(78 days)
Not Found
No
The device description and performance studies focus on the stability and expected values of a linearity control material, with no mention of AI or ML algorithms for analysis or interpretation.
No
The device is an in-vitro diagnostic device used to simulate human patient samples for quality control and calibration verification of tumor markers, not to treat a condition or disease.
No
This device is described as "assayed quality control material" and is used for "determining linearity, calibration verification of reportable range" for analytes. It simulates human patient samples but does not directly diagnose a patient's condition. While it is an "In Vitro Diagnostic device," its function is for quality control and calibration of diagnostic tests, not for diagnosing patients itself.
No
The device description explicitly states it is an in-vitro diagnostic device consisting of sets of freeze-dried linearity material and additives in human based serum, which are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "The Audit® MicroControlsTM Linearity FD Tumor Markers II is for In Vitro Diagnostic use only."
- Device Description: The "Device Description" section also states: "The Audit® MicroControls™ Linearity FD Tumor Markers II is an in-vitro diagnostic device..."
- Intended Use: The intended use is to simulate human patient samples for use as assayed quality control material, determining linearity, and calibration verification of reportable range for specific analytes (HE4 and HER2). This is a typical function of an in vitro diagnostic control material used in laboratory testing.
- Analytes: The device contains analytes (HE4 and HER2) that are measured in biological samples (human serum) to provide information about a patient's health status (tumor markers).
All of these points clearly indicate that the device is intended for use in a laboratory setting to perform tests on biological samples outside of the body, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Audit® MicroControls™ Linearity FD Tumor Markers II is intended to simulate human patient samples for use as assayed quality control material, determining linearity, calibration verification, and the verification of reportable range for the HE4 and HER2 analytes.
The Audit® MicroControls™ Linearity FD Tumor Markers II is for In Vitro Diagnostic use only.
Product codes
JJX, JJY
Device Description
The Audit® MicroControls™ Linearity FD Tumor Markers II is an in-vitro diagnostic device consisting of sets of 5 levels of freeze-dried, linearity material and additives in human based serum. The product contains the following analytes: HE4 and HER2. Each set consists of 5 levels labeled Level A, B, C, D and E. Each level has a fill size of 1ml. 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 open 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. Acceptance criteria were met to support the product claims as follows: Shelf Life: 2 years, when stored unopened at 2-8º C.
Shelf Life-Real Time Stability: Real time studies are ongoing to support the shelf life of this product.
Open Vial Stability: Real time stability studies were conducted to establish the open vial stability claims. 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 7 days when stored tightly capped at 2-8º C.
Expected Values: Analyte value assignment was performed for Audit® MicroControls™ Linearity FD Tumor Markers II using the corresponding reagents for HE4 and HER2. Each analyte was measured multiple times and the mean value was used to establish target concentration values at each level.
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.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol consists of three stylized human profiles facing to the right, stacked on top of each other, with flowing lines suggesting movement or connection. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 10, 2017
AALTO SCIENTIFIC, LTD. ROBERT BURDA REGULATORY AFFAIRS DIRECTOR 230 TECHNOLOGY PARKWAY EATONTON GA 30642
Re: K163629
Trade/Device Name: Audit® MicroControls™ Linearity FD Tumor Markers II Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: I, Reserved Product Code: JJX Dated: December 21, 2016 Received: January 11, 2017
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,
Kelly Oliner -S
For
Leonthena Carrington, MBA, MS, MT(ASCP) Director Division of Immunology and Hematology 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) K163629
Device Name Audit® MicroControls™ Linearity FD Tumor Markers II
Indications for Use (Describe)
The Audit® MicroControls™ Linearity FD Tumor Markers II is intended to simulate human patient samples for use as assayed quality control material, determining linearity, callbration verification of reportable range for the HE4 and HER2 analytes.
The Audit® MicroControlsTM Linearity FD Tumor Markers II 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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3
510(k) Summary: K163629
A. Submitter
Aalto Scientific, Ltd. 230 Technology Parkway Eatonton, GA 31024 Telephone: (760) 431-7922 Fax:
Contact Person
Robert Burda Regulatory Affairs Director Telephone: (760) 444-8756 Email: rburda@aaltoscientific.com
Date of Summary Preparation
March 06, 2017
B. Device Identification
| Product Trade Name: | Audit® MicroControls™ Linearity FD Tumor Markers II |
|---|---|
| Common Name: | Multi-Analyte Controls (Assayed and 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
K130762: Audit® MicroCV ™ Therapeutic Drug (TDM) Linearity Set
D. Intended Use
The Audit® MicroControls™ Linearity FD Tumor Markers II is intended to simulate human patient samples for use as assayed quality control material, determining linearity, calibration verification, and the verification of reportable range for the HE4 and HER2 analytes.
The Audit® MicroControls™ Linearity FD Tumor Markers II is for In Vitro Diagnostic use only.
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E. Technical Characteristics Compared to Predicate Device
| Characteristics | (New Device, K163629)
Audit® MicroControls™
Linearity FD Tumor Markers II | (Predicate Device, K130762)
Audit® MicroCV™
Therapeutic Drug (TDM)
Linearity Set |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Audit® MicroControls™
Linearity FD Tumor Markers II
is intended to simulate human
patient samples for use as
assayed quality control
material, determining
linearity, calibration
verification, and the
verification of reportable
range for the HE4 and HER2
analytes.
