(31 days)
Not Found
No
The document describes a quality control material for in vitro diagnostic use and does not mention any AI or ML components.
No
This device is an in-vitro diagnostic quality control material used for determining linearity, calibration, and verification of reportable range for unsaturated iron binding capacity. It does not treat or prevent any disease or condition in a patient.
No
This device is described as an "assayed quality control material" and "linearity/QC material" used for determining linearity, calibration, and verification of reportable range for unsaturated iron binding capacity. Its purpose is to ensure the accuracy of other diagnostic tests, not to diagnose a condition itself.
No
The device description clearly states it is an in-vitro diagnostic device consisting of five levels of freeze-dried material in human serum, which are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: Explicitly states "Linearity FD Unsaturated Iron Binding Capacity is for In Vitro Diagnostic use only."
- Device Description: Describes the product as an "in-vitro diagnostic device."
- Intended User/Care Setting: States "In Vitro Diagnostic use only."
The document clearly and repeatedly identifies the device as being for in vitro diagnostic use.
N/A
Intended Use / Indications for 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.
Product codes
JJX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1660 Quality control material (assayed and unassayed).
(a)
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.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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) |
|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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 PRAStaff@fda.hhs.gov
"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: (760) 431-7922 Fax: (760) 431-6942
Contact Person
Robert Burda Regulatory Affairs Manager Telephone: (760) 431-7922 ext. 134 Email: rburda@aaltoscientific.com
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™
Linearity FD Unsaturated Iron
Binding Capacity
(New Device) | Audit® MicroCV™ Beta-
Hydroxybutyric Acid
Linearity Set
(Predicate Device, K130157) |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | 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. |
E. Technical Characteristics Compared to Predicate Device
5
| | | Hydroxybutyric Acid
Linearity Set is “For In Vitro
Diagnostic Use Only”. |
|--------------------------------|--------------------------------------|--------------------------------------------------------------------------------|
| Number of Levels
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
Stability | 30 days at 2-8°C | 40 days at 2-8°C |
| Sterile | No | No |
| Analytes | Unsaturated Iron Binding
Capacity | Beta-hydroxybutyric acid |
| Number of
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 | |||||||||
| value | Target | ||||||||
| Range | Target | ||||||||
| value | Target | ||||||||
| Range | Target | ||||||||
| value | Target | ||||||||
| Range | Target | ||||||||
| value | Target | ||||||||
| Range | Target | ||||||||
| value | Target | ||||||||
| 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.