Search Results

Regulation Number

Type

Panel

Liquichek Cardiac Markers Plus Control LT

Reference & Predicate Devices

K150226,K130236,K980135,K130415,K051928,K051968,K091225

Intended Use

For in vitro diagnostic use. Verification Kits VK-3, VK-4, VK-R5, VK-R7 and VK-Crea are assayed quality control systems for calibration verification for the parameters and the analyzers listed in the insert specifying the control ranges.

Device Description

VK-3 Verification Kit is a calibration verification kit consisting of the following 5 quality control solutions: Hematocrit and Metabolite QUALICHECK Level 1, S7170 (K150226), Hematocrit and Metabolite QUALICHECK Level 2, S7180 (K150226), Range+ QUALICHECK Level 1, S7930 (K130236), Range+ QUALICHECK Level 2, S7940 (K130236), Range+ QUALICHECK Level 3, S7950 (K130236). These quality control solutions have been 510(k) cleared (K150226 and K130236) with an intended use which did not include calibration verification of this kit consists solely in repackaging and relabeling of the already cleared products. Each kit consists of 4 ampoules of each constituent quality control solution. One ampoule contains 2 mL of solution. The Hematocrit and Metabolite QUALICHECK quality control solutions are aqueous solutions containing organic buffer, acid, salts, metabolites, and a preservative. The Range+ QUALICHECK quality control solutions are aqueous solutions containing biological buffers, salts, glucose, lactate, dyes and a preservative, and are equilibrated with carbon dioxide and oxygen.

VK-4 Verification Kit is a calibration verification kit consisting of the following 4 quality control solutions: Qualicheck 5+ Level 1, S7730 (K980135), Qualicheck 5+ Level 2, S7740 (K980135), Qualicheck 5+ Level 3, S7750 (K980135), Qualicheck 5+ Level 4, S7760 (K980135). These quality control solutions have been 510(k) cleared (K980135) with an intended use which did not include calibration verification. Production of this kit consists solely in repackaging and relabeling of the already cleared products. Each kit consists of 4 ampoules of each constituent quality control solution. One ampoule contains 2 mL of solution. The quality control solutions are agueous solutions containing biological buffers, salts, qlucose, lactate, dyes and a preservative, and are equilibrated with carbon dioxide and oxygen.

VK-R5 Verification Kit is a calibration kit consisting of the following 4 quality control solutions: Range+ QUALICHECK Level 1, S7930 (K130236), Range+ QUALICHECK Level 2, S7940 (K130236), Range+ QUALICHECK Level 3, S7950 (K130236), Qualicheck 5+, Level 3, S7750, (K980135). These quality control solutions have been 510(k) cleared (K130236 and K980135) with an intended use which did not include calibration verification of this kit consists solely in repackaging and relabeling of the already cleared products. Each kit consists of 4 ampoules of each constituent quality control solution. One ampoule contains 2 mL of solution. The quality control solutions are agueous solutions containing biological buffers, salts, qlucose, lactate, dyes and a preservative, and are equilibrated with carbon dioxide and oxygen.

VK-R7 Verification Kit is a calibration verification kit consisting of the following 4 quality control solutions: Range+ QUALICHECK Level 1, S7930 (K130236), Range+ QUALICHECK Level 2, S7940 (K130236), Range+ QUALICHECK Level 3, S7950 (K130236), High Metabolite QUALICHECK Level 1, S7570 (K130415). These quality control solutions have been 510(k) cleared (K130236 and K130415) with an intended use which did not include calibration verification of this kit consists solely in repackaging and relabeling of the already cleared products. Each kit consists of 4 ampoules of each constituent quality control solution. One ampoule contains 2 mL of solution. The Range+ QUALICHECK quality control solutions are aqueous solutions containing biological buffers, salts, glucose, lactate, dyes and a preservative, and are equilibrated with carbon dioxide and oxygen. The High Metabolite QUALICHECK quality control solutions are aqueous solutions containing biological buffers, salts, metabolites and a preservative.

