Search Results

Regulation Number

Type

Panel

Audit MicroControls Linearity LQ Cystatin-C

Reference & Predicate Devices

K130762

Intended Use

The Audit® MicroControls™ Linearity DROP LQ Blood Glucose is intended to simulate human patient samples for use as assayed quality control material, determining linearity, calibration, and the verification of reportable range for the glucose analyte.

The Audit® MicroControls™ Linearity DROP LQ Blood Glucose is for In Vitro Diagnostic use only.

Device Description

The Audit® MicroControls™ Linearity DROP LQ Blood Glucose is an in-vitro diagnostic device consisting of sets of 5 levels of liquid, linearity material and additives in human based serum. The product contains the following analyte: glucose. Each set consists of 5 levels labeled Level A, B, C, D and E. Each level has a fill size of 1ml. Materials of human origin used in the manufacture of this linearity set have been tested using FDA approved methods and are found to be non-reactive for HbsAg and antibodies to HCV and HIV-1/2.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Audit® MicroControls™ Linearity DROP LQ Blood Glucose device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides acceptance criteria for stability claims rather than performance metrics like sensitivity or specificity.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance/Met
Shelf Life	2 years, when stored unopened at 2-8º C	Met
Open Vial Stability	7 days, when stored tightly capped at 2-8º C	Met

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

The document mentions that multiple measurements were taken for the analyte at each level during value assignment and stability studies. However, specific sample sizes for a "test set" (e.g., number of unique samples or runs for a formal validation study) are not explicitly provided.
Data Provenance: The studies were conducted internally by Aalto Scientific, Ltd. The data is retrospective for the completed accelerated stability study and real-time open vial stability, and prospective for the ongoing real-time shelf-life study. The country of origin of the data is not explicitly stated but can be inferred as the USA, where Aalto Scientific, Ltd. is located.

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

This information is not applicable in the context of this device. The device is a quality control material used to verify the linearity, calibration, and reportable range of blood glucose measurement systems. The "ground truth" for this type of device is established through analytical value assignment based on measurements performed on a reference instrument, not through human expert interpretation of results.
The document states: "Analyte value assignment for Level A through Level E was performed on Roche Cobas for the blood glucose analyte using the corresponding reagent. The analyte was measured multiple times. The mean value of the analyte was used to establish a target concentration value at each level."

4. Adjudication Method for the Test Set

Not applicable. As the device is a quality control material and "ground truth" is established through analytical measurement, there is no human-based adjudication process for a test set in the conventional sense. The "adjudication" is inherent in the analytical measurement and statistical determination of mean values.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically relevant for interpretative diagnostic devices (e.g., imaging AI) where human readers are making diagnoses. The Audit® MicroControls™ Linearity DROP LQ Blood Glucose is a quality control material for analytical instruments, not an interpretative device.

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

Not applicable. This device is a control material, not an algorithm. Therefore, "standalone performance" in the context of an algorithm's accuracy without human intervention is not relevant. Its performance is measured by its stability and its ability to produce expected values when analyzed by a blood glucose measurement system.

7. The Type of Ground Truth Used

The ground truth (or target values) for the device's glucose levels was established through analytical measurement on a reference instrument (Roche Cobas c501) with multiple measurements and calculation of the mean value. This is essentially an instrument-based reference value rather than expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

Not explicitly stated and not directly applicable as this is a physical control material, not an AI/ML algorithm. The concept of a "training set" is typically used for machine learning models. For this device, the equivalent would be the data used for the "value assignment" to establish its target concentrations. The document mentions "The analyte was measured multiple times" for value assignment, but a specific number is not given.

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

As explained in Point 7, the "ground truth" (target values) for the device's five levels (A-E) was established through repeated analytical measurements of the glucose analyte on a Roche Cobas c501 instrument. The mean of these multiple measurements was used to define the target concentration value for each level. Raw materials are subject to internal quality control.

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K Number

K143571

Device Name

Manufacturer

AALTO SCIENTIFIC, LTD.

Date Cleared

2015-01-23

(37 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

Audit MicroControls Linearity FD Tumor Markers II

Intended Use

The Linearity LQ Cystatin-C is an assayed quality control material intended to simulate human patient samples for use in determining linearity, calibration, and the verification of reportable range for the Cystatin-C analyte.

The Linearity LQ Cystatin-C is for In Vitro Diagnostic use only.

