(28 days)
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No
The document describes a quality control material for urinalysis and does not mention any AI or ML components in its description, intended use, or performance studies.
No
The device is a quality control material used to monitor the precision of urinalysis test procedures, not to treat or diagnose a medical condition.
No
Explanation: The device is a quality control material used to monitor the precision of urinalysis test procedures, not to diagnose a condition or disease in a patient.
No
The device description clearly states it is a liquid control material prepared from human urine and other biological/chemical components, indicating it is a physical substance, not software.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "monitoring the precision of urinalysis test procedures for the analytes listed in the package insert." This is a classic function of an IVD control material, used to verify the performance of diagnostic tests performed in vitro (outside the body).
- Device Description: The description details the composition of the control material, which is designed to mimic human urine and contains various components relevant to urinalysis testing.
- Predicate Device: The mention of a predicate device (K031231; Liquichek™ Urinalysis Control) further confirms its classification as an IVD, as predicate devices are used to demonstrate substantial equivalence for regulatory purposes within the IVD framework.
While the document doesn't contain information about image processing, AI/ML, or patient details, the core function and description align with the definition of an IVD.
N/A
Intended Use / Indications for Use
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 this package insert.
Product codes
JJW
Device Description
Liquichek Urinalysis Control is prepared from human urine with added human erythrocytes, simulated leukocytes, constituents of animal origin, pure chemicals, preservatives and stabilizers. The control is provided in liquid form for convenience.
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
Stability studies have been performed to determine the open vial stability and shelf life for the Liquichek Urinalysis Control. Product claims are as follows:
- Qpen vial: Once the control is opened and stored tightly capped, all analytes will be stable 7.1 for 30 days at room temperature (18 to 25°C).
- 7.2 Shelf Life: 30 months when stored at 2 to 8°C.
Real time studies will be ongoing to support the shelf life of this product.
All supporting data is retained on file at Bio-Rad Laboratories.
Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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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Summary of Safety and Effectiveness Liquichek™ Urinalysis Control
APR 2 5 2007
1.0 Submitter
Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 Telephone: (949) 598-1200 Fax: (949) 598-1557
Contact Person
Suzanne Parsons Regulatory Affairs Specialist Telephone: (949) 598-1467
Date of Summary Preparation
March 26, 2007
2.0 Device Identification
| Product Trade Name: | Liquichek Urinalysis Control |
|---|---|
| Common Name: | Urinalysis controls (Assayed and Unassayed) |
| Classifications: | Class I |
| Product Code: | JJW |
| Regulation Number: | CFR 862.1660 |
3.0 Device to Which Substantial Equivalence is Claimed
Liquichek™ Urinalysis Control Bio-Rad Laboratories Irvine, California
Docket Number: K031231
4.0 Description of Device
Liquichek Urinalysis Control is prepared from human urine with added human erythrocytes, simulated leukocytes, constituents of animal origin, pure chemicals, preservatives and stabilizers. The control is provided in liquid form for convenience.
5.0 Statement of Intended Use
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 this package insert.
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6.0 Comparison of the new device with the Predicate Device
The new Liquichek Urinalysis Control claims substantial equivalence to the Liquichek Urinalysis Control currently in commercial distribution (K031231).
Liquichek Urinalysis Control claims substantial equivalence to the Liquichek Urinalysis Control currently in commercial distribution (K031231). Both of these controls are manufactured with exactly the same formulation. The only difference between the predicate device and the new Liquichek Urinalysis Control is that new product has claims for color and clarity and the predicate device does not.
| Characteristics | Bio-Rad
Liquichek™ Urinalysis Control
(New Device) | Bio-Rad
Liquichek™ Urinalysis Control
(Predicate Device) |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | 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 this package insert. | Liquichek™ Urinalysis Control is intended for
use as an assayed quality control urine to monitor the precision of laboratory dipstick and microscopic testing procedures for analytes listed in this package insert. |
| Form | Liquid | Liquid |
| Matrix | Urine | Urine |
| Storage | 2°C to 8°C
Until expiration date | 2°C to 8°C
Until expiration date |
| Open Vial | 30 days at room temperature (18-25° C) | 30 days at room temperature (18-25° C) |
| Preservatives | 5-chloro-2-methyl-2H-isothiazol-3-one | 5-chloro-2-methyl-2H-isothiazol-3-one |
| Squeezer Caps | Approved for Use | Approved for Use |
| Differences | | |
| Analytes | Same analytes as the predicate device
with the additional claims for color and
clarity. | Does not have claims for color and clarity |
7.0 Statement of Supporting Data
Stability studies have been performed to determine the open vial stability and shelf life for the Liquichek Urinalysis Control. Product claims are as follows:
- Qpen vial: Once the control is opened and stored tightly capped, all analytes will be stable 7.1 for 30 days at room temperature (18 to 25°C).
- 7.2 Shelf Life: 30 months when stored at 2 to 8°C.
Real time studies will be ongoing to support the shelf life of this product.
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 stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is depicted in black, and the text is also in black.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Bio-Rad Laboratories c/o Ms. Suzanne Parsons Regulatory Affairs Representative 9500 Jeronimo Road Irvine, California 92618-2017
APR 2 5 2007
Re: K070848 Trade/Device Name: Liquichek™M Urinalysis Control Regulation Number: 21 CFR 862.1660 Quality control material (assayed and unassayed) Regulation Name: Regulatory Class: Class I Product Code: JJW Dated: March 26, 2007 Received: March 28, 2007
Dear Ms. Parsons:
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 (240) 276-0490. 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Coopes, M.S., D.V.M.
Yean M. Cooper, M.S., 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
510(k) Number (if known):
Device Name:
Indications For Use:
K070848 Liquichek™ Urinalysis Control
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.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
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
Office of In Vitro Diagnostic
Device Evaluation and Safety
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510(k) K070848