Audit MicroControls Linearity FD Tumor Markers II

K143573 · Aalto Scientific, Ltd. · JJY · Jan 16, 2015 · Clinical Chemistry

Device Facts

• Record ID: K143573
• Device Name: Audit MicroControls Linearity FD Tumor Markers II
• Applicant: Aalto Scientific, Ltd.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Jan 16, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

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 verification, 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 Story

Audit® MicroControls™ Linearity FD Tumor Markers II is an in-vitro diagnostic quality control material; consists of two sets of five levels (A-E) of freeze-dried human/bovine serum-based material. Used by clinical laboratory professionals to verify linearity, calibration, and reportable range of tumor marker assays (AFP, CEA, PSA, CA-125, CA19-9, CA27-29, fPSA, CA15-3). Device functions as a reference material; samples are processed on clinical chemistry analyzers (e.g., Siemens Advia Centaur, Abbott Architect i1000SR). Output is a measured concentration value compared against established target ranges (±20%). Helps ensure accuracy and reliability of patient test results; aids in identifying potential instrument or reagent performance issues.

Clinical Evidence

Bench testing only. Stability studies (accelerated and real-time) confirmed shelf life of 2 years at 2-8°C and 14-day reconstituted stability at 2-8°C. Value assignment performed on Siemens Advia Centaur and Abbott Architect i1000SR platforms using multiple measurements to establish target concentrations and ranges (±20%). No clinical patient data included.

Technological Characteristics

Freeze-dried human and bovine serum-based matrix. Five-level linearity set. Storage 2-8°C. Analyte-specific value assignment via clinical chemistry analyzers. Non-sterile. No software or electronic components.

Indications for Use

Indicated for use as an assayed quality control material to simulate human patient samples for determining linearity, calibration verification, and reportable range verification of specific tumor marker analytes in clinical laboratory settings.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures in profile.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 16, 2015

Aalto Scientific Ltd. c/o Mr. Robert Burda Regulatory Affairs Manager 1959 Kellogg Avenue Carlsbad, CA 92008

Re: k143573

Trade/Device Name: Audit® MicroControls™ FD Linearity Tumor Markers II Regulation Number: 21 §CFR 862.1660 Regulation Name: Ouality Control Material (assayed and unassayed) Regulatory Class: Class I, Reserved Product Code: JJY Dated: December 12, 2014 Received: December 17, 2014

Dear Mr. Burda:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Leonthena R. Carrington -A

Leonthena Carrington, MS, MBA, MT (ASCP) Director (Acting) Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K143573

Device Name

Audit® MicroControls™ Linearity FD Tumor Markers II

Indications for Use (Describe)

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.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 100%;"> <input checked="true" type="checkbox"/> </span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size: 100%;"> <input type="checkbox"/> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# Aalto Scientific Ltd.

# 510(k) Summary

# 510(k) Summary - Audit® MicroControls™ Linearity FD Tumor Markers II

Introduction: According to the requirements of 21 CFR 807.92, the following information provides sufficient details to understand the basis for determination of substantial equivalence.

#### The assigned 510(k) number: k143573

#### A. Submitter

Aalto Scientific, Ltd. 1959 Kellogg Ave. Carlsbad, CA 92008 Telephone: [phone] Fax: [phone]

Contact Person

Robert Burda Regulatory Affairs Manager Telephone: [phone] ext. 134 Email: [e-mail]

Date Prepared: January16, 2014

## B. Device Identification

| Product Trade Name: | Audit® MicroControls™ Linearity FD Tumor<br>Markers II |
|------------------------|--------------------------------------------------------------|
| Common Name: | Multi-Analyte Controls, All Kinds (Assayed and<br>Unassayed) |
| Review Panel: | Clinical Chemistry |
| Device Classification: | Class I, Reserved |
| Product Code: | JJY |
| Regulation Number: | 21CFR862.1660 |