VK-Crea Verification Kit is a calibration verification kit consisting of the following 4 quality control solutions: AutoCheck6+ Level 1, S7835 (K051928), AutoCheck6+ Level 2, S7845 (K051928), AutoCheck6+ Level 3, S7855 (K051928), Cleaning Met II Solution, S8377 (K051968). These quality control solutions have been 510(k) cleared (K051928) and (K051968) with an intended use which did not include calibration verification of this kit consists solely in repackaging and relabeling of the already cleared products. Each kit consists of 4 ampoules of each level of AutoCheck6+ and one bottle of Cleaning Met II Solution. Each AutoCheck6+ ampoule contains 0.7 mL solution. The Cleaning Met II Solution contains 100 mL solution. The quality control solutions are aqueous solutions containing biological buffers, salts, metabolites, enzyme and a preservative. The AutoCheck6+ solutions also contain dyes and are equilibrated with carbon dioxide and oxygen.

AI/ML Overview

The provided document describes the clearance of several "Verification Kits" as calibration verification materials for in vitro diagnostic use. It establishes substantial equivalence by comparing the new kits to a predicate device (Validate GC1, GC2, GC3, and GC4 Calibration Verification/Linearity Test Sets).

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for the performance of the new Verification Kits. Instead, it leverages the previous 510(k) clearances of the individual components within these kits and argues that because the new kits are essentially repackaged and relabeled versions of already cleared products, their performance characteristics are maintained. The acceptance criteria essentially revolve around demonstrating that the new kits are substantially equivalent to the predicate device and that their performance (stability, storage, traceability, and value assignment) is consistent with the cleared individual components.

Acceptance Criteria (Implied)	Reported Device Performance (as stated in document)
Substantial Equivalence:

Intended Use
Fundamental Scientific Technology
Features
Characteristics | VK-3, VK-4, VK-R5, VK-R7, VK-Crea Verification Kits:
Intended Use: "For in vitro diagnostic use. ... assayed quality control systems for calibration verification for the parameters and the analyzers listed in the insert specifying the control ranges." (Similar to predicate)
Fundamental Scientific Technology: All kits are liquid, aqueous solutions, similar to predicate.
Features: All kits are multi-analyte controls.
Characteristics: Product Code (JJY), Matrix (Aqueous primarily, predicate has human serum and aqueous), Traceability (IUPAC pH scale, NIST SRM, IFCC, SIGMA, primary analytical standards). Measurands vary but are within the scope of multi-analyte controls. |
| Stability (Shelf Life):
Maintained from individual components | VK-3, VK-4, VK-R5, VK-R7, VK-Crea Verification Kits:
Shelf life: 24 months (or 12 months for VK-Crea) as maximum, depending on oldest component. (Predicate: 12 months for all). Document states stability is "documented by reference to K150226, K130236, K980135, K130415, K051928 and K051968" (previous clearances of individual components). |
| Stability (Open Vial):
Maintained from individual components | VK-3, VK-4, VK-R5, VK-R7, VK-Crea Verification Kits:
Open vial stability: N/A, "shall be used immediately." (Predicate: 12 months). The document states that the open vial stability for the new kits is "not affected by the repackaging" implying that the lack of open vial stability is part of the established performance. |
| Storage Conditions:
Maintained from individual components | VK-3, VK-R5, VK-R7, VK-Crea: 2 °C – 8 °C.
VK-4: 2 °C – 25 °C. (Predicate: 2 °C – 8 °C). Document states storage conditions are "for the most temperature sensitive component" and "documented by reference to K150226, K980135, K130415, K051928 and K051968". |
| Traceability:
Maintained from individual components | VK-3, VK-4, VK-R5, VK-R7, VK-Crea Verification Kits:
Traceable to "established international references as defined for the individual components and are unchanged." (Predicate: NIST SRM, primary analytical standards). Document states "documented by reference to K150226, K130236, K980135, K130415, K051928 and K051968". |
| Value Assignment:
Maintained from individual components | VK-3, VK-4, VK-R5, VK-R7, VK-Crea Verification Kits:
"Assigned values for each of the parameters are transferred unchanged from the labeling of the individual components to the Verification Kits." Document states "documented by reference to K150226, K130236, K980135, K130415, K051928 and K051968". |

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

The document does not describe a traditional "test set" in the context of device performance in the same way one would for a new clinical diagnostic algorithm. This submission is for an in vitro diagnostic control material that is a repackaging of existing, cleared components.

