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The ST AIA-PACK hsE2 Calibrator Set is intended for In Vitro Diagnostic Use Only for the calibration of the ST AIA-PACK hsE2 assay.

• 2 x 1 mL ST AIA-PACK hsE2 Calibrator (1) 0 pg/mL Human serum containing no detectable concentration of estradiol with sodium azide as a preservative.
• 2 x 1 mL ST AIA-PACK hsE2 Calibrator (2) 25 pg/mL (approx.)
• ST AIA-PACK hsE2 Calibrator (3) 50 pg/mL (approx.)
• ST AIA-PACK hsE2 Calibrator (4) 100 pg/mL (approx.)
• ST AIA-PACK hsE2 Calibrator (5) 500 pg/mL (approx.)
• ST AIA-PACK hsE2 Calibrator (6) 1,100 pg/mL (approx.)
  Human serum containing the assigned concentration of estradiol (described on each vial) with sodium azide as a preservative.
  ST AIA-PACK hsE2 Calibrator Set P/N # 025325
  The ST AIA-PACK hsE2 Calibrator Set is designed specifically for use on the Tosoh AIA System Analyzers which have been previously cleared as a family of instruments under K971103. Only materials obtained from Tosoh should be used. Materials obtained elsewhere should not be substituted since assay performance is characterized based strictly on Tosoh materials.
  The ST AIA-PACK hsE2 Calibrator Set is designed for use with ST AIA-PACK hsE2 and ST AIA-PACK hsE2 Sample Diluting Solution.

The provided document describes the ST AIA-PACK hsE2 Calibrator Set and its performance.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document details two types of stability studies, each with its own acceptance criteria and results for recovery and reproducibility (CV%).

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The ST AIA-PACK PROG III Calibrator Set is intended for In Vitro Diagnostic Use Only for the calibration of the ST AIA-PACK PROG III assay.

• 2 x 1 mL ST AIA-PACK PROG III Calibrator (1) 0 nq/mL Bovine protein matrix containing no detectable concentration of progesterone with sodium azide as a preservative (Liquid).
• 2 x 1 mL ST AIA-PACK PROG III Calibrator (2) 0.5 ng/mL (approx.)
• ST AIA-PACK PROG III Calibrator (3) 1.5 ng/mL (approx.)
• ST AIA-PACK PROG III Calibrator (4) 5.0 ng/mL (approx.)
• ST AIA-PACK PROG III Calibrator (5) 15 ng/mL (approx.)
• ST AIA-PACK PROG III Calibrator (6) 45 ng/mL (approx.)
  Bovine protein matrix containing the assigned concentration of progesterone (described on each vial) with sodium azide as a preservative.
  The ST AIA-PACK PROG III Calibrator Set is designed specifically for use on the Tosoh AIA System Analyzers which have been previously cleared as a family of instruments under K971103. Only materials obtained from Tosoh should be used. Materials obtained elsewhere should not be substituted since assay performance is characterized based strictly on Tosoh materials.
  The ST AIA-PACK PROG III Calibrator Set is designed for use with ST AIA-PACK PROG III and ST AIA-PACK PROG III Sample Diluting Solution.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them, formatted as requested:

Acceptance Criteria and Device Performance Study for ST AIA-PACK PROG III Calibrator Set

This document describes the ST AIA-PACK PROG III Calibrator Set, a device intended for in vitro diagnostic use for the calibration of the ST AIA-PACK PROG III assay. The information provided heavily focuses on stability and value assignment studies to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size:
  • Real Time Stability: Not explicitly stated, but calibrator sets were assayed at 3, 6, and 9 months (implied multiple samples/replicates at each time point).
  • Open Vial Stability: Not explicitly stated, but samples were "reconstituted and stored... for 2 days and tested."
  • Value Assignment: 5 replicates of the test calibrator were analyzed for each calibrator level (Cal 2-6).
• Data Provenance: Not specified, but generally, such studies for regulatory submission are prospective and conducted in-house or by contract research organizations under the manufacturer's control. No country of origin is explicitly mentioned for the data itself, beyond the US location of the submitter.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• This device is a calibrator set for an in vitro diagnostic assay, not an AI or imaging device requiring human expert ground truth. The "ground truth" for calibrators is related to the reference materials and their assigned concentrations.
• For Value Assignment: The primary reference material was USP (United States Pharmacopeia) Standard (Lot #I1J239). The progesterone value of this reference material was assigned gravimetrically, which is a chemical/analytical method, not typically involving human expert consensus in the diagnostic sense.

4. Adjudication Method for the Test Set

• Not applicable. This is a calibrator set for an in vitro diagnostic device, and adjudication methods (like 2+1, 3+1 for medical image interpretation) are not relevant here. The evaluation relies on analytical performance criteria (recovery, CV%) against established reference values.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

• No. This is not an AI or imaging device; therefore, an MRMC study is not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

• The device itself is a calibrator, which is a reagent used by an instrument. Its performance is evaluated analytically, which is inherently "standalone" in the sense that its function (calibration) is determined by its chemical and physical properties and how it interacts with the instrument. There isn't an "algorithm only" performance metric in the typical sense of AI. The "algorithm" here is the assay procedure itself on the Tosoh AIA System Analyzers, and the calibrator's performance helps ensure the accuracy of that system.