# C. Device to Which Substantial Equivalence is Claimed

K082717 Audit® MicroCV™ Tumor Markers Linearity Set

## D. Intended Use

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The Linearity FD Tumor Markers II is an assayed quality control material intended to simulate human patient samples for use in determining linearity, calibration verification, 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.

| Characteristics | Audit® MicroControls™<br>Linearity FD Tumor Markers<br>II<br>(New Device) | Audit® MicroCV™ Tumor<br>Markers Linearity Set<br>(Predicate Device,<br>K082717) |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Linearity FD Tumor<br>Markers II is an assayed<br>quality control material<br>intended to simulate human<br>patient samples for use in<br>determining linearity,<br>calibration verification, and<br>the verification of reportable<br>range for the following<br>analytes: Alpha fetoprotein<br>(AFP), Carcinoembryonic<br>antigen (CEA), Prostate-<br>specific antigen-total (PSA),<br>Carbonic Anhydrase-125<br>(CA-125), Carbonic<br>Anhydrase 19-9 (CA19-9),<br>Carbonic Anhydrase 27-29<br>(CA27-29)/(BR), free-PSA<br>(fPSA), and Carbonic<br>Anhydrase 15-3 (CA15-3).<br><br>The Linearity FD Tumor<br>Markers II is for In Vitro<br>Diagnostic use only. | The Audit™ MicroCV™<br>Tumor Markers Linearity<br>Set consists of five levels in<br>Human based serum. Each<br>level contains the following<br>analytes: Alpha fetoprotein<br>(AFP), Carcinoembryonic<br>antigen (CEA), CA-125,<br>CA15-3, Prostate specific<br>antigen-free (free PSA),<br>total PSA. The five levels<br>demonstrate a linear<br>relationship to each other<br>for their respective analytes,<br>reagents, and instruments.<br>This product may be used<br>for proficiency testing in<br>interlaboratory surveys. |
| Number of<br>Levels per Set | 5 | 5 |
| Contents | 5x1ml (two sets) | 5x1ml (one set) |
| Matrix | Human Based Serum and<br>bovine based serum | Human Based Serum |
| Type of | Clinical Chemistry | Clinical Chemistry |

# E. Technical Characteristics Compared to Predicate Device

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| Analytes | | |
|-----------------------------------|-----------------------------------------------------------------|----------------------------------------------|
| Form | Freeze Dried | Freeze Dried |
| Storage | 2-8°C | 2-8°C |
| Reconstituted<br>Stability | fPSA-7 days at 2-8°C,<br>Remaining analytes-14 days<br>at 2-8°C | 7 days at 2-8°C |
| Sterile | No | No |
| Analytes | AFP, CEA, CA-125, CA15-3,<br>fPSA, total PSA, CA19-9,<br>CA27-9 | AFP, CEA, CA-125,<br>CA15-3, fPSA, total PSA |
| Number of<br>Analytes per<br>Vial | 6 (Set 1) and 2 (Set 2) | 6 |

#### F. 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.

#### G. Value Assignment/Linearity

Analyte value assignment for Level A through Level E was performed on Siemens Advia Centaur for the analytes: AFP, CEA, PSA, CA125, CA27-29 (BR), and CA15-3 using the corresponding reagent. Analyte value assignment for the analytes: CA19-9. and free-PSA were performed on Abbott Architect i1000SR using the corresponding reagent. Each analyte was measured multiple times. The mean value of each analyte was used to establish target concentration value at each level. All supporting data is retained on file at Aalto Scientific, Ltd.

## AMR

- AFP: 1.3-1000 ng/ml CEA: 0.5-100ng/ml PSA: 0.01-1000 ng/ml CA125: 2-600 U CA27-29 (BR): 3.5-450 U/ml CA15-3: 0.5-200 U/ml CA19-9: 1.2-1200 U/ml fPSA: 0.008-30 ng/ml

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## H. Summary of Performance Data

Stability studies have been performed to determine the reconstituted vial stability and shelf life for the Audit® MicroControls™ Linearity FD Tumor Markers II.