Device Description

The Audit® MicroControls™ Linearity LQ Cystatin-C product is an in-vitro diagnostic device consisting of one set of five levels of liquid, linearity/QC material. For the set there are five levels labeled A, B, C, D and E. The set contains 1ml for each level. The set contains the Cystatin-C analyte and additives in human and bovine based serum. Materials of human origin used in the manufacture of this linearity set have been tested using FDA approved methods and are found to be non-reactive for HbsAg and antibodies to HCV and HIV-1/2.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided document:

This document is a 510(k) Premarket Notification for a Linearity LQ Cystatin-C quality control material (device). The goal of the submission is to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Study	Acceptance Criteria	Reported Device Performance
Shelf Life (Unopened)	Product claims: 3 years, when stored unopened at 2-8°C.	Accelerated stability studies were conducted to establish the shelf life stability claims. Acceptance criteria were met to support the product claims of 3 years, when stored unopened at 2-8°C. (Real-time studies are ongoing).
Open Vial Stability	Product claims: Once a vial has been opened, the product will be stable for 30 days when stored tightly capped at 2-8°C.	Real-time stability studies conducted at the end of accelerated stability studies. Acceptance criteria were met to support the product claims of 30 days when stored tightly capped at 2-8°C.
Target Ranges for Cystatin-C	Target ranges for each of the 5 levels were calculated as ± 10% of the target value. (Implied: Measured values should fall within these ranges).	The mean value of the Cystatin-C analyte was used to establish target concentration value at each level. The target ranges for Cystatin-C (in mg/L) for each level are:

Level A: 0.584-0.714 (Target 0.649)
Level B: 2.09-2.56 (Target 2.33)
Level C: 3.69-4.51 (Target 4.10)
Level D: 5.08-6.21 (Target 5.65)
Level E: 6.44-7.87 (Target 7.15) |
| Non-reactivity for Infectious Disease Markers | Human-origin materials used must be tested using FDA approved methods and found to be non-reactive for HbsAg and antibodies to HCV and HIV-1/2. | Materials of human origin used in the manufacture of this linearity set have been tested using FDA approved methods and are found to be non-reactive for HbsAg and antibodies to HCV and HIV-1/2. |

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

This document describes a quality control material used for linearity, calibration verification, and reportable range for a specific analyte (Cystatin-C). It's not a diagnostic device with a "test set" in the traditional sense of patient data.

Test Set Description: The "test set" here refers to the actual device (Linearity LQ Cystatin-C) which comes in five levels (A, B, C, D, E) of a liquid material. Each level contains 1ml.
Sample Size:
- For stability studies: Vials from two lots of finished product were used for real-time stability (stored at 2-8℃ and -80℃). Measurements were taken at two different time points. The analyte values from these vials were tested in duplicate.
- For value assignment: The Cystatin-C analyte was measured multiple times.
Data Provenance: The document does not specify the country of origin of the data. The studies were conducted by Aalto Scientific, Ltd., located in Carlsbad, CA. These are prospective studies performed to characterize the device's stability and assigned values.

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

This type of device (quality control material) does not typically involve human "experts" establishing a ground truth for a test set in the way a diagnostic algorithm for medical images would. Instead, the ground truth (target concentration values) is established through technical laboratory measurements.

Number of Experts: Not applicable.
Qualifications: Not applicable. The "ground truth" (target values) is established through analytical testing methods on a specific instrument.

4. Adjudication Method for the Test Set

Not applicable. As described above, this is not a diagnostic device where patient cases are reviewed and adjudicated. The "ground truth" (target analyte concentrations) for the quality control material is inherent to its formulation and confirmed through laboratory measurements.

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 a quality control material, not an AI-powered diagnostic device, and therefore no MRMC study was conducted or relevant.

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

Not applicable. This is a laboratory quality control material, not an algorithm or AI.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth used for this device, the Audit® MicroControls™ Linearity LQ Cystatin-C, is analytical reference measurement. Specifically:

Analyte Value Assignment: "The mean value of the Cystatin-C analyte was used to establish target concentration value at each level." This refers to the measured concentration on a reference instrument (Beckman Immage) using a specific reagent.
Stability: Measured values at different time points and storage conditions are compared against initial or expected values established through analytical testing.

8. The Sample Size for the Training Set

Not applicable. This is a quality control material, not a machine learning algorithm, and therefore does not have a "training set."

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

Not applicable. As there is no training set for this type of device, the concept of establishing ground truth for it does not apply.

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K Number

K143573

Device Name

Manufacturer

Audit MicroControls Linearity FD Unsaturated Iron Binding Capacity

Date Cleared

2015-01-16

(30 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K082717

Intended Use

The Linearity FD Tumor Markers II is an assayed quality control material intended to simulate human patient samples for use in determining linearity, calibration, and the verification of reportable range for the following analytes: Alpha fetoprotein (AFP), Carcinoembryonic antigen (CEA), Prostate-specific antigen-total (PSA), Carbonic Anhydrase-125 (CA-125), Carbonic Anhydrase 19-9 (CA19-9), Carbonic Anhydrase 27-29 (CA27-29)(BR), free-PSA (fPSA), and Carbonic Anhydrase 15-3 (CA15-3).

The Linearity FD Tumor Markers II is for In Vitro Diagnostic use only.