Sample Size for Test Set: Not applicable in the conventional sense. The "test" for the new kits primarily involves demonstrating that repackaging does not alter the established performance of the individual components. The performance data for the individual components would have been provided in their respective 510(k) submissions (K150226, K130236, K980135, K130415, K051928, K051968). The current submission relies on references to these previous clearances.
Data Provenance: The data provenance for the underlying performance of the individual components would be detailed in their original 510(k) submissions. This document implies retrospective reliance on previously cleared data. It does not mention any new prospective studies specific to the repackaged kits, beyond demonstrating that the new packaging/labeling process itself doesn't degrade the product.

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

This is not applicable. The "ground truth" for calibration verification kits refers to the accurately assigned values for the analytes. This is established through rigorous analytical measurement and traceability to international standards (e.g., NIST SRM, IUPAC pH scale, IFCC, SIGMA), not by expert consensus in clinical interpretation.

4. Adjudication Method for the Test Set

This is not applicable for a calibration verification kit. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where human experts are interpreting results and discrepancies need to be resolved. The "truth" for these kits is analytical.

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 is not applicable. MRMC studies are used for evaluating the performance of imaging or other diagnostic devices where human interpretation is involved, often in comparison to an AI algorithm. The devices in question are calibration verification kits, which are chemical analytical controls. There is no human "reader" or AI involved in their direct function.

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

This is not applicable. The devices are physical chemical control solutions, not software algorithms.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for these calibration verification kits is analytical traceability, established through:

Reference Materials: Traceability to NIST (National Institute of Standards and Technology) Standard Reference Materials (SRM).
International Standards: Traceability to IUPAC pH scale, IFCC (International Federation of Clinical Chemistry and Laboratory Medicine) standards, and SIGMA standards.
Primary Analytical Standards: The document mentions "primary analytical standards" for the predicate device, implying similar methodologies for the SE device's components.

These methods involve precise chemical and physical measurements to assign accurate values to the analytes in the control solutions.

8. The Sample Size for the Training Set

This is not applicable. These are physical chemical control materials, not AI algorithms or models that require training data.

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

This is not applicable, as there is no "training set." The ground truth for the performance parameters of the individual components of these kits was established through analytical methods and traceability as described in point 7, during their original 510(k) clearances.

Ask a Question

Ask a specific question about this device

K Number

K150300

Device Name

Manufacturer

Bio-Rad Laboratories

Date Cleared

2015-12-11

(308 days)

Product Code

JJY,REG

Regulation Number

Type

Panel

VALIDATE Anemia Calibration Verification/ Linearity Test Kit

Reference & Predicate Devices

K050537

Intended Use

Liquichek Cardiac Markers Plus Control LT is intended for use as a quality control serum to monitor the precision of laboratory testing procedures listed in the package insert.

The following analytes are listed in the package insert: B-type Natriuretic Peptide (BNP) CK-MB Isoenzyme C-Reactive Protein (CRP) Creatine Kinase (CK) D-dimer Digitoxin Homocysteine Myeloperoxidase (MPO) Myoglobin N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) Troponin I Troponin T

Device Description

Liquichek Cardiac Markers Plus Control LT is prepared from human serum with added constituents of human and animal origin, stabilizers and preservatives. This product is provided in liquid form for convenience.

Each human donor unit used to manufacture this control was tested by FDA accepted methods and found non-reactive for Hepatitis B Surface Antigen (HBsAg), antibody to Hepatitis C (HCV) and antibody to HIV-1/HIV-2.

AI/ML Overview

This document is a 510(k) premarket notification summary for a quality control material, not an AI/ML medical device. Therefore, many of the requested categories for AI/ML device studies are not applicable.

However, I can extract information relevant to the 'acceptance criteria' and 'study' framework as much as possible for this type of device, focusing on stability studies which are analogous to performance studies for these materials.

1. Table of Acceptance Criteria and Reported Device Performance

For a quality control material, "acceptance criteria" often refer to the established stability periods under various conditions, which are then met by "reported device performance" through stability studies.

