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The IDS iSYS 25 VilD assay is intended for the quantitative determination of total 25-hydroxyvitamin D (125(OH)D) in hyman serum or plasma on the IDS iSYS Multi-Discipline Automated System. Results are to be used in conjunction with other clinical and laboratory data to assist the clinician in the assessment of vitamin D sufficiency in an adult population.

The IDS-iSYS 25 VitD Control Set is used for quality control of the IDS-iSYS 25 VitD assay on the IDS-iSYS Multi-Discipline Automated System.

The IDS-iSYS 25 VitDs reagent kit consists of one (1) Immunoassay Cartridge, one (1) vial each of 2 concentration Calibrator levels and a mini-CD containing the Instructions For Use (IFU), CRY files and Certificate of Analysis.

IDS-iSYS 25 VitDS Cartridge, sufficient for 100 tests, consists of reagents provided in individual compartment within a plastic container called the Cartridge. IDS-iSYS 25 VitDS Cartridge contains the following ready to use reagents:

• Magnetic particles coated with streptavidin in a phosphate . buffer containing sodium azide.
• . Sodium hydroxide solution.
• . 25(OH)D labelled with an acridinium ester derivative, in buffer containing bovine serum albumin with sodium azide.
• . Anti-25(OH)D sheep polyclonal antibody labelled with an biotin, in buffer containing bovine, sheep and mouse proteins and sodium azide.
• . Assay buffer containing proprietary displacing compounds, methanol and sodium azide.

The IDS-iSYS 25 VitD® Calibrators are included in the reagent kit. The ready to use calibrators contains human serum buffer matrix with two defined concentrations of 25(OH)D and sodium azide as preservative (

The provided document describes the IDS-iSYS 25VitD8 assay, a device for the quantitative determination of total 25-hydroxyvitamin D [25(OH)D] in human serum or plasma. Below is an analysis of its acceptance criteria and the studies performed.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" for all performance characteristics in a single, consolidated table. However, it presents performance data for various analytical characteristics, and in some cases, implicitly defines acceptable ranges or desired outcomes for these studies. For instance, in the specificity study, an acceptance criterion of "

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IDS-iSYS 17-OH Progesterone Control Set
The IDS-iSYS 17-OH Progesterone Control Set is for in vitro diagnostic use, for the quality control of the IDS-iSYS 17-OH Progesterone on the IDS-iSYS Multi-Discipline Automated System.
Rx Only.

IDS-iSYS 17-OH Progesterone Calibration Verifiers
The IDS-iSYS 17-OH Progesterone Calibration Verifiers are an in vitro diagnostic device intended for medical purposes in the quantitative verification of assay calibration and measuring range of the IDS-iSYS 17-OH Progesterone assay, when performed on the IDS-iSYS Multi Discipline Automated System.
Rx Only.

The IDS-iSYS 17-OH Progesterone Control Set consists of Two sets of three vials, 1.0 mL each in liquid form. Human serum containing 17-OH Progesterone and sodium azide as a preservative (

The provided text describes the acceptance criteria and supporting studies for two in vitro diagnostic devices: the IDS-iSYS 17-OH Progesterone Control Set and the IDS-iSYS 17-OH Progesterone Calibration Verifiers.

1. Table of acceptance criteria and the reported device performance:

• Precision: CV ≤ 10% for low concentration, ≤ 8% for middle and high concentration | - Accelerated stability studies (CLSI guideline EP25-A) support a stability claim of 9 months when stored at 2-8°C.
• Real-time studies are ongoing. (No explicit statement if current readings meet the mean concentration and precision criteria for the 9-month claim, only that it "supports" it). |
  | Open Vial Stability | Percent recoveries within 10% of the reference material concentration. | Data supports the open vial stability claim of 49 days when stored at 2-8°C. (Implies the 10% recovery criterion was met). |
  | On-Board Stability | Compared to a reference material run at time 0. (Specific quantitative criteria not explicitly stated, assumes comparison ensures acceptable performance.) | The on-board stability data supports the claimed on-board stability of 4 hours. (Implies acceptable comparison results). |
  | Calibration Verifiers | | |
  | Value Assignment | Assigned target value defined as the mean of all runs for the IDS-iSYS 17-OH Progesterone assay and analyzer. | Expected values: Cal Ver 0: Undetectable, Cal Ver 1: 2.0 ng/mL, Cal Ver 2: 8.0 ng/mL, Cal Ver 3: 17.0 ng/mL. (Similar to control set, implies these were achieved.) |
  | Closed Vial Stability | - Mean concentration must be within QC ranges (as stated in Certificate of Analysis)
• Precision: CV ≤ 10% for low concentration, ≤ 8% for middle and high concentration | - Accelerated stability studies (CLSI guideline EP25-A) support a stability claim of 9 months when stored at 2-8°C.
• Real-time studies are ongoing. (No explicit statement if current readings meet the mean concentration and precision criteria for the 9-month claim, only that it "supports" it). |
  | On-Board Stability | Compared to a reference material run at time 0. (Specific quantitative criteria not explicitly stated, assumes comparison ensures acceptable performance.) | The on-board stability data supports the claimed on-board stability of 4 hours. (Implies acceptable comparison results). |