The Audit® MicroControls™
Linearity FD Tumor Markers II
is for In Vitro Diagnostic use
only. | The Audit® MicroCV™
Therapeutic Drug (TDM)
Linearity Set is an assayed
quality control material
consisting of five levels of
human based serum. Each
level contains:
Acetaminophen, Amikacin,
Carbamazepine, Digoxin,
Gentamicin, Lithium,
Methotrexate, Phenobarbital,
Phenytoin, Quinidine,
Salicylate, Theophylline,
Tobramycin, Valproic Acid
and Vancomycin. These five
levels demonstrate a linear
relationship to each other for
their respective analytes. It is
intended to simulate human
patient serum samples for
purpose of determining
linearity, calibration
verification and verification of
reportable range for
Acetaminophen, Amikacin,
Carbamazepine, Digoxin,
Gentamicin, Lithium,
Methotrexate, Phenobarbital,
Phenytoin, Quinidine,
Salicylate, Theophylline,
Tobramycin, Valproic Acid
and Vancomycin. 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 these
analytes. 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™
Therapeutic Drug (TDM)
Linearity Set should not be
used for calibration or
standardization of the
Acetaminophen, Amikacin,
Carbamazepine, Digoxin,
Gentamicin, Lithium,
Methotrexate, Phenobarbital,
Phenytoin, Quinidine,
Salicylate, Theophylline,
Tobramycin, Valproic Acid
and Vancomycin assays.
The Audit® MicroCV™
Therapeutic Drug (TDM)
Linearity Set is "For In Vitro
Diagnostic Use Only". |
| Matrix | Human Serum | Human Serum |
| Type of
Analytes | Clinical Chemistry | Clinical Chemistry |
| Form | Freeze-dried powder | Freeze-dried powder |
| Storage | 2-8°C | 2-8°C |
| Shelf Life | 2 years at 2-8°C | 2 years at 2-8°C |
| Open Vial
Stability | 7 days at 2-8°C | 7 days at 2-8°C |
| Sterile | No | No |
| Analytes | HE4, HER2 | Acetaminophen, amikacin,
carbamazepine, digoxin,
gentamicin, lithium,
phenobarbital, phenytoin,
quinidine, salicylate,
theophylline, tobramycin,
valproic acid, and
vancomycin |
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F. Device Description
The Audit® MicroControls™ Linearity FD Tumor Markers II is an in-vitro diagnostic device consisting of sets of 5 levels of freeze-dried, linearity material and additives in human based serum. The product contains the following analytes: HE4 and HER2. Each set consists of 5 levels labeled Level A, B, C, D and E. Each level has a fill size of 1ml. 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.
6
G. Value Assignment/Linearity
The mean and expected range for each method shall be presented in each lot specific insert of Audit® MicroControls™ Linearity FD Tumor Markers II. The indicated values shall be derived from analysis of vials representative of the entire lot. Analyte value assignment for Level A through Level E was performed on Siemens Centaur XP for the HER2 analyte and the Roche Cobas e411 for the HE4 analyte using the corresponding reagents. The analytes were measured multiple times. The mean value of each analyte was used to establish a tarqet concentration value at each level. All supporting data is retained on file at Aalto Scientific, Ltd.
H. Summary of Performance Data
Stability studies have been performed to determine the open 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 2-8º C.
Shelf Life-Real Time Stability
Real time studies are ongoing to support the shelf life of this product.
Open Vial Stability
Real time stability studies were conducted 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 7 days when stored tightly capped at 2-8º C.
-Expected Values
Analyte value assignment was performed for Audit® MicroControls™ Linearity FD Tumor Markers II using the corresponding reagents for HE4 and HER2. Each analyte was measured multiple times and the mean value was used to establish target concentration values at each level. The target ranges are shown below.
The expected range of the mean is provided to assist the laboratory until it has established its own mean and standard deviation. The indicated mean and expected range (target range) of the mean is provided to serve only as a quide in assessing the performance of the test method in laboratories.
7
Approximate target values for HE4 and HER2 are given in the table below. Lot-specific target values may differ after value assignment.
| HE4/Roche Cobas e411 (pmol/L) | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| 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 |
| 20.5 | 16.4- | ||||||||
| 24.6 | 380.6 | 304.5- | |||||||
| 456.7 | 783.9 | 627.1- | |||||||
| 940.7 | 1217.8 | 974.2- | |||||||
| 1461.4 | 1461.0 | 1168.8- | |||||||
| 1753.2 |
| HER2/Siemens Centaur XP (ng/ml) | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| 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 |
| 5.1 | 4.1-6.1 | 74.0 | 59.2- | ||||||
| 88.8 | 146.0 | 116.8- | |||||||
| 175.2 | 241.3 | 193.1- | |||||||
| 289.6 | 303.0 | 242.4- | |||||||
| 363.7 |
Levels B, C and D produced according to the following dilution scheme:
Level B = 0.75(Level A) + 0.25(Level E)
Level C = 0.5(Level A) + 0.5(Level E)
Level D = 0.25(Level A) + 0.75(Level E)
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.