K Number
K143636
Date Cleared
2015-02-25

(65 days)

Product Code
Regulation Number
862.1660
Panel
CH
Reference & Predicate Devices
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

IMMULITE® 2000 Androstenedione Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Androstenedione assay on the IMMULITE 2000 systems
IMMULITE® 2000 Troponin I Calibration Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Troponin I assay on the IMMULITE 2000 systems

Device Description

The IMMULITE® 2000 Androstenedione Calibration Verification Material (CVM) contains one set of four vials each 2mL in liquid form. CVM1 contains processed human serum with preservatives. CVM2, CVM3 and CVM4 contain androstenedione in processed human serum matrix with preservative.
The IMMULITE® 2000 Troponin I Calibration Verification Material (CVM) contains one set of four vials, 2mL each after reconstitution. CVM1 contains equine serum with 0.88% sodium azide and preservative. CVM2, CVM3 and CVM4 contain human Troponin I and rabbit Troponin C in equine serum matrix with 0.88% sodium azide and preservative.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the studies for both the IMMULITE® 2000 Androstenedione Calibration Verification Material and the IMMULITE® 2000 Troponin I Calibration Verification Material, based on the provided document:


Device 1: IMMULITE® 2000 Androstenedione Calibration Verification Material (CVM) (K143636)

1. Table of Acceptance Criteria and Reported Device Performance

The provided document details the stability acceptance criteria. Performance data is presented within the context of demonstrating compliance with these stability criteria rather than as a separate "reported performance" table.

CVM LevelDose at Time 0 (ng/mL)Guideline Criteria % difference to time 0Acceptable Dose Range (ng/mL)Reported Performance (from stability study, implicitly deemed compliant)
LAOCVM10.00N/A≤ 0.3For LAOCVM1, the dose at time 0 is 0.00 ng/mL, and the acceptable range is ≤ 0.3 ng/mL. The study implicitly found values within this range over the stability period, as it states the device "meets the performance Specifications for its intend use." However, specific numerical results for each time point are not provided in this summary.
LAOCVM21.93±10%1.74 - 2.12For LAOCVM2, the dose at time 0 is 1.93 ng/mL. The acceptable range is 1.74 - 2.12 ng/mL. The stability study results are described as supporting the claimed stability, indicating results fell within this range.
LAOCVM36.68±10%6.01 - 7.35For LAOCVM3, the dose at time 0 is 6.68 ng/mL. The acceptable range is 6.01 - 7.35 ng/mL. The stability study results are described as supporting the claimed stability, indicating results fell within this range.
LAOCVM415.4±13%13.4 - 17.4For LAOCVM4, the dose at time 0 is 15.4 ng/mL. The acceptable range is 13.4 - 17.4 ng/mL. The stability study results are described as supporting the claimed stability, indicating results fell within this range.

2. Sample Size for Test Set and Data Provenance

  • Test Set Description: The "test set" in this context refers to the samples used in the stability studies and value assignment.
    • Stability Studies: Multiple samples of each CVM level (LAOCVM1, LAOCVM2, LAOCVM3, LAOCVM4) from lot 006 were tested.
    • Real-time Stability: Samples were tested in duplicate at Day 0, 15, 27, and 38 months (Table 2). The specific number of individual vials/runs for each time point beyond "duplicate (as a minimum)" isn't detailed.
    • Open Component Stability: CVM lot 006 was tested at 2-hourly intervals for up to 9 hours. The number of samples per interval is not explicitly stated beyond "in duplicate (as a minimum)".
    • Value Assignment Validation: 28 samples (10 normal female serum samples and 18 spiked samples) and four levels of commercially available controls were used.
    • Expected Values/Target Values/Reference Range: Each CVM level was tested for a total of 27 replicates (9 runs and 3 replicates per run) using 3 different reagent kit lots and 8 IMMULITE 2000 systems.
  • Data Provenance: Not explicitly stated as "country of origin," but "internal material" and "gravimetrically prepared" suggest internal laboratory data. It is prospective testing designed to characterize the device's performance.

3. Number of Experts and Qualifications for Ground Truth

  • Not Applicable. This device is an in vitro diagnostic reagent (calibration verification material) for laboratory instruments, not an AI or imaging device requiring expert interpretation for ground truth. Ground truth is established through metrological traceability and standard reference methods (gravimetric preparation, assigned reference calibrators).

4. Adjudication Method for Test Set

  • Not Applicable. See point 3.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

  • Not Applicable. See point 3.

6. Standalone Performance (Algorithm Only)

  • Yes, in essence. The performance testing described (stability, value assignment) evaluates the intrinsic performance of the CVM as a standalone device (material), independent of human interpretation. Its function is to verify instrument calibration, not to provide diagnostic interpretations.

7. Type of Ground Truth Used

  • Metrological Traceability: The CVMs are traceable to an internal material that has been gravimetrically prepared. They are also value assigned using assigned reference calibrators, which themselves would have established traceability.
  • Reference Calibrators: The CVMs are described as a subset of 7-level Androstenedione calibrators, and their dose values are generated using curves from these assigned reference calibrators. These calibrators serve as the "ground truth" reference for verifying the CVM values.

