Audit MicroControls Linearity FD Unsaturated Iron Binding Capacity

K143026 · Aalto Scientific, Ltd. · JJX · Nov 21, 2014 · Clinical Chemistry

Device Facts

• Record ID: K143026
• Device Name: Audit MicroControls Linearity FD Unsaturated Iron Binding Capacity
• Applicant: Aalto Scientific, Ltd.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Nov 21, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

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 verification, 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 Story

Audit® MicroControls™ Linearity FD Unsaturated Iron Binding Capacity is a freeze-dried, human serum-based quality control material; provided in five levels (A-E). Used by clinical laboratory personnel to verify linearity, calibration, and reportable range of unsaturated iron binding capacity (UIBC) assays. Device does not perform analysis; rather, it serves as a reference material with assigned target values established via testing on a Hitachi P-Modular analyzer. Healthcare providers use the output (measured values compared to target ranges) to validate assay performance and ensure accurate patient sample testing. Benefits include improved confidence in clinical chemistry assay accuracy and reliability.

Clinical Evidence

No clinical data. Bench testing only. Stability studies (accelerated and real-time) established a 24-month shelf life at 2-8°C and 30-day reconstituted stability. Value assignment performed on Hitachi P-Modular analyzer with target ranges calculated as +/-15% of target mean values.

Technological Characteristics

Human serum-based matrix; freeze-dried form; 5 levels per set; 1ml per vial. Storage 2-8°C. Analyte: Unsaturated Iron Binding Capacity. Value assignment via Hitachi P-Modular analyzer. Non-sterile.

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 for unsaturated iron binding capacity assays 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)

{0}------------------------------------------------

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" written around it. Inside the circle is an emblem featuring a stylized caduceus with three intertwined snakes and a staff, representing health and medicine.

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

December 8, 2014

AALTO SCIENTIFIC LTD. ROBERT BURDA REGULATORY AFFAIRS MANAGER 1959 KELLOGG AVE. CARLSBAD CA 92008

Re: K143026

Trade/Device Name: Audit® MicroControls™ Linearity FD Unsaturated Iron Binding Capacity Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I, Reserved Product Code: JJX Dated: November 21, 2014 Received: November 21, 2014

Dear Mr. Robert Burda:

This letter corrects our substantially equivalent letter of November 21, 2014. 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

{1}------------------------------------------------

Page 2 – Mr. Burda

CFR Part 807); labeling Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Parts 801 and 809), 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/ResourcesforYou/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.

# Katherine Serrano -S

For : Courtney H. Lias, Ph.D.

Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K143026

Device Name

Audit® MicroControls™ Linearity FD Unsaturated Iron Binding Capacity

Indications for Use (Describe)

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.

| Type of Use (Select one or both, as applicable) |
|---------------------------------------------------------------------------------------------------------------|
| <div> <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> |
| <div> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# 510(k) Summary

## 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 of Summary Preparation

November 19, 2014

## B. Device Identification

| Product Trade Name: | Audit® MicroControls™ Linearity FD Unsaturated Iron Binding Capacity |
|------------------------|----------------------------------------------------------------------|
| Common Name: | Quality Control Material (Assayed and Unassayed) |
| Review Panel: | Clinical Chemistry and Clinical Toxicology Devices |
| Device Classification: | Class I, Reserved |
| Product Code: | JJX |
| Regulation Number: | 21CFR862.1660 |

## C. Device to Which Substantial Equivalence is Claimed

K130157 Audit® MicroCV™ Beta-Hydroxybutyric Acid Linearity Set

### D. 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 verification, and the verification of reportable range for unsaturated iron binding capacity.

