(120 days)
Not Found
No
The device is a quality control material used to verify the linearity of assays, not a diagnostic or analytical device that would typically incorporate AI/ML. The description focuses on the chemical composition and intended use for calibration verification.
No
This device is a quality control material intended for in vitro diagnostic use to verify calibration and linearity of assays, not to treat or diagnose a disease.
No
Explanation: The device is described as a "quality control material" and "quality control solution set" used to confirm calibration and linearity of assays for RF and CRP. It is "For In Vitro Diagnostic Use Only" but its purpose is to ensure the proper functioning of diagnostic devices, not to diagnose a patient directly.
No
The device is a physical quality control material (serum-based solution) used with laboratory analyzers, not a software application.
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™ MicroCV™ RF/CRP Linearity Set is 'For In Vitro Diagnostic Use Only'".
- Intended Use: The intended use is to be used with quantitative assays on analyzers to verify calibration, linear operating range, and reportable range of RF and CRP. This is a classic function of an in vitro diagnostic device used in a laboratory setting to assess the performance of diagnostic tests.
- Device Description: The device description further clarifies its use as a quality control solution set for measuring C-reactive protein and Rheumatoid Factor, which are analytes measured in diagnostic tests.
- Care Setting: The intended user and care setting are described as a laboratory setting, which is where IVD devices are typically used.
- Predicate Devices: The listed predicate devices are also IVD devices (e.g., "LiniCAL Calibration Verifier RF/CRP CLINIQA", "Liquichek Lipids Control Bio-Rad Laboratories", "Audit MicroCV General Chemistry Linearity Set Aalto Scientific, Ltd."). This further supports the classification of this device as an IVD.
N/A
Intended Use / Indications for Use
The Audit™ MicroCV™ RF/CRP Linearity Set is an assayed quality control material consisting of five levels human based serum. Each level contains Rheumatoid Factor (RF) and C-Reactive Protein (CRP) analytes. The five levels demonstrate a linear relationship to each other for Rheumatoid Factor (RF) and C-Reactive Protein (CRP) analytes. This product may also be used as unassayed quality control material for Rheumatoid Factor (RF) and C-Reactive Protein (CRP) 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 product is intended for use with quantitative assays on manual, automatic, and semi-automatic analyzers. The Audit™ MicroCVTM RF/CRP Linearity Set is "For In Vitro Diagnostic Use Only".
Product codes (comma separated list FDA assigned to the subject device)
JJY
Device Description
The Audit™ MicroCV™ RF/CRP Linearity Set is a 5 level quality control solution set containing C-reactive protein and Rheumatoid Factor as the messurand. It is used to confirm the proper calibration, linear operating range, and reportable range of RF and CRP. Level A is near the lower limit level and Level E has concentrations near the upper limit of instruments. Levels B - D are related by linear dilution of Level A and Level E.
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™ MicroCV™ RF/CRP Linearity Set. All supporting data is retained on file at Aalto Scientific. Ltd. Product claims are as follows:
Open Vial Stability: Once a vial has been reconstituted, all analytes will be stable for 5 days when stored tightly capped at 2-8 C.
Shelf Life: 19 months at 2 - 8º C.
Note: Real time studies are ongoing to support the shelf life of this product.
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.
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Image /page/0/Picture/0 description: The image shows a logo with a triangular shape at the top, filled with a pattern of small crosses or dots, giving it a textured appearance. Below the triangle, there is text that reads "Aalto Scientific, Ltd." The text is in a simple, sans-serif font and is positioned directly under the triangular symbol.
510(k) Summary
KID1226
A. Submitter
AUG 3 1 2010
Aalto Scientific, Ltd. 1959 Kellogg Ave. Carlsbad, CA 92008 Telephone: (760) 431-7922 Fax: (760) 431-6824
B. Contact Person
Dessi Lyakov Telephone: (760) 431-7922 Ext. 118 E-mail: dlyakov@aaltoscientific.com
C. Date of Summary Preparation
April 30, 2010
D. Device Identification
Product Trade Name: Common Name: Classification Name: Device Classification: Regulation Number: Panel: Product Code:
Audit™ MicroCV™ RF/CRP Linearity Set Calibration Verification Multi analyte controls (Assayed and Unassayed) Class I 21 CFR 862.1660 75 JJY
E. Device to Which Substantial Equivalence is claimed
Product Trade Name:
LiniCAL Calibration Verifier RF/CRP CLINIQA, Fallbrook, CA 92028 K023661
Liquichek Lipids Control Bio-Rad Laboratories, Irvine, California K012513
Audit MicroCV General Chemistry Linearity Set Aalto Scientific, Ltd., Carlsbad, California K042318
نو
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F. Description of the Device
The Audit™ MicroCV™ RF/CRP Linearity Set is a 5 level quality control solution set containing C-reactive protein and Rheumatoid Factor as the messurand. It is used to confirm the proper calibration, linear operating range, and reportable range of RF and CRP. Level A is near the lower limit level and Level E has concentrations near the upper limit of instruments. Levels B - D are related by linear dilution of Level A and Level E.
