(54 days)
qUAntify® Control is intended for use as an assayed quality control to monitor the precision of urinalysis test procedures for the analytes listed in the package insert. qUAntify® Plus Control is intended for use as an assayed quality control to monitor the precision of urinalysis test procedures for the analytes listed in the package insert.
These products are a liquid matrix solution prepared with human erythrocytes and [leukocytes in qUAntify Plus only], constituents of animal origin, chemicals, and preservatives.
The provided text describes the Bio-Rad Laboratories qUAntify Control and qUAntify Plus Control devices, which are urinalysis controls. It details their intended use, composition, and makes a claim of substantial equivalence to a predicate device, the Liquichek™ Urinalysis Control (K031231). The acceptance criteria are implied through the comparison of characteristics and the stability studies performed.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document describes the performance of the new device relative to its predicate and its stability. The "acceptance criteria" are implied by the claims made for the new device, particularly in comparison to the predicate device and the results of the stability studies.
| Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Intended Use | Monitor precision of urinalysis test procedures. | Met: "intended for use as an assayed quality control to monitor the precision of urinalysis test procedures" |
| Form | Liquid | Met: "Liquid matrix solution" |
| Storage Stability | 2°C to 8°C Until expiration date | Met: "2°C to 8°C Until expiration date" |
| Open Vial Stability | Comparable to predicate (30 days at 2-8°C or 7 days at room temp) | Exceeded: "31 days at 2 to 8°C or room temperature (18 to 25°C)" |
| Shelf Life | Not explicitly stated for predicate in comparison table, but typically long | Met: "Two years at 2 to 8 °C" |
| Matrix | Human urine for predicate | Different: "Liquid matrix solution prepared with human erythrocytes and [leukocytes in qUAntify Plus only], constituents of animal origin, chemicals, and preservatives." The substantial equivalence claim suggests this difference is acceptable. |
| Analytes | Comparable analytes for urinalysis control | Broad range of analytes, largely overlapping with and in some cases expanding upon the predicate. Differences are noted but within the scope of intended use. (See full list in "Differences" section of Table 1) |
The study that proves the device meets the acceptance criteria is referred to as "Stability studies."
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Stability studies have been performed to determine the open vial stability and shelf life for the qUAntify Control and qUAntify Plus Control." However, it does not specify the sample size used for these stability studies or the data provenance (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The controls are intended for monitoring the precision of urinalysis test procedures, and the "ground truth" would likely refer to the established, expected values for the analytes within the control materials. The document doesn't describe the process of establishing these expected values or if experts were involved in the testing for the purposes of this submission beyond the internal Bio-Rad personnel mentioned (e.g., Regulatory Affairs Specialist).
4. Adjudication Method for the Test Set
The document does not specify any adjudication method used for the stability studies or for establishing the expected values of the control materials.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The device described is a quality control material, not an imaging or diagnostic device that would typically involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable in the conventional sense. This device is a quality control material used to assess the precision of urinalysis test procedures, which are typically performed by laboratory instruments or manual methods, and then interpreted by laboratory personnel. It is not an algorithm or an AI-driven device.
7. The Type of Ground Truth Used
The ground truth for a quality control material typically consists of established target values and acceptable ranges for each analyte within the control. These values are determined through extensive testing using reference methods and/or multiple clinical instruments. The document implicitly relies on this type of ground truth for its stated intended use to "monitor the precision of urinalysis test procedures."
8. The Sample Size for the Training Set
This information is not applicable/not provided. Quality control materials do not typically have "training sets" in the context of machine learning or diagnostic algorithm development. The development process involves formulation, characterization, and stability testing.
9. How the Ground Truth for the Training Set was Established
This information is not applicable/not provided for the same reasons as #8.
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K04 2446
NOV - 2 2004
Summary of Safety and Effectiveness qUAntify Control and qUAntify Plus Control
1.0 Submitter
Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 (949) 598-1200 Telephone: (949) 598-1557 Fax:
Contact Person
Maria Zeballos Regulatory Affairs Specialist (949) 598-1367 Telephone:
Date of Summary Preparation
September 3, 2004
2.0 Device Identification
| Product Trade Name: | qUAntify Control and qUAntify Plus Control |
|---|---|
| Common Name: | Urinalysis controls (Assayed and Unassayed) |
| Classifications: | Class I |
| Product Code: | JJW |
| Regulation Number: | 21 CFR 862.1660 |
3.0 Device to Which Substantial Equivalence is Claimed
Liquichek™ Urinalysis Control Bio-Rad Laboratories Irvine, California
510 (k) Number: K031231
4.0 Description of Device
These products are a liquid matrix solution prepared with human erythrocytes and [leukocytes in qUAntify Plus only], constituents of animal origin, chemicals, and preservatives.