7. The Type of Ground Truth Used

• Analytical/Reference Standard: The ground truth for the calibrator concentrations is established by referring to the USP (United States Pharmacopeia) Standard (Lot #I1J239). The values were assigned gravimetrically (for the primary reference material). This is a highly controlled chemical/analytical method, not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

• Not applicable. This is an in vitro diagnostic calibrator, not an AI model that requires a training set of data. The "training" in this context refers to the development and manufacturing of the calibrator itself, where the concentrations are established and verified against reference standards.

9. How the Ground Truth for the Training Set was Established

• Not applicable, as there is no "training set" in the AI sense for this type of device. The "ground truth" for the calibrator's assigned values is based on traceability to the USP (United States Pharmacopeia) Standard (Lot #I1J239), with primary reference material values assigned gravimetrically. These are highly standardized analytical procedures to ensure accuracy and consistency. The product calibrator values were then assigned using AIA-2000 instruments with the secondary reference material as calibrator.

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The ST AIA-PACK PROG II Calibrator Set is intended for In Vitro Diagnostic Use Only for the calibration of the ST AIA-PACK PROG II assay.

2 x 1 mL ST AIA-PACK PROG II Calibrator (1) 0 ng/mL Protein matrix containing no detectable concentration of PROG with sodium azide as a preservative (Liquid).
2 x 1 mL ST AIA-PACK PROG II Calibrator (2) 0.5 ng/mL (approx.)
ST AIA-PACK PROG II Calibrator (3) 1.5 ng/mL (approx.)
ST AIA-PACK PROG II Calibrator (4) 5.0 ng/mL (approx.)
ST AIA-PACK PROG II Calibrator (5) 15 ng/mL (approx.)
ST AIA-PACK PROG II Calibrator (6) 45 ng/mL (approx.)
Human serum containing the assigned concentration of progesterone (described on each vial) with sodium azide as a preservative.

The ST AIA-PACK PROG II Calibrator Set is designed specifically for use on the Tosoh AIA System Analyzers which have been previously cleared as a family of instruments under K971103. Only materials obtained from Tosoh should be used. Materials obtained elsewhere should not be substituted since assay performance is characterized based strictly on Tosoh materials.

The ST AIA-PACK PROG II Calibrator Set is designed for use with ST AIA-PACK PROG II and ST AIA-PACK PROG II Sample Diluting Solution.

Here's a breakdown of the acceptance criteria and study information for the ST AIA-PACK PROG II Calibrator Set, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size:
  • For stability studies (Real-Time and Open Vial): The exact number of individual samples tested isn't explicitly stated, but it mentions "AIA-PACK Progesterone Calibrator Set were stored..." and "Samples were reconstituted..." implying multiple sets or vials.
  • For value assignment: 5 replicates for each of the 5 calibrator levels (Cal 2-6) were analyzed.
• Data Provenance: The document does not specify the country of origin for the data. The data appears to be prospective as it involves the testing of the newly formulated ST AIA-PACK PROG II Calibrator Set under defined conditions (stability studies, value assignment protocol).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• The document does not mention the use of experts to establish the ground truth for the test set.
• The ground truth for the calibrators is established through a chain of traceability:
  • Primary reference material uses USP (United States Pharmacopeia) Standard as calibrator.
  • Secondary reference material is assigned against the primary reference material.
  • Product calibrators are assigned against the secondary reference material.
• The "experts" are the "Tosoh AIA-2000" instruments and the established calibration process rooted in the USP Standard.

4. Adjudication Method for the Test Set

• No human adjudication method (e.g., 2+1, 3+1) is mentioned or implied for the test set.
• The determination of acceptance is based on quantitative measurements against predefined criteria (recovery % and CV%).

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

• No, an MRMC comparative effectiveness study was not done.
• This device is a calibrator set for an in vitro diagnostic assay, not an AI-powered diagnostic tool that assists human readers. Therefore, this type of study is not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• This device is a calibrator set, not an algorithm. Therefore, "standalone algorithm performance" is not applicable in the context of AI.
• However, the performance of the calibrator itself is tested in a "standalone" fashion in that its stability and assigned values are determined within the analytical system (Tosoh AIA-2000 with the specified assay) without human interpretation being part of the performance measurement itself. The results are quantitative and objective based on instrument readings.

7. The Type of Ground Truth Used

• The ground truth for the calibrator values is established based on a reference standard and hierarchical assignment process:
  • The highest level of truth is the USP (United States Pharmacopeia) Standard for progesterone.
  • Subsequent calibrator lots and levels are then assigned values through a traceable process against this primary reference and internal secondary standards.

8. The Sample Size for the Training Set

• This document describes a calibrator set and its performance validation, not a machine learning or AI model. Therefore, there is no training set in the context of AI. The "training" for this device would be analogous to the manufacturing and value assignment process itself, ensuring each lot meets specifications.