#### Shelf Life-Accelerated Stability

Accelerated stability studies were conducted to establish the shelf life stability claims. All supporting data is retained on file at Aalto Scientific, Ltd. Acceptance criteria were met to support the product claims as follows:

Shelf Life: 2 years, when stored unopened at 2-8° C.

#### Shelf Life-Real Time Stability

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. The analyte values from the real time vials are compared to the Day0 vials (both tested in duplicate). The 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. All supporting data is retained on file at Aalto Scientific, Ltd.

Note: Real time studies are ongoing to support the shelf life of this product.

#### Reconstituted Vial-Accelerated Stability+Real Time Stability

Real time stability studies were conducted at the end of accelerated stability studies to establish the reconstituted vial stability claims. All supporting data is retained on file at Aalto Scientific, Ltd. Acceptance criteria were met to support the product claims as follows:

Reconstituted Stability: Once a vial has been opened and reconstituted, the product will be stable for 14 days when stored tightly capped at 2-8° C.

## I. Expected Values

Value assignment of Audit® MicroControls™ Linearity FD Tumor Markers II have been performed to determine the expected values of the AFP, CEA, CA-125, CA15-3, fPSA, total PSA, CA19-9, CA27-9 analytes. Each analyte value assignment for Level A through Level E was performed on Siemens Advia Centaur using the corresponding reagents for AFP, CEA, PSA, CA125, CA27-29 (BR), and CA15-3. Each analyte value assignment for Level A through Level E was performed on Abbott Architect i1000SR using the corresponding reagent for CA19-9, and free-PSA. Each analyte was measured multiple times and the mean value of each analyte was used to establish target values at each level. The target ranges were calculated as +/-20% of the target mean values.

All supporting data is retained on file at Aalto Scientific, Ltd. Product claims are as follows:

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| AFP (ng/ml)/Siemens Advia Centaur | | | | | | | | | | |
|-----------------------------------|-----------------|-----------------|-----------------|-----------------|-----------------|-----------------|-----------------|-----------------|------------------|--|
| Level A | Level B | Level C | Level D | Level E | | | | | | |
| Target value | Target Range | Target value | Target Range | Target value | Target Range | Target value | Target Range | Target value | Target Range | |
| 8.2 | 6.5-9.8 | 264.5 | 211.6-317.4 | 515.4 | 412.3-618.5 | 785.1 | 628.1-942.1 | 1030.7 | 824.5-1236.8 | |
| CEA (ng/ml)/Siemens Advia Centaur | | | | | | | | | | |
| Level A | | Level B | | Level C | | Level D | | Level E | | |
| Target<br>value | Target<br>Range | Target<br>value | Target<br>Range | Target<br>value | Target<br>Range | Target<br>value | Target<br>Range | Target<br>value | Target<br>Range | |
| 3.01 | 2.41-3.62 | 29.36 | 23.49-<br>35.24 | 54.99 | 43.99-<br>65.99 | 76.86 | 61.49-<br>92.23 | 106.89 | 85.51-<br>128.27 | |

#### CEA (ng/ml)/Siemens Advia Centaur

| PSA (ng/ml)/Siemens Advia Centaur | | | | | | | | | |
|-----------------------------------|-----------------|-----------------|-----------------|-----------------|-----------------|-----------------|------------------|-----------------|------------------|
| Level A | Level B | Level C | Level D | Level E | | | | | |
| Target<br>value | Target<br>Range | Target<br>value | Target<br>Range | Target<br>value | Target<br>Range | Target<br>value | Target<br>Range | Target<br>value | Target<br>Range |
| 0.22 | 0.18-0.27 | 27.71 | 22.17-<br>33.25 | 57.12 | 45.70-<br>68.55 | 85.87 | 68.69-<br>103.04 | 115.07 | 92.05-<br>138.08 |