Acceptance Criteria (Stability Goal)	Reported Device Performance (Stability Achieved)
Thawed and Opened Stability:
NT-proBNP: 15 days at 2 to 8°C	15 days at 2 to 8°C
Troponin I: 10 days at 2 to 8°C	10 days at 2 to 8°C
BNP: 8 days at 2 to 8°C	8 days at 2 to 8°C
Troponin T: 4 days at 2 to 8°C	4 days at 2 to 8°C
All other analytes: 20 days at 2 to 8°C	20 days at 2 to 8°C
Frozen Aliquot Stability:
30 days at -20 to -70°C	30 days at -20 to -70°C
Shelf Life Stability:
Until expiration (goal)	36 months at -20 to -70°C

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

Test Set Sample Size: The document does not specify exact sample sizes for the stability studies (e.g., number of lots, replicates per time point). It mentions "replicate analyses" were used to derive mean values and ranges for value assignment and that "a representative sampling of this lot of control" was used for testing.
Data Provenance: The studies were performed by the manufacturer, Bio-Rad Laboratories, and/or independent laboratories. The document does not specify the country of origin of the data, but the manufacturer is based in Irvine, California, USA. The studies are prospective in nature, as they are real-time and accelerated stability studies conducted on the device itself.

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

This question is not applicable. For a quality control material, analytical values (the "ground truth" equivalent for performance testing) are established through "value assignment" processes using validated laboratory methods and instruments, not by expert consensus from individuals like radiologists. The document states: "The tests listed were performed by the manufacturer and/or independent laboratories using manufacturer supported reagents."

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods (like 2+1, 3+1) are typically used for establishing ground truth in clinical image interpretation or clinical decision-making studies, not for the analytical performance of laboratory quality control materials.

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 relevant for AI-assisted diagnostic tools that involve human interpretation of medical images or data. The device here is a quality control material intended to monitor the precision of laboratory testing procedures.

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

This question is not applicable. This device is a quality control material, not an algorithm or AI system. Its "performance" is its stability and its ability to provide target values for laboratory instruments.

7. The Type of Ground Truth Used

For the value assignment (which serves as the "ground truth" for expected analytic values), laboratory results from specific analytical methods and instruments are used. The document states, "The mean values and the corresponding ±3SD ranges printed in this insert were derived from replicate analyses and are specific for each lot of product. The tests listed were performed by the manufacturer and/or independent laboratories using manufacturer supported reagents and a representative sampling of this lot of control." This is essentially analytical reference values established by validated laboratory testing.

8. The Sample Size for the Training Set

This question is not applicable. This device is a quality control material and does not involve AI/ML algorithms that require training sets.

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

This question is not applicable, as there is no training set for this device.

Ask a Question

Ask a specific question about this device

K Number

K142964

Device Name

Manufacturer

MAINE STANDARDS COMPANY, LLC

Date Cleared

2015-04-30

(198 days)

Product Code

Regulation Number

Type

Panel

Liquichek Maternal Serum II Control

Reference & Predicate Devices

k133550

Intended Use

VALIDATE® Anemia Calibration Verification/Linearity Test Kit solutions are intended for in vitro diagnostic use in the quantitative determination of linearity, calibration and verification of reportable range for the following analytes: Ferritin Set: ferritin (FERR), Vitamin B12(VITB) and folate (FOL), on automated instrument systems. The product is intended for use with quantitative assays on the indicated analyzers specified in the labeling.

Device Description

Each VALIDATE® Anemia Calibration Verification / Linearity Test Kit contains two analyte sets of purified chemicals in a human serum base. The kit includes a Ferritin set containing five liguid levels, 3.0mL each, and a Vitamin B12/Folate set containing five liquid levels, 4.0 mL each. The sets are provided to establish the relationship between theoretical and actual performance of the included analytes: Ferritin, Vitamin B12 and Folate. Material of human origin used in the manufacture of this test kit was tested at the donor level using FDA approved methods and was found to be non-reactive for HBsAG and to antibodies to HCV and HIV-1/2.

AI/ML Overview

The provided text describes the performance data for the VALIDATE® Anemia Calibration Verification/Linearity Test Kit. This product is a quality control material, not a device that directly measures a patient's condition or relies on AI. Therefore, the common acceptance criteria and study designs typically associated with AI-powered medical devices (such as sensitivity, specificity, MRMC studies, and ground truth established by experts for a test set) are not applicable here.