Device Description

The Audit® MicroControls™ Linearity FD Tumor Markers II product is an in-vitro diagnostic device consisting of two sets of five levels of liquid, linearity/QC material. Set 1 contains the analytes: Alpha fetoprotein (AFP), Carcinoembryonic antigen (CEA), Prostate-specific antigentotal (PSA), Carbonic Anhydrase-125 (CA-125), Carbonic Anhydrase 19-9 (CA19-9), and Carbonic Anhydrase 27-29 (CA27-29) (BR) and additives in human serum. Set 2 contains the analytes: free-PSA (fPSA), and Carbonic Anhydrase 15-3 (CA15-3) and additives in human serum and bovine serum. For each set there are five levels labeled A, B, C, D and E. Both sets contain 1ml for each level. Materials of human origin used in the manufacture of this linearity set have been tested using FDA approved methods and are found to be non-reactive for HbsAg and antibodies to HCV and HIV-1/2.

AI/ML Overview

This document is a 510(k) summary for the Audit® MicroControls™ Linearity FD Tumor Markers II, a quality control material. It describes the device's intended use and compares it to a predicate device (K082717 Audit® MicroCV™ Tumor Markers Linearity Set). The primary focus of the performance data section is on stability studies and value assignment, not diagnostic accuracy or comparative effectiveness with human readers.

Here's an analysis of the provided information concerning acceptance criteria and study details:

1. A table of acceptance criteria and the reported device performance

The document outlines acceptance criteria for stability (shelf life and reconstituted vial stability) and expected value ranges for various analytes.

Acceptance Criteria and Reported Device Performance

Feature/Analyte	Acceptance Criteria	Reported Device Performance
Shelf Life	Not explicitly stated as a numerical criterion, but implies meeting product claims.	2 years, when stored unopened at 2-8°C. (Supported by accelerated stability studies).
Reconstituted Stability	Not explicitly stated as a numerical criterion, but implies meeting product claims.	14 days when stored tightly capped at 2-8°C. (Supported by accelerated stability + real-time stability studies).
Expected Values (General)	Target ranges calculated as +/-20% of the target mean values.	All analytes (AFP, CEA, PSA, CA125, CA27-29 (BR), CA15-3, CA19-9, fPSA) were assigned target values and corresponding target ranges (e.g., AFP: 8.2 ng/ml target, 6.5-9.8 ng/ml range). Specific values are provided in the tables within the document.
Real-time Stability (% Difference)	% difference of real-time mean values compared to Day0 mean value is within "the acceptance criteria" (specific numerical criterion not provided).	Studies are ongoing. Suggests initial results met internal acceptance criteria for the time points tested.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Test Set Sample Size: The document does not specify a "test set" in the context of diagnostic accuracy. The performance data focuses on stability and value assignment of the quality control material itself.
- For accelerated stability, it mentions "All supporting data is retained on file at Aalto Scientific, Ltd." but doesn't quantify the number of samples or lots.
- For real-time stability, it states "Vials from two lots of finished product are stored at 2-8℃ (real time vials) and -80℃ (Dayl vials). Samples are taken at two different time points."
- For value assignment, it mentions each analyte was "measured multiple times" on specific instruments (Siemens Advia Centaur and Abbott Architect i1000SR).
Data Provenance: The studies were conducted by Aalto Scientific, Ltd., located in Carlsbad, CA, USA. The data would therefore be considered prospective as it relates to the manufacturing and testing of their product. The matrix for the product uses "Human Based Serum and bovine based serum," but this refers to the components of the QC material itself, not patient samples.

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 section is not applicable to this document. The device is a quality control material, not a diagnostic device that requires expert interpretation of results for ground truth. The "ground truth" for the QC material is its assigned target values based on measurements by calibrated instruments and established reference methods (implied through the use of specific analyzers and reagents).

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

This section is not applicable. There is no "test set" in the context of diagnostic performance requiring adjudication.

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

This section is not applicable. The device is a quality control material, not an AI-assisted diagnostic tool.

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

This section is not applicable. The device is a quality control material, not an algorithm. What might be considered "standalone performance" for this device is its ability to maintain its assigned values over time (stability) and the accuracy of its initial value assignments, which are demonstrated through the described studies.

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

For this quality control material, the "ground truth" is established through:

Reference Instrument Measurement: Analytes were measured multiple times on specific, high-precision clinical chemistry analyzers (Siemens Advia Centaur and Abbott Architect i1000SR) using corresponding reagents. These instruments themselves are calibrated against established reference standards.
Mean Value Calculation: The mean value of multiple measurements for each analyte at each level was used to establish the "target concentration value."

8. The sample size for the training set

This section is not applicable. This device is not an AI algorithm and therefore does not have a "training set" in the conventional sense. The development of the QC material involves formulation and initial testing, but not machine learning training.

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

This section is not applicable for the same reasons as point 8.

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K Number

K143026

Device Name

Manufacturer

Date Cleared

2014-11-21

(31 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

Audit MicroControls Linearity LQ Special Diabetes

Intended Use

The Linearity FD Unsaturated Iron Binding Capacity is an assayed quality control material intended to simulate human patient samples for use in determining linearity, calibration, and the verification of reportable range for unsaturated iron binding capacity.

Linearity FD Unsaturated Iron Binding Capacity is for In Vitro Diagnostic use only.

