(30 days)
The IMMULITE® 2000 LH Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE LH assay on the IMMULITE 2000 systems.
The IMMULITE® 2000 Free T3 Calbration Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Free T3 assay on the IMMULITE 2000 systems
The IMMULITE® 2000 Gastrin Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Gastrin assay on the IMMULITE 2000 systems
The IMMULITE 2000 LH Calibration Verification Material (CVM) contains one set of four vials each 3.0mL after reconstitution. CVM1 contains lyophilized bovine serum with preservatives. CVM2, CVM3 and CVM4 contain various levels of LH antigen from human pituitary glands in a lyophilized bovine serum matrix with preservatives.
IMMULITE® 2000 Free T3 Calibration Verification Material (CVM) contains one set of four vials. CVM1 contains 4.0 mL processed lyophilized human serum with preservatives after reconstitution. CVM2, CVM3 and CVM4 contain 2.0mL/vial of various levels of 3,31 Triiodo-L-Thyronine (Free Acid) in processed lyophilized human serum with preservatives after reconstitution.
The IMMULITE 2000 Gastrin Calibration Verification Material (CVM) contains one set of four vials, 2.0 mL each after reconstitution. CVM1 contains a lyophilized processed buffered human protein matrix with preservatives. CVM2, CVM3 and CVM4 contain various levels of synthetic-human gastrin in a lyophilized processed buffered human protein matrix with preservatives.
This document describes the acceptance criteria and performance testing for three In Vitro Diagnostic (IVD) calibration verification materials: IMMULITE® 2000 LH CVM, IMMULITE® 2000 Free T3 CVM, and IMMULITE® 2000 Gastrin CVM. The study proving the devices meet acceptance criteria is the Stability Study.
Due to the nature of these devices (Quality Control Materials), the typical AI/human comparative effectiveness studies, expert consensus for ground truth, or distinct training/test sets are not applicable as they are for diagnostic algorithms. Instead, the performance is evaluated by ensuring the material's dose values remain within specified acceptable ranges over time and under various conditions, determined by the instrument's calibrated reference curve.
The following information focuses on the LH CVM, Free T3 CVM, and Gastrin CVM separately, as each has its own specific acceptance criteria and performance data.
IMMULITE® 2000 LH Calibration Verification Material (CVM)
1. Table of Acceptance Criteria and Reported Device Performance
The stability study was conducted to validate real-time shelf life and open component (in-use or open vial) claim.
| CVM level | Assigned Dose (mIU/mL) | Guideline Criteria % difference to assigned dose | Acceptable dose range (mIU/mL) | Reported Performance (Implied by meeting criteria) |
|---|---|---|---|---|
| LLHCVM1 | 0.00 | Not Applicable | ≤ 0.1 | Likely met ≤ 0.1 mIU/mL |
| LLHCVM2 | 1.28 | ±18% | 1.05 - 1.51 | Likely fell within 1.05 - 1.51 mIU/mL |
| LLHCVM3 | 47.2 | ±12% | 41.5 – 52.9 | Likely fell within 41.5 – 52.9 mIU/mL |
| LLHCVM4 | 190 | ±14% | 163 – 217 | Likely fell within 163 – 217 mIU/mL |
Note: The document states the tests were performed to demonstrate the device meets performance specifications, and concludes substantial equivalence, implying the acceptance criteria were met. Specific numerical results for each time point are not provided in this summary.
2. Sample size used for the test set and the data provenance:
- Real-time shelf life stability: Not explicitly stated as a "test set" in the traditional sense, but the stability CVMs and reference CVMs were run in duplicate (as a minimum) at time points: 0, 72, 84, and 109 months.
- Open Component testing: LH CVM lot 090 was tested at 2-hourly intervals for up to 9 hours.
- Data Provenance: Not explicitly stated, but implied to be from internal laboratory testing at Siemens Healthcare Diagnostics Inc. (Tarrytown, NY, USA). This is a prospective test to determine the stability of newly manufactured CVMs.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable in the context of IVD calibration verification materials. Ground truth for dose values is established through traceability to international reference standards (WHO 1st IRP 68/40 and 2nd IS 80/552) and internal reference calibrators.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Results are compared against pre-defined numerical acceptance ranges.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a chemical reagent product used in an automated analyzer. Its performance is inherent to its chemical stability and manufacturing consistency in relation to the instrument's operation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth for the assigned dose values of the CVMs is established through traceability to WHO 1st IRP 68/40 and 2nd IS 80/552 via assigned reference calibrators. This falls under the category of reference standards.
8. The sample size for the training set:
Not applicable. This is a stability study for a calibration verification material, not a machine learning model.
9. How the ground truth for the training set was established:
Not applicable.
IMMULITE® 2000 Free T3 Calibration Verification Material (CVM) Summary
1. Table of Acceptance Criteria and Reported Device Performance
The stability study was conducted to validate shelf life claims.
| CVM level | Assigned Dose (pg/dL) | Guideline Criteria % difference to assigned dose | Acceptable dose range (pg/dL) | Reported Performance (Implied by meeting criteria) |
|---|---|---|---|---|
| LFT3CVM1 | 0.00 | N/A | ≤ 1.00 | Likely met ≤ 1.00 pg/dL |
| LFT3CVM2 | 1.48 | ±25% | 1.11 – 1.85 | Likely fell within 1.11 – 1.85 pg/dL |
| LFT3CVM3 | 7.30 | ±10% | 6.57 – 8.03 | Likely fell within 6.57 – 8.03 pg/dL |
| LFT3CVM4 | 44.5 | ±15% | 37.8 – 51.2 | Likely fell within 37.8 – 51.2 pg/dL |
Note: The document states the tests were performed to demonstrate the device meets performance specifications, and concludes substantial equivalence, implying the acceptance criteria were met. Specific numerical results for each time point are not provided in this summary.
2. Sample size used for the test set and the data provenance:
- Real-time shelf life stability: Stability CVMs and reference CVMs were run in duplicate (as a minimum) at time points: 0, 6, 12, and 18 months.
- Data Provenance: Not explicitly stated, but implied to be from internal laboratory testing at Siemens Healthcare Diagnostics Inc. (Tarrytown, NY, USA). This is a prospective test to determine the stability of newly manufactured CVMs.
3-6. Not applicable (same reasons as for LH CVM).
7. The type of ground truth used:
The ground truth for the assigned dose values of the CVMs is established through traceability to an internal material which has been gravimetrically prepared. This acts as a reference standard.
8-9. Not applicable.
IMMULITE® 2000 Gastrin Calibration Verification Material (CVM) Summary
1. Table of Acceptance Criteria and Reported Device Performance
The stability study was conducted to validate real-time shelf life and open component (in-use or open vial) claim.
| CVM level | Assigned Dose (pg/mL) | Guideline Criteria % difference to assigned dose | Acceptable dose range (pg/mL) | Reported Performance (Implied by meeting criteria) |
|---|---|---|---|---|
| LGACVM1 | 0.00 | N/A |
§ 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.