stability (Shelf-life) | Not explicitly stated, but "acceptance criteria were met." | "minimum 6 months at 2-8°C at launch" (Enzyme 1 & 2 Calibrator) |
| Stability (Open-vial) | Not explicitly stated, but "acceptance criteria were met." | "30 days at 2-8°C" (Enzyme 1 & 2 Calibrator) |
2. Sample Size Used for the Test Set and Data Provenance
For the commercial calibrator lot value assignment:
- Sample Size: "Each instrument is calibrated using the Masterpool. The calibrators are run as unknowns with n=20 replicates." This indicates a sample size of 20 replicates for each analyte on each of the two instruments. The total number of calibrator vials used was three.
- Data Provenance: The data is prospective, generated during the manufacturing and verification process of the new calibrator lots. The country of origin is not explicitly stated but is implied to be where Siemens Healthcare Diagnostics Inc. (Tarrytown, NY) conducts its manufacturing and testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable in the context of calibrator performance. The "ground truth" for calibrators is their assigned target concentration based on reference materials and established methods, not clinical interpretation by experts.
4. Adjudication Method for the Test Set
This is not applicable as the "test set" involves quantitative measurements against target values, not subjective interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This type of study is for comparing human reader performance, typically in diagnostic imaging or similar fields. This document is about calibrator performance in a laboratory setting.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
Yes, in a sense. The core "performance" described is the ability of the calibrator lots to meet their target concentration specifications when measured on the ADVIA Chemistry systems, without direct human cognitive input influencing the measurement results. The setup involves instruments measuring the calibrators as "unknowns," which is a form of standalone performance measurement for the calibrator's assigned values.
7. Type of Ground Truth Used
The ground truth for the calibrator's value assignment is based on:
- Reference Materials: For several analytes (LDLP, GGT, ALT, AST), the ground truth is traceable to IFCC Reference materials or IFCC Reference methods.
- Molar Extinction Coefficient: For CHE and LDPL, the ground truth relies on the molar extinction coefficient of the reaction product or NADH, respectively.
- Internal Standard: For LIP, an internal standard is used.
- Master Lot Assigned Bottle Values: Initially, the stock solution concentration is determined by comparison to Master Lot assigned bottle values, which themselves would be traceable to the aforementioned reference standards/methods.
8. Sample Size for the Training Set
This product is a calibrator, not an algorithm that requires a "training set" in the machine learning sense. The concept of a training set is not applicable here.
9. How the Ground Truth for the Training Set Was Established
As explained above, there is no "training set" as this is not an AI/ML algorithm. The "ground truth" for the calibrators' assigned values is established through traceability to international reference materials, molar extinction coefficients, and internal standards, as detailed in point 7.
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(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 the limitations in § 862.9.