Device Description

Audit® MicroControls™ Linearity FD Unsaturated Iron Binding Capacity product is an in-vitro diagnostic device consisting of five levels of freeze dried, linearity/QC material, containing additives in human serum. There are five levels labeled A,B,C,D and E which contain 1ml for each level.

AI/ML Overview

The provided document is a 510(k) premarket notification decision letter from the FDA for the Audit® MicroControls™ Linearity FD Unsaturated Iron Binding Capacity device. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain a detailed study proving the device meets acceptance criteria in the way typically expected for a diagnostic or AI-driven medical device.

The document primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device (K130157 Audit® MicroCV™ Beta-Hydroxybutyric Acid Linearity Set) based on similar intended use and technical characteristics. It mentions performance data related to stability and value assignment, but not clinical performance with respect to patient outcomes or comparison against a diagnostic gold standard in a traditional clinical study.

Here's an attempt to extract and organize the information based on your request, with significant caveats that much of the requested information (especially for AI/ML device performance) is not present in this type of regulatory submission for a quality control material:

Device Name: Audit® MicroControls™ Linearity FD Unsaturated Iron Binding Capacity

Device Type: Assayed Quality Control Material for Unsaturated Iron Binding Capacity (UIBC)

Intended Use: To simulate human patient samples for use in determining linearity, calibration verification, and the verification of reportable range for unsaturated iron binding capacity. For In Vitro Diagnostic use only.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this device (a quality control material), the "acceptance criteria" and "device performance" are primarily related to its stability and its ability to provide target values within a specified range, demonstrating linearity. This is not a diagnostic device with performance metrics like sensitivity, specificity, or AUC.

Acceptance Criteria Category	Specific Criteria/Metric	Reported Device Performance/Status
Shelf Life Stability	Not explicitly stated as a numerical criterion in % difference, but implied "within acceptance criteria" for comparison of real-time vials to Day0 values.	- Accelerated Stability: Met acceptance criteria to support 24 months shelf life.

Real-Time Stability: Ongoing studies, but "product is determined to meet its predicted shelf life if the % difference of the real-time mean values compared to the Day0 mean value is within the acceptance criteria." (indicating current data supports predicted shelf life)
Claimed Shelf Life: 24 months, when stored unopened at 2-8°C. |
| Reconstituted Vial Stability | Not explicitly stated as a numerical criterion, but implied "within acceptance criteria." | - Accelerated + Real-Time Stability: Met acceptance criteria.
Claimed Reconstituted Vial Stability: 30 days when stored tightly capped at 2-8°C. |
| Value Assignment / Linearity | Target ranges for each of the five levels (calculated as +/-15% of the target mean values). | Individual analyte values for Level A through Level E were measured multiple times on a Hitachi P-Modular analyzer. The mean value of UIBC was used to establish target values.
Reported Target Values and Ranges (µg/dL):
Level A: Target 75.7 (Range 64.4-87.1)
Level B: Target 185.5 (Range 157.7-213.4)
Level C: Target 297.3 (Range 252.7-341.9)
Level D: Target 403.7 (Range 343.2-464.3)
Level E: Target 525.1 (Range 446.3-603.8) |
| AMR (Analytical Measuring Range) | Not explicitly stated as an "acceptance criterion" but reported as a characteristic. | Unsaturated Iron Binding Capacity: 10-500 µg/dL. This range encompasses the target values of the linearity levels. |

Information Not Applicable or Not Provided in this Document:

The following points are typically relevant for AI/ML-driven diagnostic devices or clinical studies, which are not the subject of this 510(k) for a quality control material. Therefore, the requested information is either not applicable or not provided in this submission.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable for a QC material in this context. The "test sets" would refer to analytical samples used for stability and value assignment, not patient data for diagnostic evaluation. The document mentions "samples are taken at four different time points" for real-time stability and "each analyte was measured multiple times" for value assignment.
Data Provenance: The studies were conducted internally by Aalto Scientific, Ltd. (Carlsbad, CA, USA).

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. "Ground truth" in the clinical diagnostic sense is not established for a quality control material. The "truth" here relates to the analytical value determined by the reference method (Hitachi P-Modular) and the stability performance compared to a baseline.

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

Not applicable. No expert adjudication process is described for this type of analytical validation.

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/ML device or a diagnostic device requiring human interpretation.

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

Not applicable. This is a quality control material, not an algorithm.

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

The "ground truth" for the performance of this quality control material is its analytical value as determined by a reference laboratory instrument (Hitachi P-Modular) and its demonstrated stability over time according to pre-defined internal acceptance criteria. It is an analytical "truth," not a clinical "ground truth."

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a "training set." The measurements for stability and value assignment are based on multiple replicates as described in the methodology.

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

Not applicable. (See point 8).

