(239 days)
Not Found
No
The device is a quality control material for urine test strips and analyzers, with no mention of AI/ML in the description or performance studies.
No.
The device is a quality control material intended for in vitro diagnostic use, specifically for performing quality control procedures with urine test strips and analyzers. It is not used for treating any medical condition.
No
Explanation: The AUTION CHECK Plus is described as a "quality control material" for in vitro diagnostic use, meaning it is used to check the performance of other diagnostic tests (urine test strips and analyzers), not to directly diagnose a condition in a patient.
No
The device is a liquid quality control material, which is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"The AUTION CHECK Plus is a quality control material intended for in vitro diagnostic use only..."
This statement clearly indicates that the device is intended to be used outside of the body for diagnostic purposes, which is the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The AUTION CHECK Plus is a quality control material intended for in vitro diagnostic use only, for performing quality control procedures with Arkray urine test strips and analyzers.
Product codes
JJW
Device Description
The AUTION CHECK Plus, is a two level liquid control prepared from human urine source material with added stabilizers and preservatives. Level 1 is positive for bilirubin and urobilinogen and Level 2 is positive for glucose, protein, blood, ketone, nitrite and leukocytes.
The urine donors are screened for HBs antigen , HCV, HIV1, and HIV2, and found to be negative by US FDA accepted methods. human source material used to manufacture this control was tested by FDA accepted methods
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)
Accelerated stability studies were conducted to establish the open and unopened stability claims. Accelerated stability studies were conducted to establish the shelf-life stability claim. Acceptance criteria were met to support the product claims as follows:
Real time stability studies are ongoing and performed for every lot.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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 logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 9, 2015
QUANTIMETRIX CORP. KALYNA SNYLYK 2005 MANHATTAN BEACH BLVD. REDONDO BEACH CA 90278-1205
Re: K142262
Trade/Device Name: AUTION CHECK Plus Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (assayed and unassayed) Regulatory Class: I, reserved Product Code: JJW Dated: March 09, 2015 Received: March 09, 2015
Dear Kalyna Snylyk:
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.
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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,
Stayce Beck -S
For: 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
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K142262
Device Name AUTION CHECK Plus
Indications for Use (Describe)
The AUTION CHECK Plus is a quality control material intended for in vitro diagnostic use only, for performing quality control procedures with Arkray urine test strips and analyzers.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed announg the and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Image /page/3/Picture/0 description: The image shows the word "Quantimetrix" in a bold, sans-serif font. To the left of the word is a logo consisting of two interlocking circles. The logo and the word are both in black, and the background is white.
510(k) Summary AUTION CHECK Plus (K142262)
Submitter:
Quantimetrix Corporation 2005 Manhattan Beach Blvd. Redondo Beach, CA 90278
Contact person:
Kalyna Snylyk Director Regulatory Affairs and Quality Assurance Telephone: (310) 536-0006 Fax: (310) 536-9977
Date Summary prepared:
April 10th, 2015
Device identification:
Product Trade name: AUTION CHECK Plus Common name: Urinalysis Controls, (Assayed) Clinical Chemistry and Clinical Toxicology Devices Review Panel: Classifications: Class I, reserved Product code: JJW Regulation number: 21 CFR 862.1660
Device to which substantial equivalence is claimed
Dropper Urine Dipstick Control Ouantimetrix Corporation Redondo Beach, CA 90278
510(k) number K874890
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Image /page/4/Picture/0 description: The image shows the word "Quantimetrix" in a bold, sans-serif font. To the left of the word is a symbol that looks like two interlocking letter C's. The symbol and the word are both in black, and the background is white. The image is a logo for the company Quantimetrix.
Description of Device
The AUTION CHECK Plus, is a two level liquid control prepared from human urine source material with added stabilizers and preservatives. Level 1 is positive for bilirubin and urobilinogen and Level 2 is positive for glucose, protein, blood, ketone, nitrite and leukocytes.
The urine donors are screened for HBs antigen , HCV, HIV1, and HIV2, and found to be negative by US FDA accepted methods. human source material used to manufacture this control was tested by FDA accepted methods
Value Assignment
The value assignment of each lot of AUTION CHECK Plus control is confirmed by laboratory analysis prior to release. Value assignment confirmation is performed by the Quality Control group in the laboratories of Quantimetrix Corporation. The testing is performed by three different operators using three different Arkray urinalysis analyzers. Each operator and analyzer performs a total of four tests on the control product. For each of the operators and analyzers, the mean of these four test results is then calculated. The means from all three operators and analyzers must fall within the specification range for the lot to be released.
