(235 days)
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No
The document describes a quality control material for chemistry analyzers and does not mention any AI or ML components.
No.
This device is an in vitro diagnostic quality control material used to confirm the proper calibration and linear operating range of analytical instruments for specific analytes, not for treating diseases or conditions.
No
This device is a quality control material used to confirm the proper calibration and linear operating range of analytical instruments, not to diagnose a patient's condition.
No
The device description clearly states it is an "aqueous buffer based, lyophilized" material, indicating a physical substance, 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™ MicroCV™ Urine/Fluids Chemistry Linearity Set is 'For In Vitro Diagnostic Use Only'".
- Intended Use: The device is intended for use with quantitative assays on analyzers to confirm proper calibration, linear operating range, and reportable range of various analytes in urine and fluid samples. This is a classic function of an in vitro diagnostic control material.
- Device Description: The description details the composition and purpose of the material, which is to be used in laboratory testing to assess the performance of diagnostic instruments and assays.
Therefore, based on the provided information, the Audit™ MicroCV™ Urine/Fluids Chemistry Linearity Set is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Audit™ MicroCV™ Urine/Fluids Chemistry Linearity Set is assayed quality control material consisting of two sets of five levels of aqueous buffer. Each level of Set 1 contains the following analytes: Phosphorous, Urea Nitrogen, Uric Acid. Each level of Set 2 contains the following analytes: Amylase, Calcium, Glucose, Chloride, Creatinine, Magnesium, Potassium, Sodium, Microalbumin. These five levels of each set demonstrate a linear relationship to each other for their respective analytes, reagents and instruments.
The product is intended for use with quantitative assays on the indicated analyzer specified in the labeling. 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™ Urine/Fluids Chemistry 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™ Urine/Fluids Chemistry Linearity is a aqueous buffer based, lyophilized, two five level sets of QC material, with each level of the first set containing Phosphorous, Urea Nitrogen, Uric Acid.and the second set containing Amylase, Calcium, Chloride, Creatinine, Glucose, Magnesium, Microalbumin, Microprotein, Potassium, Sodium. It is used to confirm the proper calibration, linear operating range, and reportable range of Phosphorous, Urea Nitrogen, Uric Acid, Amylase, Calcium, Chloride, Creatinine, Glucose, Magnesium, Microalbumin, Microprotein, Potassium, Sodium 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
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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 reconstituted stability and shelf life for the Audit® MicroCV™ Urine/Fluids Chemistry Linearity Set. All supporting data is retained on file at Aalto Scientific, Ltd. Product claims are as follows:
Reconstituted Stability: Once a vial has been reconstituted, all analytes from Set 1 will be stable for 72 hours when stored tightly capped at 2 - 8° C. All analytes from Set 2 will be stable for 10 days when stored tightly capped at 2 - 8º C.
Shelf Life: One year, when stored unopened 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.)
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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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MAR - 2 2012
510(k) Summary
A. Submitter
Aalto Scientific, Ltd. 1959 Kellogg Ave. Carlsbad, CA 92008 Telephone: (760) 431-7922 Fax: (760) 431-6824
B. Contact Person
Dessi Lyakov Regulatory Affairs Manager Telephone: (760) 431-7922 Ext. 118 E-mail: dlyakov@aaltoscientific.com
C. Date of Summary Preparation
February 29, 2012
D. Device Identification
| Product Trade Name: | Audit® MicroCV™ Urine/Fluids Chemistry Linearity |
|---|---|
| Common Name: | Urine/Fluids Chemistry Linearity |
| Classification Name: | Assay QC Material |
| Device Classification: | Class I |
| Regulation Number: | 21 CFR 862.1660 |
| Panel: | 75 |
| Product Code: | JJY |
| Device to Which Substantial Equivalence is Claimed | |
| Product Trade Name: | Audit® MicroCV™ General Chemistry Linearity Set |
| Aalto Scientific, Ltd., Carlsbad, CA | |
| K042318 |
E. Description of the Device
The Audit® MicroCV™ Urine/Fluids Chemistry Linearity is a aqueous buffer based, lyophilized, two five level sets of QC material, with each level of the first set containing Phosphorous, Urea Nitrogen, Uric Acid.and the second set containing Amylase, Calcium,
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Chloride, Creatinine, Glucose, Magnesium, Microalbumin, Microprotein, Potassium, Sodium. It is used to confirm the proper calibration, linear operating range, and reportable range of Phosphorous, Urea Nitrogen, Uric Acid, Amylase, Calcium, Chloride, Creatinine, Glucose, Magnesium, Microalbumin, Microprotein, Potassium, Sodium 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.