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K Number

K142978

Device Name

Manufacturer

Date Cleared

2014-11-20

(36 days)

Product Code

JJY

Regulation Number

Type

Panel

Reference & Predicate Devices

AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET

Intended Use

The Linearity LQ Special Diabetes is an assayed quality control material intended to simulate human patient samples for use in determining linearity, calibration, and the verification of reportable range for the following analytes: fructosamine, insulin, and C-peptide.

Linearity LQ Special Diabetes is for In Vitro Diagnostic use only.

Device Description

The Audit® MicroControls™ Linearity LQ Special Diabetes product is an in-vitro diagnostic device consisting of five levels of liquid, linearity/QC material, containing Fructosamine, Insulin, C-peptide and additives in human serum. There are five levels labeled A, B, C, D and E which contain 2ml for each level.

Materials of human origin used in the manufacture of this linearity set have been tested using FDA approved methods and are found to be non-reactive for HbsAg and antibodies to HCV and HIV-1/2.

AI/ML Overview

This document describes the 510(k) summary for the Audit® MicroControls™ Linearity LQ Special Diabetes device. This device is an assayed quality control material intended to simulate human patient samples for use in determining linearity, calibration verification, and the verification of the reportable range for fructosamine, insulin, and C-peptide.

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on the stability (shelf life and open vial stability) and value assignment (expected range) as performance criteria.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Shelf Life Stability	Product claims supported by accelerated stability studies.	18 months, when stored unopened at 2-8°C.
Open Vial Stability	Product claims supported by accelerated + real-time stability studies.	14 days, when stored tightly capped at 2-8°C, once opened.
Value Assignment (Analytes)	Target ranges calculated as +/-15% of the target mean values.
Fructosamine (µmol/L):

Level A: Target 24.10 (Range 20.49-27.72)
Level B: Target 258.25 (Range 219.52-296.99)
Level C: Target 496.44 (Range 421.97-570.91)
Level D: Target 748.14 (Range 635.92-860.36)
Level E: Target 975.70 (Range 829.35-1122.06)

Insulin (µU/mL):

Level A: Target 1.37 (Range 1.17-1.58)
Level B: Target 233.78 (Range 198.71-268.85)
Level C: Target 456.20 (Range 387.77-524.63)
Level D: Target 628.08 (Range 533.87-722.29)
Level E: Target 814.79 (Range 692.57-937.00)

C-peptide (ng/mL):

Level A: Target 0.32 (Range 0.27-0.37)
Level B: Target 9.27 (Range 7.88-10.66)
Level C: Target 18.22 (Range 15.49-20.96)
Level D: Target 26.96 (Range 22.91-31.00)
Level E: Target 35.37 (Range 30.07-40.68) |

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

Sample Size:
- Shelf Life - Real Time Stability: Vials from two lots of finished product. Samples taken at 9 months, 18 months, and 19 months.
- Value Assignment/Linearity: Implicitly, the "five levels labeled A, B, C, D and E" of the device itself are the samples for which values are assigned. Each analyte was "measured multiple times" at each level.
Data Provenance: Not explicitly stated regarding country of origin, but the company is Aalto Scientific, Ltd. in Carlsbad, CA. The context is a 510(k) submission to the US FDA. The studies appear to be prospective as they involve accelerated and real-time stability studies with samples taken over time.

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

This information is not provided in the document. The "ground truth" for value assignment seems to be established internally by Aalto Scientific, Ltd. through multiple measurements on specific analytical instruments (Roche Modular P and Roche Cobas e411). There is no mention of external experts or their qualifications for establishing these values.

4. Adjudication Method for the Test Set:

This information is not provided. The value assignment appears to be based on "mean value of the analyte," indicating an averaging approach rather than an adjudication among multiple independent assessments.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. This device is an in-vitro diagnostic quality control material, not a diagnostic imaging or AI-driven interpretative device that would typically involve human readers. Therefore, the concept of human readers improving with or without AI assistance is not applicable here.

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

Yes, in essence. The performance data presented (stability and value assignment) describes the intrinsic characteristics of the linearity material itself when measured on laboratory instruments. This is analogous to a "standalone" assessment of the material's properties without human interpretative intervention beyond operating the instruments and recording results. The device's "performance" is its ability to maintain its target values and linearity, which is assessed directly by analytical measurements.

7. The Type of Ground Truth Used:

The ground truth used for value assignment and stability assessment appears to be analytical measurements obtained from established, FDA-approved methods on specific laboratory instruments (Roche Modular P for Fructosamine, Roche Cobas e411 for Insulin and C-peptide). For stability, the "Day0 vials" serve as the baseline ground truth reference for comparison with real-time samples.

8. The Sample Size for the Training Set:

This information is not applicable as this device is a quality control material and not an AI/ML algorithm that requires a "training set." The materials used for "value assignment" and "stability studies" are the product itself across different levels and time points.

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

This information is not applicable for the same reason as above. There is no training set for this type of device. The ground truth for the device's characteristics (analyte concentrations at each level) is established by multiple analytical measurements on a specified instrument, and the mean value is used.