5.0 Intended Use
gUAntify Control and qUAntify Plus Control are intended for use as an assayed quality control to monitor the precision of urinalysis test procedures listed in their respective package inserts.
6.0 Preservatives:
qUAntify Control and qUAntify Plus Control contain preservatives in a concentration of less than 0.1%. At this low level, the ingredients are not expected to cause a health hazard to the user. And thus, domestic and international regulations do not require this type of information on the vial or box label.
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Comparison of the new device with the Predicate Device 7.0
gUAntify Control and qUAntify Plus Control claim substantial equivalence to the Liquichek Urinalysis Control currently in commercial distribution (K031231).
| Bio-Rad Laboratories | Bio-Rad Laboratories | ||
|---|---|---|---|
| qUAntify Control and qUAntify Plus Control | Liquichek™ Urinalysis Control | ||
| Characteristics(New Device) | (Predicate Device -K031231) | ||
| Similarities | |||
| Intended Use | [qUAntify Control ] [qUAntify Plus Control] is intended for use as an assayed qualitycontrol to monitor the precision of urinalysis test procedures for the analytes listed inthis package insert. | Liquichek Urinalysis Control is intended for use as anassayed quality control urine to monitor the precision ofurinalysis test procedures for the analytes listed in thepackage insert. | |
| Form | Liquid | Liquid | |
| Storage Stability | 2°C to 8°C Until expiration date | 2°C to 8°C Until expiration date | |
| Differences | |||
| Matrix | Liquid matrix solution | Human Urine | |
| Open Vial | 31 days at 2 to 8°C or room temperature (18 to 25°C) | 30 days at 2 to 8° C or 7 days at roomtemperature (18-25° C) | |
| Analytes | qUAntify Control contains thefollowing analytes: | qUAntify Plus Control contains thefollowing analytes: | Contains the following analytes: |
| AlbuminAlbumin-to-Creatinine RatioAscorbic AcidBilirubinBloodCreatinineGlucosehCGHemoglobinKetonesLeukocytesNitriteMicroalbuminProtein-to-Creatinine RatioProtein, TotalpHUrobilinogenSpecific Gravity | AlbuminAlbumin-to-Creatinine RatioAscorbic AcidBilirubinBloodCrystalsCastsCreatinineGlucosehCGHemoglobinKetonesLeukocytesMicroalbuminNitriteProtein-to-Creatinine RatioProtein, TotalpHUrobilinogenRed Blood Cells (RBC)Specific GravityWhite Blood Cells (WBC) | BilirubinBloodCreatinineGlucosehCG (also described as Pregnancy)KetonesMicroalbuminLeukocytesNitriteProtein-to-Creatinine RatioProtein, TotalpHUrobilinogenRed Blood Cells (RBC)White Blood Cells (WBC)CrystalsCastsOsmolalitySpecific Gravity | |
| Does not contain:OsmolalityRed Blood Cells (RBC)White Blood Cells (WBC)CrystalsCasts | Does not contain:Osmolality | Does not contain:AlbuminAlbumin-to-Creatinine RatioAscorbic AcidHemoglobin |
Table 1. Similarities and Differences between new and predicate device.
8.0 Statement of Supporting Data
Stability studies have been performed to determine the open vial stability and shelf life for the qUAntify Control and qUAntify Plus Control. Product claims are as follows:
- Open vial Stability: 31 days at 2 to 8°C or room temperature (18 to 25°C) . .
- Shelf Life: Two years at 2 to 8 °C
All supporting data is retained on file at Bio-Rad Laboratories.
.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings outstretched, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV - 2 2004
Ms. Elizabeth Platt Regulatory Affairs Manager/ Quality Assurance Bio-Rad Laboratories, QSD 9500 Jeronimo Road Irvine, CA 92618
K042446 Re: Trade/Device Name: qUAntify® Control qUAntify® Plus Control Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassyed) Regulatory Class: Class I Product Code: JJW Dated: September 3, 2004 Received: September 9, 2004
Dear Ms. Platt:
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 either class II (Special Controls) or class III (PMA), 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 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2
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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Jean M. Cooper, U.S., DVM.
Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
K042446 510(k) Number (if known): qUAntify® Control Device Name: qUAntify® Control is intended for use as an assayed quality control to Indications For Use: monitor the precision of urinalysis test procedures for the analytes listed in the package insert. qUAntify® Plus Control Device Name: gUAntify® Plus Control is intended for use as an assayed quality control Indications For Use: to monitor the precision of urinalysis test procedures for the analytes
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
listed in the package insert.
Over-The-Counter Use (21 CFR 807 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)
Carol C. Benson
Division Sign-Off
of In Vitro Diagnostic
510(k) K042446
Page 1 of
§ 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.