F. Statement of Intended Use
The Audit™ MicroCV™ Urine/Fluids Chemistry Linearity Set is assayed quality control material consisting of two sets of five levels of aqueous buffer. Each level of Set 1 contains the following analytes: Phosphorous, Urea Nitrogen, Uric Acid. Each level of Set 2 contains the following analytes: Amylase, Calcium, Glucose, Chloride, Creatinine, Magnesium, Potassium, Sodium, Microprotein, Microalbumin, These five levels of each set demonstrate a linear relationship to each other for their respective analytes, reagents and instruments.
The product is intended for use with quantitative assays on the indicated analyzer specified in the labeling. 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™ Urine/Fluids Chemistry Linearity Set is "For In Vitro Diagnostic Use Only".
G. Summary of Performance Data
Stability studies have been performed to determine the reconstituted stability and shelf life for the Audit® MicroCV™ Urine/Fluids Chemistry Linearity Set. All supporting data is retained on file at Aalto Scientific, Ltd. Product claims are as follows:
Reconstituted Stability: Once a vial has been reconstituted, all analytes from Set 1 will be stable for 72 hours when stored tightly capped at 2 - 8° C. All analytes from Set 2 will be stable for 10 days when stored tightly capped at 2 - 8º C.
Shelf Life: One year, when stored unopened 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 | Audit® MicroCV™ Urine/Fluids Chemistry
Linearity Set
(K111964) | Audit™ MicroCV™ General Chemistry
Linearity Set
(K042318) |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Audit™ MicroCV™ Urine/Fluids Chemistry
Linearity Set is assayed quality control material
consisting of two sets of five levels of aqueous
buffer. Each level of Set 1 contains the following
analytes: Phosphorous, Urea Nitrogen, Uric
Acid. Each level of Set 2 contains the following
analytes: Amylase, Calcium, Glucose, Chloride,
Creatinine, Magnesium, Potassium, Sodium,
Microprotein, Microalbumin. These five levels of
each set demonstrate a linear relationship to
each other for their respective analytes,
reagents and instruments.
The product is intended for use with quantitative
assays on the indicated analyzer specified in
the labeling. 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™
Urine/Fluids Chemistry Linearity Set is "For In
Vitro Diagnostic Use Only". | Audit® MicroCV™ 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, LDH, Glucose,
HDL Cholesterol, Iron, Lactate, 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 |
| Number of
Analytes per vial | Set 1
3
| Set 2
30 |
| Number of
levels per set | 5 | |
| Contents | 10 x 2 mL | 5 x 5 mL |
| Matrix | Aqueous Based Buffer | Human Based Serum |
| Type of Analytes | Amylase, Calcium, Glucose, Chloride,
Creatinine, Magnesium, Potassium, Sodium,
Microprotein, Microalbumin, Phosphorous, Urea
Nitrogen Uric Acid,. | Albumin, ALP, ALT, Amylase, AST, Bilirubin
(Total and Direct), BUN, Calcium, Chloride,
Cholesterol, CO2, Creatine Kinase, Creatinine,
Gamma-GT, Glucose, Iron, HDL Cholesterol,
Lactate, LDH, LDL Cholesterol, Lipase,
Magnesium, Phosphorus, Potassium, Sodium,
Total Protein, Triglycerides and Uric Acid. |
| Form | Lyophilized | Lyophilized |
| Storage | 2 to 8° C
Until expiration date | 2 to 8° C
Until expiration date |
| Reconstituted
Stability | 72 hours at 2 to 8° C for Set 1
10 days at 2 to 8° C for Set 2 | 1 day at 2 to 8° |
l. 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.