G. Statement of Intended Use
The Audit™ MicroCV™ RF/CRP Linearity Set is an assayed quality control material consisting of five levels human based serum. Each level contains Rheumatoid Factor (RF) and C-Reactive Protein (CRP) analytes. The five levels demonstrate a linear relationship to each other for Rheumatoid Factor (RF) and C-Reactive Protein (CRP) analytes. This product may also be used as unassayed quality control material for Rheumatoid Factor (RF) and C-Reactive Protein (CRP) 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 product is intended for use with quantitative assays on manual, automatic, and semi-automatic analyzers. The Audit™ MicroCV™ RF/CRP Linearity Set is "For In Vitro Diagnostic Use Only".
I. Summary of Performance Data
Stability studies have been performed to determine the open vial stability and shelf life for the Audit™ MicroCV™ RF/CRP Linearity Set. All supporting data is retained on file at Aalto Scientific. Ltd. Product claims are as follows:
Open Vial Stability: Once a vial has been reconstituted, all analytes will be stable for 5 days when stored tightly capped at 2-8 C.
Shelf Life: 19 months at 2 - 8º C.
Note: Real time studies are ongoing to support the shelf life of this product.
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H. Technical Characteristics Compared to Predicate Device
| Characteristics | AuditTM
MicroCVTMRF/CRP
Linearity Set (K101226) | Bio-Rad Liquichek
Lipids Control
(K012513) | AuditTM MicroCVTM
General Chemistry
Linearity Set (K042318) | LiniCAL
Calibration Verifier
RF/CRP (K023661) |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The AuditTM
MicroCVTM RF/CRP
Linearity Set is an
assayed quality control
material consisting of
five levels human based
serum. Each level
contains Rheumatoid
Factor (RF) and C-
Reactive Protein (CRP)
analytes. The five levels
demonstrate a linear
relationship to each
other for Rheumatoid
Factor (RF) and C-
Reactive Protein (CRP)
analytes. This product
may also be used as
unassayed quality
control material for
Rheumatoid Factor
(RF) and C-Reactive
Protein (CRP) 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
product is intended for
use with quantitative
assays on manual,
automatic, and semi-
automatic analyzers.
The AuditTM
MicroCVTM RF/CRP
Linearity Set is "For In
Vitro Diagnostic Use
Only". | Liquichek Lipids
Control is intended
for use as an
assayed quality
control serum to
monitor the
precision of
laboratory testing
procedures for the
listed analytes. | Audit® MicroCVTM General
Chemistry Linearity Set
consists of five levels of
human based serum. Each
level contains the following
analytes: Albumin, Alkaline
Phosphatase, ALT,
Amylase, AST, Bilirubin
(Total and Direct), BUN,
Calcium, Chloride,
Cholesterol, CO2 Creatine
Kinase, Creatinine, Gamma-
GT, Glucose, HDL
Cholesterol, Iron, Lactate,
LDH, LDL Cholesterol,
Lipase, Magnesium,
Phosphorus, Potassium,
Sodium, Total Protein,
Triglycerides and Uric Acid.
These five levels
demonstrate a linear
relationship to each other for
their respective analytes,
reagents and instruments1.