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K Number

K130762

Device Name

Manufacturer

Date Cleared

2013-04-29

(40 days)

Product Code

JJY

Regulation Number

Type

Panel

AUDIT MICROCV VITAMIN D LINEARITY SET

Reference & Predicate Devices

K082714

Intended Use

The Audit® MicroCV™ Therapeutic Drug (TDM) Linearity Set is an assayed quality control material consisting of five levels of human based serum. Each level contains: Acetaminophen, Amikacin, Carbamazepine, Digoxin, Gentamicin, Lithium, Methotrexate, Phenobarbitol, Pheytoin, Quinidine, Salicylate, Theophylline, Tobramycin, Valporic Acid and Vancomycin. These five levels demonstrate a linear relationship to each other for their respective analytes. It is intended to simulate human patient serum samples for purpose of determining linearity, calibration verification of reportable range for Acetaminophen, Amikacin, Carbamazepine, Digoxin, Gentamicin, Lithium, Methotrexate, Phenobarbitol, Pheytoin, Quinidine, Salicylate, Theophylline, Tobramycin, Valporic Acid and Vancomycin.

The product is intended for use with quantitative assays on the indicated analyzer provided in the labeling and may be used as quality control material for these analytes. When used for quality control purposes, it is recommended that each laboratory establish its own means and acceptable ranges and use the values provided only as guides. The Audit® MicroCV™ Therapeutic Drug (TDM) Linearity Set should not be used for calibration or standardization of the Acetaminophen, Amikacin, Carbamazepine, Digoxin, Gentamicin, Lithium, Methotrexate, Phenobarbitol, Pheytoin, Quinidine, Salicylate, Theophylline, Tobramycin, Valporic Acid and Vancomycin assays. The Audit® MicroCV™ Therapeutic Drug (TDM) Linearity Set is "For In Vitro Diagnostic Use Only".

Device Description

The Audit® MicroCV™ Therapeutic Drug (TDM) Linearity Set is an in-vitro diagnostic device consisting of five levels of Lyophilized linearity material containing Acetaminophen, Amikacin, Carbamazepine, Digoxin, Gentamicin, Lithium, Methotrexate, Phenobarbitol, Pheytoin, Quinidine, Salicylate, Theophylline, Tobramycin, Valporic Acid and Vancomycin and additives in human serum. There are five vials labeled A, B, C, D, and E, and contain 5 mL for each level.

Materials of human origin used in the manufacture of this linearity set has been tested using FDA approved methods and found to be non-reactive for HbsAg and antibodies to HCV and HIV-1/2.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Audit® MicroCV™ Therapeutic Drug (TDM) Linearity Set, based on the provided text:

Acceptance Criteria and Device Performance

The core acceptance criterion for the Audit® MicroCV™ Therapeutic Drug (TDM) Linearity Set is the demonstration of linearity.

Acceptance Criterion	Reported Device Performance
Five-point linear regression value > 0.90	The study confirms that if the five-point linear regression value is greater than 0.90, and the plots are linear, then the products demonstrate linearity. This indicates that the device's performance met this criterion.
Plots are linear	The study confirms that if the five-point linear regression value is greater than 0.90, and the plots are linear, then the products demonstrate linearity. This indicates that the device's performance met this criterion.

Note: The document explicitly states: "If the five-point linear regression value is greater than 0.90 and if the plots are linear then the products demonstrate linearity." This phrasing indicates these are the conditions for acceptance and that the device met these conditions.

Study Details

This device is an in-vitro diagnostic quality control material, not an AI or imaging device, so many of the requested categories (like MRMC studies, experts for ground truth, adjudication methods, or separate training/test sets for an algorithm) are not applicable in the typical sense. The study focused on demonstrating the linearity of the control material and its stability.

Sample size used for the test set and data provenance:
- Sample Size: Each analyte was measured 5 times (5 separate vials) at each of the five levels (A through E).
- Data Provenance: Not explicitly stated, but implies internal testing by Aalto Scientific, Ltd. The information available does not indicate country of origin for the data (beyond the company location being Carlsbad, CA) or whether it was retrospective or prospective in the context of human patient data. It is a prospective analytical study performed on the device itself.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is a linearity control material. The "ground truth" (target concentration values) was established through repeated measurements on specified instruments (Abbott Axsym and Roche Hitachi 911) using specific reagents. This involves highly trained laboratory personnel but not "experts" in the sense of clinical interpretation for an AI device.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. The data generation was quantitative measurement. The mean value of five measurements was used to establish the target concentration, which is a statistical method, not an adjudication process.
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 or imaging device with human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical quality control material, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for each level's concentration was established by mean concentration values from 5 replicate measurements performed on specified laboratory instruments (Abbott Axsym and Roche Hitachi 911) using appropriate reagents. This is effectively an instrument-derived quantitative reference value.
The sample size for the training set:
- Not applicable as there is no "training set" in the context of an algorithm.
How the ground truth for the training set was established:
- Not applicable.

