(36 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description and intended use do not suggest the use of AI/ML.
No
This device is described as "assayed quality control material" and is for "In Vitro Diagnostic use only," intended to determine linearity, calibration, and reportable range for analytes, not for direct therapeutic intervention.
No
This device is described as an "assayed quality control material" and an "in-vitro diagnostic device consisting of five levels of liquid, linearity/QC material," intended for "determining linearity, calibration, and the verification of reportable range for the following analytes." It simulates human patient samples for quality control purposes, rather than directly diagnosing disease.
No
The device description explicitly states it is an in-vitro diagnostic device consisting of five levels of liquid material containing analytes and additives in human serum. This is 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: "Linearity LQ Special Diabetes is for In Vitro Diagnostic use only."
- Device Description: The "Device Description" 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 verification of reportable range for specific analytes (fructosamine, insulin, and C-peptide). This is a typical function of an in vitro diagnostic control material used in laboratory testing.
- Materials: The device contains materials intended to be tested in vitro (outside the body) using laboratory methods.
N/A
Intended Use / Indications for Use
The Linearity LQ Special Diabetes 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: fructosamine, insulin, and C-peptide.
Linearity LQ Special Diabetes is for In Vitro Diagnostic use only.
Product codes
JJY
Device Description
The Audit® MicroControls™ Linearity LQ Special Diabetes product is an in-vitro diagnostic device consisting of five levels of liquid, linearity/QC material, containing Fructosamine, Insulin, C-peptide and additives in human serum. There are five levels labeled A, B, C, D and E which contain 2ml 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 (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 the Audit® MicroControls™ Linearity LQ Special Diabetes.
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: 18 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℃ (Day0 vials). Samples are taken from each lot at 9 months, 18 months and 19 months. The analyte values from the real time vials are compared to the Day() 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 14 days when stored tightly capped at 2-8º C.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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).
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 is a seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 20, 2014
AALTO SCIENTIFIC LTD. ROBERT BURDA REGULATORY AFFAIRS MANAGER 1959 KELLOGG AVE. CARLSBAD CA 92008
Re: K142978
Trade/Device Name: Audit Microcontrols Linearity LO Special Diabetes Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: I, Reserved Product Code: JJY Dated: October 15, 2014 Received: October 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.
Courtney H. Lias -S
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) K142978
Device Name
Audit® MicroControls™ Linearity LQ Special Diabetes
Indications for Use (Describe)
The Linearity LQ Special Diabetes 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: fructosamine, insulin, and C-peptide.
Linearity LQ Special Diabetes 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
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 18, 2014
B. Device Identification
| Product Trade Name: | Audit® MicroControls™ Linearity LQ Special Diabetes |
|---|---|
| Common Name: | Multi-Analyte Controls, All Kinds (Assayed and Unassayed) |
| Review Panel: | Clinical Chemistry and Clinical Toxicology Devices |
| Device Classification: | Class I, Reserved |
| Product Code: | JJY |
| Regulation Number: | 21CFR862.1660 |
C. Device to Which Substantial Equivalence is Claimed
K130157 Audit® MicroCVTM Beta-Hydroxybutyric Acid Linearity Set
D. Intended Use
The Linearity LQ Special Diabetes 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: fructosamine, insulin, and C-peptide.
Linearity LQ Special Diabetes is for In Vitro Diagnostic use only.
4
| Characteristics | Audit® MicroControls™
Linearity LQ Special Diabetes
(New Device) | Audit® MicroCV™ Beta-
Hydroxybutyric Acid
Linearity Set
(Predicate Device, K130157) |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Linearity LQ Special
Diabetes 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:
fructosamine, insulin, and C-
peptide.
Linearity LQ Special Diabetes 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. |
| | | Hydroxybutyric Acid
Linearity Set is “For In Vitro
Diagnostic Use Only”. |
| Number of Levels
per Set | 5 | 5 |
| Contents | 5x2ml | 5x1ml |
| Matrix | Human 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 | 14 days at 2-8°C | 40 days at 2-8°C |
| Sterile | No | No |
| Analytes | Fructosamine, insulin, C-peptide | Beta-hydroxybutyric acid |
| Number of
Analytes per Vial | 3 | 1 |
E. Technical Characteristics Compared to Predicate Device
5
F. Device Description
The Audit® MicroControls™ Linearity LQ Special Diabetes product is an in-vitro diagnostic device consisting of five levels of liquid, linearity/QC material, containing Fructosamine, Insulin, C-peptide and additives in human serum. There are five levels labeled A, B, C, D and E which contain 2ml 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 was performed on Roche Modular P for Fructosamine, Roche Cobas e411 for Insulin and C-peptide by using the corresponding reagent. Each analyte was measured multiple times. The mean value of the analyte was used to establish the target concentration value at each level. All supporting data is retained on file at Aalto Scientific, Ltd.
AMR Values: Fructosamine 10-1000 umol/L C-peptide: 0.01-40 ng/ml Insulin 0.2-1000 µU/ml
H. Summary of Performance Data
Stability studies have been performed to determine the open vial stability and shelf life for the Audit® MicroControls™ Linearity LQ Special Diabetes.
6
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: 18 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℃ (Day0 vials). Samples are taken from each lot at 9 months, 18 months and 19 months. The analyte values from the real time vials are compared to the Dav() 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 14 days when stored tightly capped at 2-8º C.
I. Expected Values
Value assignment of Audit® MicroControls™ Linearity LQ Special Diabetes have been performed to determine the expected values of the fructosamine, insulin and C-peptide analytes. Each analyte value assignment for Level A through Level E is performed on Roche Modular P for Fructosamine, Roche Cobas e411 for Insulin and C-peptide by using the corresponding reagents. 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:
| Fructosamine (µmol/L)/Roche Modular P | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| 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 |
| 24.10 | 20.49-27.72 | 258.25 | 219.52- | ||||||
| 296.99 | 496.44 | 421.97- | |||||||
| 570.91 | 748.14 | 635.92- | |||||||
| 860.36 | 975.70 | 829.35- | |||||||
| 1122.06 |
7
| Insulin (µU/mL) Roche Cobas e411 | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| 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 |
| 1.37 | 1.17-1.58 | 233.78 | 198.71- | ||||||
| 268.85 | 456.20 | 387.77- | |||||||
| 524.63 | 628.08 | 533.87- | |||||||
| 722.29 | 814.79 | 692.57- | |||||||
| 937.00 |
| C-peptide (ng/mL)/Roche Cobas e411 | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| 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 | |||||||||
| 0.32 | 0.27-0.37 | 9.27 | 7.88-10.66 | 18.22 | 15.49-20.96 | 26.96 | 22.91-31.00 | 35.37 | 30.07-40.68 |
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.