This product may also be
used as unassayed 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. In addition,
it may be used for
proficiency testing in
interlaboratory surveys and
to perform CLIA directed
calibration verification2 for
these same analytes in
accordance with current
CLIA-88 guidelines and
regulations3 | LiniCAL
Calibration Verifier
RF/CRP is intended
for use in the
clinical laboratory
to objectively verify
calibration and
assess linearity
regarding RF and
CRP. Five targeted
assayed materials
are provided to
allow monitoring
the manufacturer's
reportable range. |
| | | | | |
| Number of
Analytes per vial | 2 | 8 | 31 | 2 |
| Number of levels
per set | 5 | 2 | 5 | 5 |
| Contents | 5 x 1 mL | 2 x 3mL | 5 x 1mL | 5 x 1mL |
| Matrix | Human Serum | Human Serum | Human Serum | Human Serum |
| Type of Analytes | C-Reactive Protein
Rheumatoid Factor | C-Reactive Protein
Apolipoprotein A-1
Apolipoprotein B
Cholesterol
HDL Cholesterol
LDL Cholesterol
Lipoprotein (a)
Triglycerides | Albumin, Alkaline
Phosphatase, ALT,
Amylase, AST, Bilirubin
(Total and Direct), BUN,
Calcium, Chloride,
Cholesterol, CO₂
Creatine Kinase.
Creatinine, Gamma-GT.
Glucose, HDL
Cholesterol, Iron.
Lactate, LDH, LDL
Cholesterol, Lipase.
Magnesium, Phosphorus,
Potassium, Sodium,
Total Protein,
Triglycerides and Uric
Acid. | Rheumatoid Factor (RF)
C-Reactive Protein (CRP) |
| Form | Liquid | Liquid | Lyophilized | Liquid |
| Storage | 2 to 8° C for 19 months | -20°C to -70°C for 36
months | 2 to 8° C for 48 months | 2 to 8° C for 48 months |
| Open Bottle
Stability | 5 days at 2 to 8° C | 14 days at 2 to 8°C | 7 days at 2 to 8° C | 14 days at 2 to 8°C |
:
:
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J. SIMILARITIES AND DIFFERENCES between the Audit™
MicroCVTMRF/CRP Linearity Set (K101226) and the Predicate Devices
Similarities between the Audit™ MicroCV™RF/CRP Linearity Set (K101226) and all Predicate Devices:
- . All products are human serum based quality control materials intended to monitor the precision of laboratory testing procedures for the listed analytes.
- All products were made using the same method of spiking various constituents to . human based matrix.
- All products content multiple levels. 트
- Audit™ MicroCV™RF/CRP Linearity Set (K101226) and LiniCAL Calibration 트 Verifier RF/CRP (K023661) have the same analytes.
Diferences between the Audit™ MicroCV™RF/CRP Linearity Set (K101226) and all Predicate Devices:
- Audit™ MicroCV™RF/CRP Linearity Set (K101226), Bio-Rad Liquichek . Lipids Control (K012513), and LiniCAL Calibration Verifier RF/CRP (K023661) are liquid products Audit™ MicroCV™ General Chemistry Linearity Set (K042318) is lyophilized product.
- Audit™ MicroCVTMRF/CRP Linearity Set (K101226), Bio-Rad Liquichek . Lipids Control (K012513), and LiniCAL Calibration Verifier RF/CRP (K023661) have different analytes.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with outstretched wings, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
AUG 3 1 2010
Aalto Scientific, Ltd. c/o Ms. Dessi Lyakov Manager, Regulatory Affairs 1959 Kellogg Ave. Carlsbad, CA 92008
Re: K101226
Trade/Device Name: Audit™ MicroCV™ RF/CRP Linearity Set Regulation Number: 21 CFR§862.1660 Regulation Name: Quality Control Material (assayed and unassayed) Regulatory Class: Class I (Reserved) Product Code: JJY Dated: August 18, 2010 Received: August 18, 2010
Dear Ms. Lyakov:
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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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
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Page 2 - Ms. Dessi Lyakov
CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours. marrow in chan
Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number: K101226
Device Name: Audit™ MicroCV™ RF/CRP Linearity Set
Indications For Use:
The Audit™ MicroCV™ RF/CRP Linearity Set is an assayed quality control material consisting of five levels human based serum. Each level contains Rheumatoid Factor (RF) and C-Reactive Protein (CRP) analytes. The five levels demonstrate a linear relationship to each other for Rheumatoid Factor (RF) and C-Reactive Protein (CRP) analytes. This product may also be used as unassayed quality control material for Rheumatoid Factor (RF) and C-Reactive Protein (CRP) 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 product is intended for use with quantitative assays on manual, automatic, and semi-automatic analyzers. The Audit™ MicroCVTM RF/CRP Linearity Set is "For In Vitro Diagnostic Use Only".
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
AUG 3 1 2010
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Reena Philip
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510K k10/226