(54 days)
Not Found
No
The summary describes a liquid quality control solution for urinalysis and does not mention any computational or analytical capabilities that would suggest the use of AI or ML.
No
The device is described as an assayed quality control intended to monitor the precision of urinalysis test procedures. It is used to evaluate the performance of diagnostic tests, not to treat, mitigate, or prevent disease in a patient.
No
Explanation: This device is described as an assayed quality control for monitoring the precision of urinalysis test procedures, not for diagnosing diseases or conditions in patients.
No
The device description explicitly states it is a "liquid matrix solution" and lists physical components like human erythrocytes, leukocytes, animal constituents, chemicals, and preservatives, indicating it is a physical product, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that it is a "quality control to monitor the precision of urinalysis test procedures." Urinalysis is a laboratory test performed on a sample of urine, which is an in vitro sample.
- Device Description: The device is a "liquid matrix solution prepared with human erythrocytes and [leukocytes in qUAntify Plus only], constituents of animal origin, chemicals, and preservatives." This describes a reagent or control material used in laboratory testing.
- Predicate Device: The mention of a predicate device (K031231; Liquichek™ Urinalysis Control) which is also a urinalysis control, further supports its classification as an IVD. Predicate devices are used in regulatory submissions for new IVDs.
Therefore, based on the provided information, the qUAntify® Control and qUAntify® Plus Control are clearly intended for use in laboratory testing of in vitro samples (urine) to monitor the performance of those tests, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
qUAntify 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.
Product codes (comma separated list FDA assigned to the subject device)
JJW
Device Description
These products are a liquid matrix solution prepared with human erythrocytes and [leukocytes in qUAntify Plus only], constituents of animal origin, chemicals, and preservatives.
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 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.
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.
0
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 quality | ||
| control to monitor the precision of urinalysis test procedures for the analytes listed in | |||
| this package insert. | Liquichek Urinalysis Control is intended for use as an | ||
| assayed quality control urine to monitor the precision of | |||
| urinalysis test procedures for the analytes listed in the | |||
| package 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 room | |
| temperature (18-25° C) | |||
| Analytes | qUAntify Control contains the | ||
| following analytes: | qUAntify Plus Control contains the | ||
| following analytes: | Contains the following analytes: | ||
| Albumin | |||
| Albumin-to-Creatinine Ratio | |||
| Ascorbic Acid | |||
| Bilirubin | |||
| Blood | |||
| Creatinine | |||
| Glucose | |||
| hCG | |||
| Hemoglobin | |||
| Ketones | |||
| Leukocytes | |||
| Nitrite | |||
| Microalbumin | |||
| Protein-to-Creatinine Ratio | |||
| Protein, Total | |||
| pH | |||
| Urobilinogen | |||
| Specific Gravity | Albumin | ||
| Albumin-to-Creatinine Ratio | |||
| Ascorbic Acid | |||
| Bilirubin | |||
| Blood | |||
| Crystals | |||
| Casts | |||
| Creatinine | |||
| Glucose | |||
| hCG | |||
| Hemoglobin | |||
| Ketones | |||
| Leukocytes | |||
| Microalbumin | |||
| Nitrite | |||
| Protein-to-Creatinine Ratio | |||
| Protein, Total | |||
| pH | |||
| Urobilinogen | |||
| Red Blood Cells (RBC) | |||
| Specific Gravity | |||
| White Blood Cells (WBC) | Bilirubin | ||
| Blood | |||
| Creatinine | |||
| Glucose | |||
| hCG (also described as Pregnancy) | |||
| Ketones | |||
| Microalbumin | |||
| Leukocytes | |||
| Nitrite | |||
| Protein-to-Creatinine Ratio | |||
| Protein, Total | |||
| pH | |||
| Urobilinogen | |||
| Red Blood Cells (RBC) | |||
| White Blood Cells (WBC) | |||
| Crystals | |||
| Casts | |||
| Osmolality | |||
| Specific Gravity | |||
| Does not contain: | |||
| Osmolality | |||
| Red Blood Cells (RBC) | |||
| White Blood Cells (WBC) | |||
| Crystals | |||
| Casts | Does not contain: | ||
| Osmolality | Does not contain: | ||
| Albumin | |||
| Albumin-to-Creatinine Ratio | |||
| Ascorbic Acid | |||
| Hemoglobin |
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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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
4
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
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