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Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all caps. The text is in a bold, sans-serif font and is centered horizontally. The words are arranged on a single line.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Aalto Scientific c/o Dessi Lyakov 1959 Kellogg Ave. Carlsbad, CA 92008
MAR - 2 2012
Re: K111964
Trade/Device Name: Audit™ MicroCV Urine/Fluids Chemistry Linearity
Regulation Number: 21 CFR 862.1660
Regulation Name: Quality Control Material (Assayed and Unassayed) Regulatory Class: Class I, reserved Product Code: JJY Dated: February 2, 2012 Received: February 6, 2012
Dear Ms. Lyakov:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section >10(t) prematic is substantially equivalent (for the indications
referenced above and have determined the devices marketed in interstate referenced above and have determined the devices marketed in interstate for use stated in the enclosure) to tegally managed to of the Medical Device Amendmiss, or to
commerce prior to May 28, 1976, the enactment the the prosions of the Federal Fo commerce prior to May 28, 1970, the enactinent and of the Federal Food, Drug, devices that have been reclassified in accordance who approval application (PMA).
and Cosmetic Act (Act) that do not require approval approval applisions of the Act. The and Cosmetic Act (Act) that do not require approvations provisions of the Act. The Act. The Act. The You may, therefore, market the uevice, saujer requirements for annual registration, listing of
general controls provisions of the Act include requirements for annual misbrand general controls provisions of the Act mende requirement.
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 If your device is classified (see and regulations affecting your device can be found in Title 21,
additional controls. Existing major regulations affecting your devices furth additional controls. Existing major tegulations areoting your Code of rederal Regulations (OFF), - - - - - - - - - - - - - - - - - - - - - - - - - -
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA's issuance of a subscanting with other requirements of the Act
that FDA has made a determination that your device Federal by other requirements. Y that FDA has made a determination that your device by other Federal agencies. You must
or any Federal statutes and regulations administered by other registration and listing or any Federal statutes and regilations and institution in the mass of the may isting (21
comply with all the Act's requirements, including but not institute of comply with all the Act s requirements, including, our innines in one of engorting of
CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting practice CFR Part 807); labeling (21 CFR Fats 601 ma 603); and eood manufacturing practice
medical device-related adverse events) (21 cms (OS); and sood manufacturing practice medical device-related adverse events) (21 CPX 00-5), and good (21 CFR Part 820). This letter
requirements as set forth in the quality systems (QS) cegulation (21 CFR Part R requirements as set forth in the quality systems (co) regality (us Section 510(k) premarket
will allow you to begin marketing your device of your Section 510(k) marketed will allow you to begin marketing your device of your device to a legally marketed
notification. The FDA finding of substantial equivalence of your device to notification. The FDA finding of substantial equivalence or your device and thus, permits your device to proceed to the market.
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Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical
Devices/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) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm
Sincerely yours,
N
Counney H. Lias, Ph.D. Director
Division of Chemistry and Toxicology 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: K111964
Device Name: Audit® MicroCV™ Urine/Fluids Chemistry Linearity
Indications For Use:
The Audit™ MicroCV™ Urine/Fluids Chemistry Linearity Set is assayed quality control material consisting of two sets of five levels of aqueous buffer. Each level of Set 1 contains the following analytes: Phosphorous, Urea Nitrogen, Uric Acid. Each level of Set 2 contains the following analytes: Amylase, Calcium, Glucose, Chloride, Creatinine, Magnesium, Potassium, Sodium, Microalbumin. These five levels of each set demonstrate a linear relationship to each other for their respective analytes, reagents and instruments.
The product is intended for use with quantitative assays on the indicated analyzer specified in the labeling. 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™ Urine/Fluids Chemistry Linearity Set is "For In Vitro Diagnostic Use Only".
. X Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
g.
Office of In Vito Diagnostic Device Evaluation and Safety
510(k) K111964