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

{4}------------------------------------------------

| Characteristics | Audit® MicroControls™<br>Linearity FD Unsaturated Iron<br>Binding Capacity<br>(New Device) | Audit® MicroCV™ Beta-<br>Hydroxybutyric Acid<br>Linearity Set<br>(Predicate Device, K130157) |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Linearity FD Unsaturated<br>Iron Binding Capacity is an<br>assayed quality control material<br>intended to simulate human<br>patient samples for use in<br>determining linearity, calibration<br>verification, and the verification<br>of reportable range for<br>unsaturated iron binding<br>capacity.<br><br>Linearity FD Unsaturated Iron<br>Binding Capacity is for In Vitro<br>Diagnostic use only. | The Audit® MicroCV™ Beta-<br>Hydroxybutyric Acid<br>Linearity Set is an assayed<br>quality control material<br>consisting of five levels of<br>human based serum. Each<br>level contains Beta-<br>Hydroxybutyric Acid. These<br>five levels demonstrate a<br>linear relationship to each<br>other for Beta-<br>Hydroxybutyric Acid. It is<br>intended to simulate human<br>patient serum samples for<br>purpose of determining<br>linearity, calibration<br>verification and verification<br>of reportable range for Beta-<br>Hydroxybutyric Acid.<br><br>The product is intended for<br>use with quantitative assays<br>on the indicated analyzer<br>provided in the labeling and<br>may be used as quality control<br>material for Beta-<br>Hydroxybutyric Acid. When<br>used for quality control<br>purposes, it is recommended<br>that each laboratory establish<br>its own means and acceptable<br>ranges and use the values<br>provided only as guides. The<br>Audit® MicroCV™ Beta-<br>Hydroxybutyric Acid<br>Linearity Set should not be<br>used for calibration or<br>standardization of the Beta-<br>Hydroxybutyric Acid assay. |

# E. Technical Characteristics Compared to Predicate Device

{5}------------------------------------------------

| | | Hydroxybutyric Acid<br>Linearity Set is “For In Vitro<br>Diagnostic Use Only”. |
|--------------------------------|--------------------------------------|--------------------------------------------------------------------------------|
| Number of Levels<br>per Set | 5 | 5 |
| Contents | 5x1ml | 5x1ml |
| Matrix | Human Based Serum | Human Based Serum |
| Type of Analytes | Clinical Chemistry | Clinical Chemistry |
| Form | Freeze Dried | Liquid |
| Storage | 2-8°C | 2-8°C |
| Open Vial/Recon<br>Stability | 30 days at 2-8°C | 40 days at 2-8°C |
| Sterile | No | No |
| Analytes | Unsaturated Iron Binding<br>Capacity | Beta-hydroxybutyric acid |
| Number of<br>Analytes per Vial | 1 | 1 |

# F. 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.

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

Each analyte value assignment for Level A through Level E is performed on Hitachi P-Modular by using the corresponding reagent. Each analyte was measured multiple times. The unsaturated iron binding capacity (UIBC) was measured and the mean value of the iron binding capacity was used to establish target iron binding capacity values at each level.

AMR

Unsaturated Iron Binding Capacity: 10-500 µg/dL

## H. Summary of Performance Data

{6}------------------------------------------------

Stability studies have been performed to determine the reconstituted vial stability and shelf life for the Audit® MicroControls™ Linearity FD Unsaturated Iron Binding Capacity.

# 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: 24 months, 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 four 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 Day) 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 Vial Stability: Once a vial has been opened and reconstituted, the product will be stable for 30 days when stored tightly capped at 2-8° C.

# I. Expected Values/Value Assignment

Value assignment of Audit® MicroControls™ Linearity FD Unsaturated Iron Binding Capacity have been performed to determine the expected values of the unsaturated iron binding capacity. Each unsaturated iron binding capacity value assignment for Level A through Level E is performed on Hitachi P-Modular by using the corresponding reagent. The unsaturated iron binding capacity was measured multiple times and the mean value of unsaturated iron binding capacity was used to establish target values at each level. The target ranges were calculated as +/-15% of the target mean values.

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

{7}------------------------------------------------

| 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 |
| 75.7 | 64.4-87.1 | 185.5 | 157.7-213.4 | 297.3 | 252.7-341.9 | 403.7 | 343.2-464.3 | 525.1 | 446.3-603.8 |

# 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.