2. Sample size used for the test set and the data provenance:

• IDS-iSYS 17-OH Progesterone Control Set - Value Assignment:
  • Sample Size: A minimum of 21 runs using cartridge batches (number of batches not specified) tested in triplicate on each of three IDS-iSYS Multi Discipline Automated Systems. Control solutions were prepared gravimetrically.
  • Data Provenance: Not explicitly stated as retrospective or prospective, nor country of origin. Given it's a device manufacturer's study to establish product characteristics, it's inherently prospective in nature.
• IDS-iSYS 17-OH Progesterone Control Set - Stability (All types):
  • Closed Vial (Real-time): Three lots of controls, tested in pentaplicate (5 replicates) at 2-month intervals for up to a minimum of 15 months. Each tested vial compared to reference material stored at -20°C.
  • Closed Vial (Accelerated): Performed according to CLSI guideline EP25-A.
  • Open Vial: Tested in duplicate at time points stated in the stability protocol (time points not detailed), against unopened vials.
  • On-Board: Three batches of controls, using three IDS-iSYS instruments. Tested at 0, 2, 4, 6, and 8 hours compared to a reference material at time 0.
  • Data Provenance: Same as above, likely prospective internal testing.
• IDS-iSYS 17-OH Progesterone Calibration Verifiers - Value Assignment:
  • Sample Size: Minimum of five runs for each cartridge batch (number of batches not specified) tested in triplicate on each of three IDS-iSYS Multi Discipline Automated Systems. Calibration Verifier solutions were prepared gravimetrically.
  • Data Provenance: Same as above, likely prospective internal testing.
• IDS-iSYS 17-OH Progesterone Calibration Verifiers - Stability (Closed Vial & On-Board):
  • Closed Vial (Real-time): Three lots of calibration verifiers, tested in pentaplicate (5 replicates) at 2-month intervals for up to a minimum of 15 months.
  • Closed Vial (Accelerated): Performed according to CLSI guideline EP25-A.
  • On-Board: Three batches of calibration verifiers, using three IDS-iSYS instruments. Tested at 0, 2, 4, 6, and 8 hours compared to a reference material at time 0.
  • Data Provenance: Same as above, likely prospective internal testing.

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):

This device is an in vitro diagnostic (IVD) quality control material and calibration verifier for automated systems, not an imaging AI device. The "ground truth" here refers to the reference values established for the control and calibration materials themselves, rather than diagnosis or interpretation by human experts.

• Value Assignment: The "ground truth" (assigned target values) for both the control set and calibration verifiers is established by the mean of all runs from multiple tests on three IDS-iSYS Multi Discipline Automated Systems, using cartridge batches, and confirmed by immunologic analysis using the IDS-iSYS 17-OH Progesterone assay. The solutions themselves are prepared gravimetrically from intermediate stock solutions.
• There are no "experts" in the traditional sense (e.g., radiologists) involved in establishing the ground truth for this type of chemical/immunological assay. The ground truth relies on the precision and accuracy of the analytical methods and the instrument itself.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. This is not a study involving human interpretation or subjective assessment of data that would require an adjudication method. The device's performance is determined by quantitative measurements and statistical analysis against predefined criteria.

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 device is an IVD quality control and calibration material, not an AI-powered diagnostic tool for human readers. No MRMC study was conducted or is relevant for this product.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Yes, the studies are inherently standalone as they evaluate the performance of the control and calibration materials on the IDS-iSYS Multi-Discipline Automated System. The system/assay performs the measurements without human intervention in the interpretation of the control/verifier results themselves beyond setting up the experiment and analyzing statistical compliance. The performance reported (e.g., mean concentration, CV, percent recovery) is that of the material as measured by the automated system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The ground truth used is based on:

• Gravimetric preparation: For the initial stock solutions and preparation of control/calibration verifier samples.
• Immunologic analysis: Confirmation of concentrations using the IDS-iSYS 17-OH Progesterone assay itself.
• Statistical averaging: The mean of multiple runs on multiple instruments to establish the assigned target values, treated as the reference ground truth for quality control and calibration verification.
• Reference material comparison: For stability studies, comparison to a reference control material stored under optimal conditions (-20°C).

This is a form of analytical ground truth derived from established quantitative laboratory methods and statistical analysis rather than clinical consensus or pathological diagnosis.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device that requires a training set. The values and stability characteristics are determined through direct analytical testing, not model training.

9. How the ground truth for the training set was established:

Not applicable. As there is no training set for an AI/machine learning model, no ground truth needed to be established for it.

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