(37 days)
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No
The document describes a quality control material for laboratory testing 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 verifying the reportable range for the Cystatin-C analyte. It is not intended to treat or diagnose a disease in a patient.
No
The device is described as an "assayed quality control material" and "linearity/QC material" intended to simulate human patient samples for use in determining linearity, calibration, and verification of reportable ranges for an analyte. It is explicitly for "In Vitro Diagnostic use only" and is a "control material," not a device that directly diagnoses a disease or condition. Control materials are used to ensure the proper functioning and accuracy of diagnostic devices.
No
The device description clearly states it is an "in-vitro diagnostic device consisting of one set of five levels of liquid, linearity/QC material." This describes a physical product, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "The Linearity LQ Cystatin-C is for In Vitro Diagnostic use only."
- Device Description: The "Device Description" also refers to the product as an "in-vitro diagnostic device".
- Intended Use: The intended use is to simulate human patient samples for use in determining linearity, calibration, and the verification of reportable range for the Cystatin-C analyte. This is a typical function of an in vitro diagnostic control material used in laboratory testing.
N/A
Intended Use / Indications for Use
The Linearity LQ Cystatin-C is an assayed quality control material intended to simulate human patient samples for use in determining linearity, calibration, and the verification of reportable range for the Cystatin-C analyte.
The Linearity LQ Cystatin-C is for In Vitro Diagnostic use only.
Product codes (comma separated list FDA assigned to the subject device)
JJX
Device Description
The Audit® MicroControls™ Linearity LQ Cystatin-C product is an in-vitro diagnostic device consisting of one set of five levels of liquid, linearity/QC material. For the set there are five levels labeled A, B, C, D and E. The set contains 1ml for each level. The set contains the Cystatin-C analyte and additives in human and bovine based serum. Materials of human origin used in the manufacture of this linearity set have been tested using FDA approved methods and are found to be non-reactive for HbsAg and antibodies to HCV and HIV-1/2.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Stability studies have been performed to determine the open vial stability and shelf life for Audit® MicroControls™ Linearity LQ Cystatin-C.
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: 3 years, when stored unopened at 2-8º 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.
Open Vial-Accelerated Stability+Real Time Stability: Real time stability studies were conducted at the end of accelerated stability studies to establish the open 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: Open Vial Stability: Once a vial has been opened, the product will be stable for 30 days when stored tightly capped at 2-8° C.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
AALTO SCIENTIFIC, LTD. ROBERT BURDA REGULATORY AFFAIRS MANAGER 1959 KELLOGG AVE. CARLSBAD CA 92008
January 23,2015
Re: K143571
Trade/Device Name: Audit® MicroControls™ Linearity LQ Cystatin-C Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: I. Reserved Product Code: JJX Dated: December 12, 2014 Received: December 17, 2014
Dear Mr. Robert 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 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 (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.
1
If you desire specific advice for your device on our labeling regulations (21 CFR 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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
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Indications for Use
510(k) Number (if known) K143571
Device Name
Audit® MicroControls™ Linearity LQ Cystatin-C
Indications for Use (Describe)
The Linearity LQ Cystatin-C is an assayed quality control material intended to simulate human patient samples for use in determining linearity, calibration, and the verification of reportable range for the Cystatin-C analyte.
The Linearity LQ Cystatin-C is for In Vitro Diagnostic use only.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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
December 12, 2014
B. Device Identification
| Product Trade Name: | Audit® MicroControls™™ Linearity LQ Cystatin-C |
|---|---|
| Common Name: | Single (Specified) Analyte Controls, All Kinds (Assayed and Unassayed) |
| Review Panel: | Clinical Chemistry |
| 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 LQ Cystatin-C 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 Cystatin-C analyte.
The Linearity LQ Cystatin-C is for In Vitro Diagnostic use only.
E. Technical Characteristics Compared to Predicate Device
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| Characteristics | Audit® MicroControls™
Linearity LQ Cystatin-C
(New Device) | Audit® MicroCV™ Beta-
Hydroxybutyric Acid
Linearity Set
(Predicate Device, K130157) | |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Linearity LQ Cystatin-C
is an assayed quality control
material intended to simulate
human patient samples for use
in determining linearity,
calibration verification, and
the verification of reportable
range for the Cystatin-C
analyte.
The Linearity LQ Cystatin-C
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.
The Audit® MicroCVTM
Beta-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 and
bovine based serum | | Human Based Serum |
| Type of
Analytes | Clinical Chemistry | | Clinical Chemistry |
| Form | Liquid | | Liquid |
| Storage | 2-8°C | | 2-8°C |
| Open Vial
Stability | 30 days at 2-8°C | | 40 days at 2-8°C |
| Sterile | No | | No |
| Analytes | Cystatin-C | | Beta-hydroxybutyric acid |
| Number of
Analytes per
Vial | 1 | | 1 |
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F. Device Description
The Audit® MicroControls™ Linearity LQ Cystatin-C product is an in-vitro diagnostic device consisting of one set of five levels of liquid, linearity/QC material. For the set there are five levels labeled A, B, C, D and E. The set contains 1ml for each level. The set contains the Cystatin-C analyte and additives in human and bovine based serum. Materials of human origin used in the manufacture of this linearity set have been tested using FDA approved methods and are found to be non-reactive for HbsAg and antibodies to HCV and HIV-1/2.
G. Value Assignment/Linearity
Analyte value assignment for Level A through Level E was performed on Beckman Immage for the Cystatin-C analyte using the corresponding reagent. The Cystatin-C analyte was measured multiple times. The mean value of the Cystatin-C analyte was used to establish target concentration value at each level. All supporting data is retained on file at Aalto Scientific, Ltd.
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0.4-7.5mg/L
H. Summary of Performance Data
Stability studies have been performed to determine the open vial stability and shelf life for Audit® MicroControls™ Linearity LQ Cystatin-C.
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: 3 years, when stored unopened at 2-8º 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.
Open Vial-Accelerated Stability+Real Time Stability
Real time stability studies were conducted at the end of accelerated stability studies to establish the open 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:
Open Vial Stability: Once a vial has been opened, the product will be stable for 30 days when stored tightly capped at 2-8° C.
I. Expected Values
Analyte value assignment was performed for Audit® MicroControls™ Linearity LQ Cystatin-C on Beckman Immage using the corresponding reagents for Cystatin-C. Cystatin-C was measured multiple times and the mean value was used to establish target concentration values at each level. The target ranges were calculated as ± 10% of the target value.
All supporting data is retained on file at Aalto Scientific. Ltd. Product claims are as follows:
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| Cystatin-C (mg/L)/Beckman Immage | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| 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 |
| 0.649 | 0.584- | ||||||||
| 0.714 | 2.33 | 2.09- | |||||||
| 2.56 | 4.10 | 3.69- | |||||||
| 4.51 | 5.65 | 5.08- | |||||||
| 6.21 | 7.15 | 6.44- | |||||||
| 7.87 |
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.