(30 days)
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No
The document describes a quality control material for laboratory procedures and does not mention any AI or ML components.
No
Explanation: The device is described as an "assayed quality control urine to monitor the precision of laboratory procedures," not for diagnosing, treating, or preventing disease.
No
Explanation: The device is a quality control material used to monitor the precision of laboratory procedures, not to diagnose a patient's condition.
No
The device description clearly states it is a liquid control material prepared from human urine and other constituents, indicating it is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "monitoring the precision of laboratory procedures listed in the package insert." This indicates it's used in a laboratory setting to assess the performance of diagnostic tests.
- Device Description: It's a "quality control urine" prepared from biological materials (human urine, human and animal origin constituents) and chemicals. This type of material is specifically designed for use in in vitro diagnostic testing.
- Care Setting: The intended user is described as performing "laboratory procedures," which is the typical setting for IVD use.
While it doesn't directly diagnose a disease, it's a crucial component in ensuring the accuracy and reliability of diagnostic tests performed in vitro. Quality control materials like this are considered IVDs because they are used with diagnostic tests to ensure they are functioning correctly.
N/A
Intended Use / Indications for Use
Liquichek™ Urine Chemistry Control is intended for use as an assayed quality control urine to monitor the precision of laboratory procedures listed in the package insert.
Product codes (comma separated list FDA assigned to the subject device)
JJY
Device Description
Liquichek™ Urine Chemistry Control is prepared from human urine with added constituents of human and 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 (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 Liquichek™ Urine Chemistry Control. Product claims are as follows:
- Open vial: Once the control material is opened, all analytes will be stable for 30 days when stored tightly capped at 2-8°C.
- Shelf Life: One year and six months when stored at 2-8 ℃.
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 (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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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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APR 1 2 2002
Page 1 of 2
Bio-Rad Laboratories Premarket Notification Section 510(k) for Liquichek™ Urine Chemistry Control Summary of Safety and Effectiveness
Summary of Safety and Effectiveness Liquichek™ Urine Chemistry Control
1.0 Submitter
Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 Telephone: (949) 598-1200 (949) 598-1555 Fax:
Contact Person
Maria Zeballos Regulatory Affairs Specialist Telephone: (949) 598-1367
Date of Summary Preparation
March 11. 2002
2.0 Device Identification
Product Trade Name: | Liquichek™ Urine Chemistry Control |
---|---|
Common Name: | Multi-Analyte Controls, (Assayed and unassayed) |
Classifications: | Class I |
Product Code: | JJY |
Regulation Number: | 21 CFR 862.1660 |
3.0 Device to Which Substantial Equivalence is Claimed
Liquichek™ Urine Chemistry Control Bio-Rad Laboratories Irvine, California
Docket Number: K971954
4.0 Description of Device
Liquichek™ Urine Chemistry Control is prepared from human urine with added constituents of human and animal origin, pure chemicals, preservatives and stabilizers. The control is provided in liquid form for convenience.
5.0 Statement of Intended Use
Liguichek™ Urine Chemistry Control is intended for use as an assayed quality control urine to monitor the precision of laboratory procedures listed in the package insert.
1
Comparison of the new device with the Predicate Device 6.0
Liquichek™ Urine Chemistry Control claims substantial equivalence to the Liquichek™ Urine Chemistry Control levels currently in commercial distribution (K971954). The new Liquichek™ Urine Chemistry Control contains Cortisol and the current product does not.
| Characteristics | Bio-Rad
Liquichek™ Urine Chemistry Control
(New Device) | Bio-Rad
Liquichek™ Urine Chemistry Control
(Predicate Device) |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | Liquichek™ Urine Chemistry Control is
intended for use as assayed quality control
urine to monitor the precision of laboratory
testing procedures for analytes listed in the
package insert. | Liquichek™ Urine Chemistry Control is
intended for use as assayed quality control
urine to monitor the precision of laboratory
testing procedures for analytes listed in the
package insert. |
| Form | Liquid | Liquid |
| Matrix | Human urine based | Human urine based |
| Storage
(Unopened) | 2 to 8°C
Until expiration date | 2 to 8°C
Until expiration date |
| Open Vial Claim | 30 days at 2-8°C | 30 days at 2-8°C |
| Differences | | |
| Analytes | Contains: Amylase, Calcium, Chloride,
Cortisol, Creatinine, Glucose, Magnesium,
Microalbumin, Osmolality, pH, Phosphorus,
Potassium, Pregnancy, Protein- Total,
Sodium, Specific Gravity, Urea, Urea
Nitrogen, Uric Acid. | Contains: Amylase, Calcium, Chloride,
Creatinine, Glucose, Magnesium,
Microalbumin, Osmolality, pH, Phosphorus,
Potassium, Pregnancy, Protein- Total,
Sodium, Specific Gravity, Urea, Urea
Nitrogen, Uric Acid.
Does not Contain: Cortisol |
Table 1. Similarities and Differences between new and predicate device.
7.0 Summary of Performance Data
Stability studies have been performed to determine the open vial stability and shelf life for the Liquichek™ Urine Chemistry Control. Product claims are as follows:
- Open vial: Once the control material is opened, all analytes will be stable for 30 7.1 days when stored tightly capped at 2-8°C.
- Shelf Life: One year and six months when stored at 2-8 ℃. 7.2
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.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the symbol. The text is in all caps and is evenly spaced around the circle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Elizabeth Platt Regulatory Affairs/Quality Assurance Manager Bio-Rad Laboratories, QSD 9500 Jeronimo Road Irvine, CA 92618-2017
APR 1 2 2002
Re: K020817
Trade/Device Name: Liquichek™ Urine Chemistry Control Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I reserved Product Code: JJY Dated: March 11, 2002 Received: March 13, 2002
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 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 Part 801); 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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Page 2 - -
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or 11analatotal 610 or at its internet address "http://www.fda.gov/cdrb/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510 (k) Number (if known):____________________________________________________________________________________________________________________________________________________
Device Name: Liquichek™ Urine Chemistry Control
Indications for Use:
Liquichek™ Urine Chemistry Control is intended as an assayed quality control urine to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
Sean Conroy
Division Sign-Off) Division of Clinical Laboratory Devices 120817 510(k) Number --
(PLEASE DO NOT WRITE BELOW THE LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription use______________________________________________________________________________________________________________________________________________________________ or
Over-the Counter use_