9. How the Ground Truth for the Training Set Was Established

• N/A, as there is no training set in the AI context. The ground truth for the calibrator's assigned values is established through traceability to the USP Standard as described in point 7.

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The ST AIA-PACK C-Peptide II Calibrator Set is intended for In Vitro Diagnostic Use Only for the calibration of the ST AIA-PACK C-Peptide II assay.

2 x 1 mL ST AIA-PACK C-Peptide II Calibrator (1) 0 ng/mL Protein matrix containing no detectable concentration of C-peptide with sodium azide as a preservative (Liquid).
2 x 1 mL ST AIA-PACK C-Peptide II Calibrator (2) 0.5 ng/mL (approx.)
ST AIA-PACK C-Peptide II Calibrator (3) 2 ng/mL (approx.)
ST AIA-PACK C-Peptide II Calibrator (4) 6 ng/mL (approx.)
ST AIA-PACK C-Peptide II Calibrator (5) 15 ng/mL (approx.)
ST AIA-PACK C-Peptide II Calibrator (6) 33 ng/mL (approx.)
Protein matrix containing the assigned concentration of C-peptide (described on each vial) (Lyophilized).
The ST AIA-PACK C-Peptide II Calibrator Set is designed specifically for use on the Tosoh AIA Svstem Analyzers which have been previously cleared as a family of instruments under K971103. Only materials obtained from Tosoh should be used. Materials obtained elsewhere should not be substituted since assay performance is characterized based strictly on Tosoh materials.
The ST AIA-PACK C-Peptide II Calibrator Set is designed for use with ST AIA-PACK C-Peptide II, ST AIA-PACK C-Peptide Sample Diluting Solution, AIA-PACK C-Peptide Control Set.

Here's an analysis of the provided text regarding the ST AIA-PACK C-Peptide II Calibrator Set, focusing on acceptance criteria and supporting studies.

Based on the provided 510(k) Summary, this document primarily discusses the substantial equivalence of a calibrator set, not a diagnostic device with performance metrics like accuracy, sensitivity, or specificity in relation to a disease state. Therefore, many standard questions about AI device performance (like MRMC studies, standalone performance, training set details, expert qualifications for ground truth, etc.) are not applicable to this type of submission.

The "acceptance criteria" and "device performance" in this context refer to the stability and reproducibility of the calibrator set itself, not its diagnostic accuracy in patients.

1. Table of Acceptance Criteria and Reported Device Performance

This calibrator set's "performance" is assessed based on its stability and reproducibility rather than diagnostic accuracy.

The conclusions from these studies allowed the manufacturer to set:

• Shelf-life: 12 months at 2-8°C (based on 13-month data meeting criteria)
• In-use stability: 1 day (24 hours) after reconstitution at 2-8°C (based on 2-day data meeting criteria)

2. Sample Size Used for the Test Set and Data Provenance

• Test Set (Stability Studies) Sample Size:
  • Shelf-Life Stability: Three different lots of calibrator set. Each specimen (presumably from each lot at each time point) was assayed in 5 replicates. This refers to the number of lots tested, not patient samples.
  • In-Use Stability: One lot of calibrator material. Three sets of calibrator material were opened and reconstituted. Urine, serum, and EDTA plasma specimens were chosen for this study. Each specimen was assayed in 5 replicates. The number of patient specimens (urine, serum, EDTA plasma) is not explicitly stated, only that such specimens were chosen.
• Data Provenance: Not specified, but generally for such in-vitro diagnostic (IVD) calibrators, the studies are conducted internally by the manufacturer. The text does not mention country of origin or whether the studies were external. The nature of the study (stability of a reagent) suggests it's prospective testing in a lab setting.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Not applicable. This device is a calibrator set, not a diagnostic device requiring expert interpretation of results to establish a "ground truth" for clinical performance. Its "ground truth" (assigned C-peptide concentrations) is established through an analytical traceability chain to international standards (WHO 1ª IRP 84/510).

4. Adjudication Method for the Test Set

• Not applicable. There is no "adjudication" in the context of stability and reproducibility testing for a calibrator. The performance is assessed against predefined recovery and CV% criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. This is not an AI-powered diagnostic device, and thus MRMC studies are not relevant.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

• No. This is a calibrator product for an in-vitro diagnostic assay, not an algorithm.

7. The Type of Ground Truth Used

• Analytical Traceability to International Standard complemented by Internal Referencing: The assigned value of C-peptide in the primary reference material (which is then used to assign values to the calibrators) was based on WHO 1ª IRP 84/510. This is an internationally recognized reference preparation for C-peptide. Subsequent secondary reference materials and product calibrators are assigned values using Tosoh AIA instruments, comparing measured results with those obtained with previous lots or a primary reference.

8. The Sample Size for the Training Set

• Not applicable. This is a calibrator set, not an AI or machine learning model that requires a training set. The values are assigned based on analytical methods and traceability, not learned from data.

9. How the Ground Truth for the Training Set Was Established

• Not applicable, as there is no "training set." The "ground truth" for the calibrator values is established through the analytical traceability described in point 7.

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