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K Number

K130764

Device Name

Manufacturer

Date Cleared

2013-04-26

(37 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K101427

Intended Use

The Audit® MicroCV™ Vitamin D Linearity Set is an assayed quality control material consisting of five levels of human and equine based serum. Each level contains Vitamin D. These five levels demonstrate a linear relationship to each other for Vitamin D. It is intended to simulate human patient serum samples for purpose of determining linearity, calibration verification and verification of reportable range for Vitamin D.

The product is intended for use with quantitative assays on the indicated analyzer provided in the labeling and may be used as quality control material for Vitamin D. When used for quality control purposes, it is recommended that each laboratory establish its own means and acceptable ranges and use the values provided only as guides. The Audit® MicroCV™ Vitamin D Linearity Set should not be used for calibration or standardization of the Vitamin D assay. The Audit® MicroCV™ Vitamin D Linearity Set is "For In Vitro Diagnostic Use Only".

Device Description

The Audit® MicroCV™ Vitamin D Linearity Set is an assayed quality control material consisting of five levels of human and equine based serum, with each level containing Vitamin D. It is used to confirm the proper calibration, linear operating range, and reportable range of Vitamin D. Level A is near the lower limit level and Level E has concentrations near the upper limit of instruments. Levels B - D are related by linear dilution of Level A and Level E.

AI/ML Overview

{
  "1": {
    "title": "Acceptance Criteria and Reported Device Performance for Audit® MicroCV™ Vitamin D Linearity Set",
    "table": {
      "headers": [
        "Vitamin D (ng/mL)",
        "Level A",
        "Level B",
        "Level C",
        "Level D",
        "Level E"
      ],
      "rows": [
        [
          "Target value",
          "20.18",
          "46.57",
          "77.68",
          "107.32",
          "135.72"
        ],
        [
          "Target Range",
          "17.15-23.21",
          "39.58-53.55",
          "66.03-89.33",
          "91.22-123.42",
          "115.36-156.08"
        ]
      ]
    },
    "notes": "The provided document specifically details the 'Expected Values' for the Audit® MicroCV™ Vitamin D Linearity Set. These expected values and their target ranges serve as the reported device performance and implicitly, the acceptance criteria for the linearity of the Vitamin D measurements across the five levels (A-E) on the Advia Centaur instrument using Siemens Reagent. The product is intended to demonstrate a linear relationship between these levels."
  },
  "2": "The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It mentions that stability studies and value assignments were performed and that 'All supporting data is retained on file at Aalto Scientific, Ltd.'",
  "3": "The document does not specify the number of experts used to establish the ground truth for the test set or their qualifications.",
  "4": "The document does not specify an adjudication method for the test set.",
  "5": "A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a quality control material, not an AI-assisted diagnostic tool for human readers.",
  "6": "A standalone performance study was not explicitly described as 'algorithm only without human-in-the-loop performance'. The context is a quality control material for an instrument, not a standalone algorithm in the typical AI sense.",
  "7": "The type of 'ground truth' for the expected values appears to be established through 'Value assignment' performed by the manufacturer, implying internal testing and validation against established laboratory methods or reference materials. It's described as 'Expected Values' determined for the Audit® MicroCV™ Vitamin D Linearity Set, suggesting a form of expert consensus or manufacturer-defined reference values for the particular instrument/reagent combination.",
  "8": "The document does not specify the sample size for the training set.",
  "9": "The document does not detail how the ground truth for a training set (if applicable) was established. The focus is on establishing expected values and stability for the quality control material itself."
}

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K Number

AUDIT MICROCV BETA-HYDROXYBUTYRIC ACID LINEARITY SET

Device Name

Manufacturer

Date Cleared

2013-03-19

(55 days)

Product Code

Regulation Number

Type

Panel

AUDIT MICROLQ SPINAL FLUID CONTROL

Reference & Predicate Devices

K101427

Intended Use

The Audit® MicroCV™ Beta-Hydroxybutyric Acid Linearity Set is an assayed quality control material consisting of five levels of human based serum. Each level contains Beta- Hydroxybutyric Acid. These five levels demonstrate a linear relationship to each other for Beta-Hydroxybutyric Acid. It is intended to simulate human patient serum samples for purpose of determining linearity, calibration verification and verification of reportable range for Beta- Hydroxybutyric Acid.

The product is intended for use with quantitative assays on the indicated analyzer provided in the labeling and may be used as quality control material for Beta-Hydroxybutyric Acid. When used for quality control purposes, it is recommended that each laboratory establish its own means and acceptable ranges and use the values provided only as guides. The Audit® MicroCV™ Beta- Hydroxybutyric Acid Linearity Set should not be used for calibration or standardization of the Beta- Hydroxybutyric Acid assay. The Audit® MicroCV™ Beta- Hydroxybutyric Acid Linearity Set is "For In Vitro Diagnostic Use Only".

Device Description

The Audit® MicroCV™ Beta-Hydroxybutyric Acid Linearity Set is an assayed quality control material consisting of five levels of human based serum, with each level containing Beta-Hydroxybutyric Acid. It is used to confirm the proper calibration, linear operating range, and reportable range of Beta-Hydroxybutyric Acid. Level A is near the lower limit level and Level E has concentrations near the upper limit of instruments. Levels B - D are related by linear dilution of Level A and Level E.