Instead, the acceptance criteria and study detailed focus on the technical performance of the calibration verification/linearity kit itself, to ensure it provides accurate and linear results when used with automated instrument systems.

Here's an analysis based on the information provided, reinterpreting some categories to fit the context of a calibration verification kit:

1. Table of Acceptance Criteria and Reported Device Performance:

Feature/Test	Acceptance Criteria	Reported Device Performance
Value Assignment	Levels 1-5 must meet specified Ferritin, Vitamin B12, and Folate targets. (Ranges determined by upper/lower detection limits; intermediate levels calculated based on equal dilutions following EP6-A guidelines).	All stated recovery values met internal pre-determined acceptance criteria.
Recovery Targets (Low/High Levels)	90 to 110% of DOM value for product levels 2-5 during stability testing.	All product levels tested within the 90 to 110% of control acceptance criteria limits.
Freeze/Thaw Stability	Within 90 to 110% of control acceptance criteria limits.	Tested within the 90 to 110% of control acceptance criteria limits after 6 freeze/thaw events.
Shelf Life	Maintain stability for claim duration.	Set at 12 months based on real-time open vial studies (worst-case scenario).
Product Linearity	Demonstrated linearity on specified automated systems.	Product linearity performance was demonstrated for both automated systems (Roche® Cobas 6000 Chemistry Analyzer and Beckman-Coulter® Access II Immunochemistry Analyzer).

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

Sample Size: The number of individual test kit units or measurements used for "value assignment" and "stability" testing is not explicitly stated as a numerical sample size. It refers to testing on "Levels 1 through 5" of the kit. For stability, testing was done at "date of manufacture (DOM), followed by testing at specific intervals post manufacture" and "one month post-expiration." Freeze/thaw stability was assessed for "four (4) freeze/thaw events claim" and tested after "6 freeze/thaw events."
Data Provenance: The studies were conducted internally by Maine Standards Company LLC. The text does not specify the country of origin of the raw data, but the company is based in the US. The studies appear to be prospective to validate the manufacturing and stability of the product.

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

This question is not directly applicable in the typical sense of expert review for medical imaging or diagnostic algorithms. For this device, the "ground truth" or reference values are established by the manufacturing process itself:

"Levels 1 and 5 are prepared independently by the addition of Ferritin, Vitamin B12 and Folate to a human serum base."
"Intermediate 2, 3, and 4 are subsequently prepared from Levels 1 and 5 by equal part dilutions following EP6-A guidelines."
The actual "ground truth" for the performance evaluation is the predetermined theoretical concentrations that the calibration verification kit levels should represent based on their formulation. The device's performance is then measured by how well instruments recover these known concentrations and demonstrate linearity.

There's no mention of external experts adjudicating results for the test set.

4. Adjudication Method for the Test Set:

Not applicable in the conventional sense. The test results are compared against internal, pre-determined acceptance criteria based on the known composition and expected behavior of the calibration verification material, and adherence to CLSI EP6-A guidelines.

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 intended for instrument calibration and linearity verification, not a diagnostic device that assists human readers.

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

Not applicable. This device is used by automated analytical instruments (Roche Cobas, Beckman Access) to verify their performance. Its "standalone" performance means its inherent accuracy in representing known concentrations, which is what the "Value Assignment" and "Linearity" sections address. The analytical instruments are the "algorithm" in this context, and this device checks their accuracy.

7. The Type of Ground Truth Used:

The ground truth is based on:

Known concentrations: The product is manufactured with specific, known concentrations of analytes (Ferritin, B12, Folate) at Levels 1 and 5.
Dilution principles: Intermediate levels (2, 3, 4) are prepared by precise dilutions from Levels 1 and 5, following CLSI EP6-A guidelines, establishing their theoretical concentrations.
Reference Standards: The product is described as "traceable to a reference standard based on the automated instrument platform it is used on." This implies a higher-level standard (e.g., NIST traceable or other internationally recognized standards) against which the instrument's calibrators are established, and by extension, this product helps verify that performance.

8. The Sample Size for the Training Set:

Not applicable. This is not a machine learning or AI device that requires a "training set." The product is a manufactured reagent with a defined chemical composition.

