(235 days)
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".
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.
The provided text describes a 510(k) premarket notification for a medical device called "Audit® MicroCV™ Urine/Fluids Chemistry Linearity". This device is a quality control material used to confirm the proper calibration, linear operating range, and reportable range of various analytes in urine and fluid chemistry.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission claims substantial equivalence to a predicate device (Audit® MicroCV™ General Chemistry Linearity Set (K042318)). The performance criteria are primarily focused on stability and linearity, demonstrating that the new device performs similarly to the predicate.
| Characteristic | Acceptance Criteria (Implied by Substantial Equivalence to Predicate K042318) | Reported Device Performance (Audit® MicroCV™ Urine/Fluids Chemistry Linearity K111964) |
|---|---|---|
| Intended Use | Assayed QC material demonstrating linear relationship for analytes, reagents, and instruments. For in vitro diagnostic use. | The Audit™ MicroCV™ Urine/Fluids Chemistry Linearity Set is assayed quality control material consisting of two sets of five levels of aqueous buffer. These five levels of each set demonstrate a linear relationship to each other for their respective analytes, reagents and instruments. "For In Vitro Diagnostic Use Only". |
| Number of Analytes | Set 1: 30 analytes (for predicate General Chemistry) | Set 1: 3 analytes (Phosphorous, Urea Nitrogen, Uric Acid) Set 2: 11 analytes (Amylase, Calcium, Glucose, Chloride, Creatinine, Magnesium, Potassium, Sodium, Microprotein, Microalbumin) |
| Number of Levels per Set | 5 | 5 |
| Contents | 5 x 5 mL | 10 x 2 mL |
| Matrix | Human Based Serum | Aqueous Based Buffer |
| Type of Analytes | 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. | Amylase, Calcium, Glucose, Chloride, Creatinine, Magnesium, Potassium, Sodium, Microprotein, Microalbumin, Phosphorous, Urea Nitrogen, Uric Acid. |
| Form | Lyophilized | Lyophilized |
| Storage | 2 to 8° C Until expiration date | 2 to 8° C Until expiration date |
| Reconstituted Stability | 1 day at 2 to 8° C | Set 1: 72 hours at 2 to 8° C Set 2: 10 days at 2 to 8° C |
| Shelf Life | Demonstrated by predicate. | One year, when stored unopened at 2 - 8º C. (Real-time studies ongoing). |
Note: The acceptance criteria for the new device are implicitly met by demonstrating substantial equivalence to the predicate device. The performance data provided are the reported characteristics of the new device itself, which are compared to those of the predicate. The key "proof" is that these characteristics are considered acceptable, given the similarity to the predicate, even if the new device has different analytes or matrix type (which is discussed in the context of substantial equivalence).
2. Sample Size Used for the Test Set and Data Provenance
The document states: "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."
- Sample Size: Not explicitly stated in the provided text.
- Data Provenance: The studies were conducted by Aalto Scientific, Ltd. (the manufacturer). The text does not specify the country of origin for the data or whether it was retrospective or prospective, though "real time studies are ongoing" for shelf life, indicating a prospective component for that aspect.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is generally not applicable to the validation of a chemistry linearity quality control material. The "ground truth" for linearity sets is established through analytical methods and statistical analysis, not expert interpretation of images or patient data. The manufacturer would establish the expected linear relationship of the analyte concentrations within the different levels of the control material through precise preparation and analytical testing.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving expert review of ambiguous data (e.g., medical images) to establish a consensus ground truth. For a chemistry linearity control, the "ground truth" is determined by the meticulously prepared concentrations and subsequent analytical measurements.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. This device is a quality control material for chemistry analyzers, not an AI-powered diagnostic tool requiring human interpretation. Therefore, MRMC studies and the concept of AI assistance for human readers are irrelevant in this context.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an algorithm or an AI product. It is a physical chemical solution used to calibrate and verify the linearity of laboratory instruments.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device is the analytically determined concentrations and the designed linear relationship among the different levels of the control material. The manufacturer would have precisely formulated each level to have specific, known concentrations of the analytes, creating an expected linear progression. The performance study verifies that both the stability and the linearity of these known concentrations are maintained over time and storage conditions with analytical testing.
8. The Sample Size for the Training Set
Not applicable. As a quality control material, there is no "training set" in the context of machine learning or AI. The product is manufactured to a specific formulation and then tested to demonstrate its characteristics.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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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 ChemistryLinearity Set(K111964) | Audit™ MicroCV™ General ChemistryLinearity Set(K042318) |
|---|---|---|
| Intended Use | The Audit™ MicroCV™ Urine/Fluids ChemistryLinearity Set is assayed quality control materialconsisting of two sets of five levels of aqueousbuffer. Each level of Set 1 contains the followinganalytes: Phosphorous, Urea Nitrogen, UricAcid. Each level of Set 2 contains the followinganalytes: Amylase, Calcium, Glucose, Chloride,Creatinine, Magnesium, Potassium, Sodium,Microprotein, Microalbumin. These five levels ofeach set demonstrate a linear relationship toeach other for their respective analytes,reagents and instruments.The product is intended for use with quantitativeassays on the indicated analyzer specified inthe labeling. When used for quality controlpurposes, it is recommended that eachlaboratory establish its own means andacceptable ranges and use the values providedonly as guides. The Audit™ MicroCV™Urine/Fluids Chemistry Linearity Set is "For InVitro Diagnostic Use Only". | Audit® MicroCV™ General Chemistry LinearitySet consists of five levels of human basedserum. Each level contains the followinganalytes: Albumin, Alkaline Phosphatase, ALT,Amylase, AST, Bilirubin (Total and Direct), BUN,Calcium, Chloride, Cholesterol, CO2, CreatineKinase, Creatinine, Gamma-GT, LDH, Glucose,HDL Cholesterol, Iron, Lactate, LDLCholesterol, Lipase, Magnesium, Phosphorus,Potassium, Sodium, Total Protein, Triglyceridesand Uric Acid. These five levels demonstrate alinear relationship to each other for theirrespective analytes, reagents and instruments¹ |
| Number ofAnalytes per vial | Set 13 | Set 230 |
| Number oflevels 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, UreaNitrogen 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° CUntil expiration date | 2 to 8° CUntil expiration date |
| ReconstitutedStability | 72 hours at 2 to 8° C for Set 110 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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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
§ 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.