AI/ML Overview

The provided document is a 510(k) Summary for a medical device (Audit® MicroCV™ Beta-Hydroxybutyric Acid Linearity Set), which describes the device's intended use, performance data, and comparison to a predicate device. It is a regulatory submission, not a study report that details the methodology and results of a device's performance against specific acceptance criteria in the manner requested.

Therefore, many of the specific details for acceptance criteria and the study that proves the device meets them, especially those pertaining to clinical performance with human readers, ground truth establishment for AI models, and comparative effectiveness studies, cannot be extracted directly from this document. This document is focused on the analytical performance of a quality control material rather than the clinical performance of a diagnostic device.

However, I can extract the information relevant to the analytical performance as described in the document.

Here's an analysis based on the provided text:

Device: Audit® MicroCV™ Beta-Hydroxybutyric Acid Linearity Set

Device Type: Assayed quality control material for Beta-Hydroxybutyric Acid.

Purpose: To confirm proper calibration, linear operating range, and reportable range of Beta-Hydroxybutyric Acid assays.

1. Table of Acceptance Criteria and Reported Device Performance

The document provides "Product claims" based on stability studies and expected values. These claims serve as the performance characteristics. Explicit "acceptance criteria" for linearity or other analytical parameters are not detailed in this summary, but the "Target Range" for expected values implicitly reflects acceptable performance for value assignment.

Performance Characteristic	Acceptance Criteria (Implicit from "Product Claims")	Reported Device Performance
Open Vial Stability	Stable for 40 days when stored tightly capped at 2 - 8° C	Stable for 40 days at 2 - 8° C
Shelf Life	Two years, when stored unopened at 2 - 8° C	Two years, when stored unopened at 2 - 8° C (Note: Real time studies ongoing)
Expected Values (B-HB, mmol/L)	Within specified Target Ranges for each level
Level A (Target Value)	0.0 (Target Range)	0.0
Level B (Target Value)	1.2 (Target Range: 1.0-1.4)	1.2
Level C (Target Value)	2.3 (Target Range: 2.0-2.6)	2.3
Level D (Target Value)	3.4 (Target Range: 2.9-3.9)	3.4
Level E (Target Value)	4.4 (Target Range: 3.8-5.1)	4.4

Note: The document states, "When used for quality control purposes, it is recommended that each laboratory establish its own means and acceptable ranges and use the values provided only as guides." This indicates that the "Target Range" is a guide for expected values, and laboratories would define their specific acceptance criteria based on their analytical system.

Regarding the study that proves the device meets acceptance criteria:

The document refers to "Stability studies" and "Value assignment" studies. These are analytical studies, not clinical studies.

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

Test Set Sample Size: Not explicitly stated. The document mentions "five levels of human based serum" for the linearity set. For stability studies, the number of samples or experimental replicates is not provided.
Data Provenance: Not explicitly stated for the test data (e.g., country of origin). The material itself is "human based serum." The studies were performed by Aalto Scientific, Ltd. in Carlsbad, CA, US, suggesting the data originates there.
Retrospective/Prospective: Not specified, but stability studies typically involve prospective real-time testing, while value assignment could be either.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable as the device is a quality control material for analytical assays, not a diagnostic device requiring expert interpretation of clinical data. The "ground truth" here is the assigned analytical value of Beta-Hydroxybutyric Acid.

4. Adjudication method for the test set

Not applicable for this type of analytical device. Ground truth for value assignment is established through laboratory methods, not expert adjudication.

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 a linearity set for an analytical instrument, not an AI-assisted diagnostic tool.

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

Not applicable. This device is not an algorithm or AI.

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

The ground truth for the expected values of Beta-Hydroxybutyric Acid in the linearity set samples is established through analytical testing/value assignment using quantitative assays on an indicated analyzer (e.g., "P-Modular Instrument, Roche Reagent" is mentioned for the values). This involves precise laboratory measurements.

8. The sample size for the training set

Not applicable as this is not an algorithm/AI model that requires training data. The "training" for this product would be the manufacturing and quality control processes to ensure consistency.

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

Not applicable as this is not an algorithm/AI model. The "ground truth" for the manufactured product's components and values would be established through standard analytical chemistry and manufacturing quality control procedures.

Summary of Limitations Based on Document Content:

The provided 510(k) summary focuses on the analytical performance and stability of a quality control material. It does not contain information about clinical studies, diagnostic accuracy, human reader performance, AI algorithms, or "ground truth" established by clinical experts, which are typical expectations for the detailed questions provided. The data presented is intended to demonstrate the material's suitability for its stated purpose in verifying the performance of Beta-Hydroxybutyric Acid assays.

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K Number

K112742

Device Name

Manufacturer

Date Cleared

2012-06-15

(268 days)

Product Code

JJY

Regulation Number

Type

Panel