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

Not applicable, as there is no "training set" for this type of device.

Ask a Question

Ask a specific question about this device

K Number

K143379

Device Name

Manufacturer

Bio-Rad Laboratories

Date Cleared

2015-03-13

(108 days)

Product Code

JJY,REG

Regulation Number

Type

Panel

Audit MicroControls Linearity FD Tumor Markers II

Reference & Predicate Devices

K984594

Intended Use

Liquichek Maternal Serum II Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.

Device Description

Liquichek Maternal Serum II Control is prepared from defibrinated human plasma with added constituents of human origin, chemicals, stabilizers, and preservatives. The control is provided in liquid form for convenience.

AI/ML Overview

1. Acceptance Criteria and Reported Device Performance

The provided document is a 510(k) premarket notification for a Class I quality control material. For such devices, the primary "acceptance criteria" relate to demonstrating substantial equivalence to a legally marketed predicate device rather than specific clinical performance metrics like sensitivity or specificity.

The acceptance criteria for this device, the Liquichek Maternal Serum II Control, were primarily focused on demonstrating its suitability as an assayed quality control serum by comparing its characteristics and performance to a predicate device, the Lyphochek Maternal Serum Control (K984594). The key performance aspects evaluated were:

Intended Use: The new device must have the same intended use as the predicate.
Base Matrix: The fundamental composition should be comparable.
Stability: The device must demonstrate adequate stability (thawed, opened, and shelf-life) to ensure its utility as a control material.
Analytes: The device should contain the analytes relevant to its intended use and listed on the package insert, similar to or expanded from the predicate.

Table 1: Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Characteristic	Predicate Device (Lyphochek Maternal Serum Control, K984594)	New Device (Liquichek Maternal Serum II Control)	Outcome/Performance
Intended Use	Assayed quality control serum to monitor precision for listed analytes.	Assayed quality control serum to monitor precision for listed analytes.	Same Intended Use
Base Matrix	Defibrinated Human Plasma	Defibrinated Human Plasma	Same
Form	Lyophilized	Liquid	Difference (Liquid is a manufacturing difference, not a failure of acceptance)
Fill Size	5 mL	2.5 mL	Difference (Manufacturing difference)
Thawed and Unopened Stability	No claims made	40 days at 2 to 8°C	Established
Thawed and Opened Stability	10 days at 2 to 8°C / After Reconstitution	30 days at 2 to 8°C	Improved (Extended stability)
Shelf Storage & Stability	2 to 8°C until expiration date	-20 to -70°C until expiration date (40 months)	Difference (Different storage conditions/duration, but established)
Analytes	AFP, hCG, Estriol, Free	AFP, hCG, Unconjugated Estriol, Inhibin A	Expanded (New device includes Inhibin A)
Value Assignment	Established by replicate analyses with manufacturer/independent labs.	Established by replicate analyses with manufacturer/independent labs.	Same methodology

Study Proving Device Meets Acceptance Criteria

The study described is a comparison study to demonstrate substantial equivalence to the predicate device, along with stability studies to establish the shelf life and in-use stability of the new control material.

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 numerical sample size for the test set in terms of cases or individual control units used for the comparison or stability studies. It states that mean values and ranges were derived from "replicate analyses," and "a representative sampling of this lot of product" was used. For stability, "real time stability studies" and "accelerated stability studies" were performed.
Data Provenance: The studies were performed internally by Bio-Rad Laboratories or by "independent laboratories." The country of origin of the data is implied to be related to Bio-Rad Laboratories' operations, which is based in Irvine, California, USA. The studies are prospective in nature, as they are conducted on the newly manufactured device to establish its performance and stability claims.

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

Not Applicable. This is a quality control material, not a diagnostic medical device that interprets patient data. Therefore, there is no "ground truth" in the clinical sense established by human experts. The "truth" for this device relates to its known analyte concentrations and its stability characteristics. The "value assignment" for the analytes is performed through analytical testing by the manufacturer and/or independent laboratories, not by expert consensus on clinical findings.

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

Not Applicable. As explained above, this device does not involve human interpretation of clinical data that would require an adjudication method. The performance is assessed through analytical measurements and comparison to predefined specifications (i.e., stability protocols, value assignment procedures).