Intended use
The AUTION™ CHECK Plus is a quality control material intended for in vitro diagnostic use only, for performing quality control procedures with Arkray urine test strips and analyzers.
Comparison of the new device with the Predicate Device
The new AUTION CHECK Plus claims substantial equivalence to the Dropper Urine Dipstick Control currently in commercial distribution (K874890). Table 1 (below) contains comparison information of similarities and differences between the new and predicate device to which substantial equivalence is claimed.
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Image /page/5/Picture/0 description: The image shows the word "Quantimetrix" in a sans-serif font, with a stylized logo to the left. The logo consists of two interlocking shapes that resemble the letter "C". The text is in black and the background is white.
Table 1: Similarities and Differences between new and predicate device:
| Characteristics | AUTION CHECK Plus
(New device) | Dropper Urine Dipstick Control
(Predicate Device K874890) |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | Same | Is intended as a control for urinalysis
reagent strips and analyzers. |
| Vial | Same | Twenty Five mL plastic squeezable
bottle with dropper tip. |
| Kit | Same | Each kit contains package insert
instructions and 4 x 25 mL Control
bottles, 2 Level 1 and 2 Level 2. |
| Storage Condition | Same | Refrigerated (2-8°C) |
| Testing Procedure | Same | Remove the control from the refrigerator and leave it the temperature of 18-25°C for at least 15 minutes Mix by Inversion Return to the refrigerator upon completion of testing |
| Form | Same | Liquid |
| Matrix | Same | Human Urine |
| Closed Vial Shelf Life | Same | At 2-8° C until the expiration date of
18 months |
| Differences | | |
| Storage and Stability | Open Vial Stability
Once opened, AUTION CHECK Plus
can be used for 30 days as long as the
unopened expiration date has not passed. | Open Vial Stability
When stored at 2-8°C the opened Urine
Dipstick Control bottles are stable until
the expiration date stated on the label. |
| Testing Procedure | Dispensing of the Control
Dispense the required volume of control
into a sample tube. Wipe the tip of the
control bottle and cap the bottle after
dispensing. | Dispensing of the Control
Remove cap and invert bottle. While
holding dipstick, gently squeeze the
sides of the dropper bottle, and touch the
tip of the bottle to the dipstick. Draw
across all of the reagent pads,
thoroughly saturating each pad. |
| Analyte(s) | Glucose, Protein, Bilirubin,
Urobilinogen, pH, Blood, Ketone,
Nitrite, Leukocytes, Specific Gravity | Glucose, Protein, Bilirubin,
Urobilinogen, pH, Blood, Ketone,
Nitrite, Leukocytes, Specific Gravity,
Albumin, Creatinine, hCG |
| Intended Use | Arkray does not make confirmatory tests
so results are not included in the package
insert. | Can be used as a control for
confirmatory tests such as Acetest,®
Clinitest,® and Ictotest® reagent
tablets, and for hCG methods. |
| Open vial Stability: | 30 days at 2 to 8°C | |
| Closed vial Stability: | 18 months at 2 to 8°C | |
| Shelf life Stability: | 18 months at 2 to 8°C | |
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Image /page/6/Picture/0 description: The image shows the logo for Quantimetrix. The logo consists of two interlocking circles on the left, followed by the word "Quantimetrix" in a bold, sans-serif font. The interlocking circles are a stylized design element, and the text is clear and legible.
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Image /page/7/Picture/0 description: The image shows the logo for Quantimetrix. The logo consists of two interlocking circles on the left, followed by the word "Quantimetrix" in a sans-serif font. The logo is black and white.
Statement of Supporting Data:
Accelerated stability studies were conducted to establish the open and unopened stability claims. Accelerated stability studies were conducted to establish the shelf-life stability claim. Acceptance criteria were met to support the product claims as follows:
Real time stability studies are ongoing and performed for every lot.
Conclusion:
Based on the performance characteristics indicated above, the Aution Check Plus is substantially equivalent to the predicate device Dropper Urine Dipstick Control, reference 510(k) K874890