| CA125 (U/ml)/Siemens Advia Centaur | | | | | | | | | |
|------------------------------------|-----------------|-----------------|-----------------|-----------------|-----------------|-----------------|-----------------|-----------------|-----------------|
| Level A | | Level B | | Level C | | Level D | | Level E | |
| Target<br>value | Target<br>Range | Target<br>value | Target<br>Range | Target<br>value | Target<br>Range | Target<br>value | Target<br>Range | Target<br>value | Target<br>Range |
| 11.0 | 8.8-13.2 | 162.4 | 129.9-<br>194.8 | 302.3 | 241.8-<br>362.7 | 464.9 | 371.9-<br>557.9 | 620.1 | 496.1-<br>744.1 |

| CA27-29 (U/ml)/Siemens Advia Centaur | | | | | | | | | | |
|--------------------------------------|-----------------|-----------------|------------------|-----------------|-------------------|-----------------|-------------------|-----------------|-------------------|--|
| Level A | Level B | Level C | Level D | Level E | | | | | | |
| Target<br>value | Target<br>Range | Target<br>value | Target<br>Range | Target<br>value | Target<br>Range | Target<br>value | Target<br>Range | Target<br>value | Target<br>Range | |
| 11.61 | 9.29-<br>13.93 | 114.97 | 91.98-<br>137.96 | 222.32 | 177.85-<br>266.78 | 320.85 | 256.68-<br>385.02 | 429.50 | 343.60-<br>515.40 | |

| CA15-3 (U/ml)/Siemens Advia Centaur | | | | | | | | | |
|-------------------------------------|-----------------|-----------------|-----------------|-----------------|-----------------|-----------------|-----------------|-----------------|-----------------|
| Level A | Level B | Level C | Level D | Level E | | | | | |
| Target<br>value | Target<br>Range | Target<br>value | Target<br>Range | Target<br>value | Target<br>Range | Target<br>value | Target<br>Range | Target<br>value | Target<br>Range |
| 1.3 | 1.1-1.6 | 50.6 | 40.5-<br>60.8 | 100.9 | 80.7-<br>121.1 | 145.5 | 116.4-<br>174.6 | 200.1 | 160.0-<br>240.1 |

| CA19-9 (U/ml)/Abbott Architect i1000SR | | | | | | | | | | |
|----------------------------------------|--------------|-----------------|-------------------|-----------------|-------------------|-----------------|--------------------|-----------------|--------------------|--|
| Level A | | Level B | | | Level C | | Level D | | Level E | |
| Target<br>value | Target Range | Target<br>value | Target<br>Range | Target<br>value | Target<br>Range | Target<br>value | Target<br>Range | Target<br>value | Target<br>Range | |
| 7.01 | 5.60-8.41 | 295.48 | 236.38-<br>354.57 | 594.98 | 475.98-<br>713.98 | 878.37 | 702.70-<br>1054.04 | 1143.61 | 914.89-<br>1372.34 | |

####

| free-PSA (ng/ml)/Abbott Architect i1000SR | | | | | | | | | |
|-------------------------------------------|--------------|-----------------|--------------|-----------------|---------------|-----------------|---------------|-----------------|---------------|
| Level A | | Level B | | Level C | | Level D | | Level E | |
| Target<br>value | Target Range | Target<br>value | Target Range | Target<br>value | Target Range | Target<br>value | Target Range | Target<br>value | Target Range |
| 0.016 | 0.013-0.019 | 7.533 | 6.026-9.039 | 16.083 | 12.866-19.299 | 25.475 | 20.380-30.570 | 32.219 | 25.775-38.663 |

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# J. Traceability

Materials are obtained from internally qualified vendors and are subject to an internal quality control process. Raw material information is retained on file at Aalto Scientific, Ltd.

# K. Conclusions

Based upon the purpose of the device, the descriptions and labeling of the predicate device, the safety and efficacy, and the stability data generated, the product is substantially equivalent to the predicate device.