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 and not an AI-powered diagnostic device. Therefore, MRMC studies are not relevant to its evaluation.

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

Not Applicable. This device is a biochemical control material, not an algorithm or software. Its performance is inherent to its chemical composition and stability.

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

The "ground truth" in the context of a quality control material refers to the assigned target values and acceptable ranges for each analyte within the control. This "truth" is established through replicate quantitative analytical measurements using validated methods by the manufacturer and/or independent laboratories, rather than expert consensus on clinical data or pathology. The stability ground truth is established through real-time and accelerated stability studies monitoring analyte concentrations over time under specified storage conditions.

8. The sample size for the training set

Not Applicable. As a quality control material, this device does not involve machine learning or AI, and therefore, no "training set" is used. Its development and characterization rely on established laboratory manufacturing and analytical testing procedures.

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

Not Applicable. See point 8.

Ask a Question

Ask a specific question about this device

K Number

K143573

Device Name

Manufacturer

AALTO SCIENTIFIC LTD.

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.

Ask a Question

Ask a specific question about this device

K Number

K140971

Device Name

LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3.

Manufacturer

RANDOX LABORATORIES LIMITED

Date Cleared

2014-12-08

(236 days)

Product Code

Regulation Number

Type

Panel

Audit MicroControls Linearity LQ Special Diabetes

Reference & Predicate Devices

K130162

Intended Use

The Liquid Assayed Chemistry Control Premium Plus Levels 1, 2 and 3 are assayed quality control materials intended for in vitro diagnostic use in the quality control of diagnostic assays. This material can be used to monitor the accuracy or reproducibility of analytes listed in the package insert. This device is for prescription use only.

Device Description

The Liquid Assayed Chemistry Control Premium Plus is human liquid sera to which purified biochemical material, chemicals, drugs, preservatives and stabilizers have been added. The material is supplied at levels 1, 2 and 3. Each 5 ml vial of liquid serum is stored at -20°C to -70°C. Each level is supplied in a 12 by 5ml vials.

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria.

The document is a 510(k) premarket notification for a medical device called "Liquid Assayed Chemistry Control Premium Plus Level 1, 2 and 3". It describes the device, its intended use, compares it to a predicate device, and includes summaries of stability studies (thawed open vial stability and shelf-life study) and value assignment.

Here's what I can extract, focusing on "acceptance criteria" as applied in the context of the control material stability studies:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance (Summary)
Thawed Open Vial Stability	All acceptance criteria for all analytes	All acceptance criteria were met for all analytes.
Shelf-life Study (Real Time Testing)	All acceptance criteria for all analytes	All acceptance criteria were met for all analytes.

Important Note: The document states that "All acceptance criteria were met for all the analytes" for both stability studies, but it does not explicitly list the specific numerical or qualitative acceptance criteria themselves. It only mentions that the percentage deviation was calculated for the shelf-life study.

Regarding the other requested information, there is no data in the provided text:

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

The document does not specify the sample size for the stability studies or value assignment process.
It does not mention the country of origin of the data or whether the studies were retrospective or prospective.

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 information is not applicable as the device is a quality control material, not an AI or diagnostic imaging device that requires interpretation by experts for ground truth establishment in a test set.
For value assignment, it mentions "a number of external laboratories" and "in-house testing," but does not specify the number or qualifications of personnel involved.

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

This information is not applicable. Adjudication methods are typically used in studies involving human interpretation or subjective data, which is not the primary focus of testing a quality control material.

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 information 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 information is not applicable. The device is a quality control material, not an algorithm.

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

For the stability studies, the "ground truth" or reference is assumed to be the established values or expected performance of the control material under specific conditions, compared to its performance over time. The document mentions "statistical analysis including the mean, SD and % CV were calculated" and that "an assigned value is calculated from the target mean specific value." This implies a reference standard derived from analytical measurements rather than expert consensus or pathology.

8. The sample size for the training set

This information is not applicable as the device is a quality control material, not an AI model requiring a training set.

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

This information is not applicable.

Ask a Question

Ask a specific question about this device

K Number

K142978

Device Name

Manufacturer

AALTO SCIENTIFIC LTD.

Date Cleared

2014-11-20

(36 days)

Product Code

Regulation Number

Type

Panel