8. Sample Size for Training Set

  • Not Applicable in the conventional sense of machine learning. This is not an AI/ML device. The "training" here refers to the process of establishing the reference values and behavior of the CVM and the associated assay. The value assignment process describes the materials and procedures used to characterize the CVMs, which inherently involves multiple measurements and statistical analysis rather than a distinct "training set" like in AI.

9. How Ground Truth for Training Set Was Established

  • Not Applicable in the AI sense. For this device, "ground truth" (or more appropriately, reference values) for the CVMs are established through:
    • Gravimetric Preparation: The internal material to which the CVMs are traceable is gravimetrically prepared, a fundamental method for establishing concentration.
    • Assigned Reference Calibrators: The CVMs' dose values are derived from curves generated by assigned reference calibrators. These reference calibrators represent the established "ground truth" for the assay.
    • Validated Materials and Procedures: The CVMs are manufactured using qualified materials and measurement procedures, ensuring their accuracy relative to the established reference values.

Device 2: IMMULITE® 2000 Troponin I Calibration Verification Material (CVM) (K143636)

1. Table of Acceptance Criteria and Reported Device Performance

Similar to the Androstenedione CVM, the document specifies stability acceptance criteria and indicates successful performance without providing detailed numerical results for each time point beyond the initial dose.

CVM LevelDose at Time 0 (ng/mL)Guideline Criteria % difference to Time 0Acceptable Dose Range (ng/mL)Reported Performance (from stability study, implicitly deemed compliant)
LTICVM10.00N/A≤0.20For LTICVM1, the dose at time 0 is 0.00 ng/mL, and the acceptable range is ≤ 0.20 ng/mL. The stability study supports the claimed stability, indicating results fell within this range.
LTICVM20.56±10%0.50 - 0.62For LTICVM2, the dose at time 0 is 0.56 ng/mL. The acceptable range is 0.50 - 0.62 ng/mL. The stability study supports the claimed stability, indicating results fell within this range.
LTICVM313.8±10%12.4 - 15.2For LTICVM3, the dose at time 0 is 13.8 ng/mL. The acceptable range is 12.4 - 15.2 ng/mL. The stability study supports the claimed stability, indicating results fell within this range.
LTICVM4159±10%143 - 175For LTICVM4, the dose at time 0 is 159 ng/mL. The acceptable range is 143 - 175 ng/mL. The stability study supports the claimed stability, indicating results fell within this range.

2. Sample Size for Test Set and Data Provenance

  • Test Set Description:
    • Stability Studies: Multiple samples of each CVM level (LTICVM1, LTICVM2, LTICVM3, LTICVM4) from lot 010 were tested.
    • Real-time Stability: Samples were run in duplicate (as a minimum) at Day 0, 3, 9, and 10 months (Table 2). Specific counts beyond "duplicate" are not specified.
    • Open Component Stability: CVM lot 090 was tested at 2-hourly intervals for up to 9 hours. Specific counts not detailed.
    • Value Assignment Validation: Three levels of commercially available controls and 25 spiked samples were used.
    • Expected Values/Target Values/Reference Range: Tested on 15 replicates in total (5 runs and 3 replicates per run) using 4 IMMULITE 2000 systems and 2 different reagent kit lots.
  • Data Provenance: Not explicitly stated as "country of origin," but "internal standard" and "gravimetrically prepared" suggest internal laboratory data. It is prospective testing.

3. Number of Experts and Qualifications for Ground Truth

  • Not Applicable. See point 3 for Androstenedione CVM.

4. Adjudication Method for Test Set

  • Not Applicable. See point 3 for Androstenedione CVM.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

  • Not Applicable. See point 3 for Androstenedione CVM.

6. Standalone Performance (Algorithm Only)

  • Yes, in essence. Similar to the Androstenedione CVM, the performance testing described evaluates the intrinsic performance of the Troponin I CVM as a standalone material.

7. Type of Ground Truth Used

  • Metrological Traceability: The CVMs are traceable to an internal standard that has been gravimetrically prepared.
  • Reference Calibrators: The CVMs are described as a subset of 10-level Troponin I calibrators, and their dose values are generated using curves from these assigned reference calibrators, which serve as the "ground truth" reference.

8. Sample Size for Training Set

  • Not Applicable in the conventional sense of machine learning. See point 8 for Androstenedione CVM.

9. How Ground Truth for Training Set Was Established

  • Not Applicable in the AI sense. For this device, "ground truth" (reference values) are established through:
    • Gravimetric Preparation: The internal standard to which the CVMs are traceable is gravimetrically prepared.
    • Assigned Reference Calibrators: The CVMs' dose values are derived from curves generated by assigned reference calibrators, which represent the established "ground truth" for the assay.
    • Validated Materials and Procedures: The CVMs are manufactured using qualified materials and measurement procedures, ensuring their accuracy relative to the established reference values.

§ 862.1660 Quality control material (assayed and unassayed).

(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.