(22 days)
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No
The document describes a quality control material for laboratory testing and does not mention any AI or ML components.
No
The device is a quality control urine used to monitor the precision of laboratory testing procedures, not to treat or diagnose patients.
No.
The device is a quality control material used to monitor the precision of laboratory testing procedures, not to diagnose a patient's condition.
No
The device is a liquid quality control material, not a software application. It is a physical substance used to monitor the precision of laboratory tests.
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 testing procedures for the analytes listed in the package insert." This indicates it's used in vitro (outside the body) to assess the performance of diagnostic tests.
- Device Description: The description mentions it's prepared from human urine with added constituents, chemicals, preservatives, and stabilizers. This is consistent with the composition of a control material used in laboratory testing.
- Intended User/Care Setting: It's intended for "laboratory testing procedures," which is the typical setting for IVD use.
- Predicate Device: The mention of a predicate device (K020817; Liquichek Urine Chemistry Control) further confirms its classification as an IVD, as predicate devices are used to demonstrate substantial equivalence for new IVDs.
While it doesn't directly diagnose a disease, it's a crucial component in ensuring the accuracy and reliability of diagnostic tests performed in a laboratory setting, which falls under the scope of IVDs.
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 testing procedures for the analytes 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, 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 for Liquichek Urine Chemistry control to determine the open vial and shelf life claims.
Open Vial: 30 days at 2 to 8°C.
Shelf Life Stability: 24 Months at 2°C to 8°C.
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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Bio-Rad Laboratories Premarket Notification Section 510 (k) Liquichek Urine Chemistry Control
Summary of Safety and Effectiveness Liquichek Urine Chemistry Control
1.0 Submitter
Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, Callfornia 92618-2017 Telephone: (949) 598-1200 (949) 598-1557 Fax:
Contact Person
Suzanne Parsons Regulatory Affairs Manager Telephone: (949) 598-1467
Date of Summary Preparation
June 15th, 2012
2.0 Device Identification
| Product Trade Name: | Liquichek Urine Chemistry Control |
|---|---|
| Common Name: | Multi-Analyte Controls, All Kinds (Assayed) |
| Classifications: | Class I, reserved |
| Product Code: | JJY |
| Regulation Number: | 21 CFR 862.1660 |
Device to Which Substantlal Equivalence is Claimed 3.0
Liquichek Urine Chemistry Control Bio-Rad Laboratories Irvine, California
510 (k) Number: K020817
Description of Device 4.0
Liquichek Urine Chemistry Control is prepared from human urine with added constituents of human and animal origin, chemicals, preservatives and stabilizers. The control is provided in liquid form for conventence
Value Assignment 5.0
The mean values and the corresponding ±3SD ranges printed in the insert were derived from replicate analyses and are specific for this lot of product. The tests listed were performed by the manufacturer and/or independent laboratories using manufacturer supported reagents and a representative sampling of this lot of product. It is recommended that each laboratory establish its own acceptable ranges and use those provided only as guides. Laboratory established ranges may vary from those listed during the life of this control. Variations over time and between laboratories may be caused by differences in laboratory technique, instrumentation and reagents, or by manufacturer test method modifications.
1 1 2012 JUL
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6.0 Intended Use
Liquichek Urine Chemistry Control is intended for use as an assaved quality control urine to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
7.0 Comparison of the new device with the Predicate Device
Liquichek Urine Chemistry Control claims substantial equivalence to the Liquichek Urine Chemistry Control currently in commercial distribution (K020817). Table 1 (below) contains comparison information of similarities and differences between the new and predicate device to which substantial equivalence is claimed.
| Characteristics | Liquichek Urine Chemistry Control
( New Device ) | Liquichek Urine Chemistry Control
( Predicate Device, K020817 ) |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | Liquichek Urine Chemistry Control is
intended for use as an assayed quality
control urine to monitor the precision of
laboratory testing procedures for the
analytes listed in this package insert. | Liquichek Urine Chemistry Control is
intended for use as an assayed quality
control urine to monitor the precision of
laboratory testing procedures for the
analytes listed in this package insert. |
| Matrix | Human Urine | Human Urine |
| Form | Liquid | Liquid |
| Open Vial Stability | 30 days at 2°C to 8 °C | 30 days at 2°C to 8 °C |
| Storage unopened (Shelf life) | 2 to 8°C until expiration date | 2 to 8°C until expiration date |
| Differences | | |
| Fill Volume | For Level 1 and 2 - 12 x 2.5 mL
For Bilevel MiniPak - 2 x 2.5 mL | For Level 1 and 2 - 12 x 10 mL
For Bilevel MiniPak - 2 x 10 mL |
| Analytes | Contains:
Amylase
Calcium
Chloride
Creatinine
Glucose
Magnesium
Micoalbumin (Albumin)
Phosphorus
Potassium
Protein, Total
Sodium
Urea Nitrogen (BUN)
Uric Acid
Does not contain
Urea
Cortisol
Osmolality
pH
Pregnancy
Specific Gravity | Contains:
Amylase
Calcium
Chloride
Cortisol
Creatinine
Glucose
Magnesium
Micoalbumin (Albumin)
Osmolality
Phosphorus
pH
Pregnancy
Potassium
Protein, Total
Specific Gravity
Sodium
Urea
Urea Nitrogen (BUN)
Uric Acid |
Table 1. Similarities and Differences between new and predicate device.
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Bio-Rad Laboratories Premarket Notification Section 510 (k) Liquichek Urine Chemistry Control
8.0 Statement of Supporting Data
Stability studies have been performed for Liquichek Urine Chemistry control to determine the open vial and shelf life claims. Product claims are as follows:
Open Vial:
Shelf Life Stability
30 days at 2 to 8°C. 24 Months at 2°C to 8°C
Conclusion 9.0
Liquichek Urine Chemistry control is intended to be used for the same purpose as the predicate device. It has the human urine matrix and performs similarly as the predicate device.
All supporting data is retained on file at Blo-Rad Laboratories.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration
10903 New Hampshire Avenue Silver Spring, MD 20993
Bio-Rad Laboratories c/o Suzanne Parsons 9500 Jeronimo Road Irvine, CA 92618-2017
Re: K121794 JUL 11 2012
Trade Name: Liquichek Urine Chemistry Control Regulation Number: 21 CFR §862.1660 Regulation Name: Quality Control Material (assayed) Regulatory Class: Class I, reserved Product Codes: JJY Dated: June 18, 2012 Received: June 19, 2012
Dear Suzanne 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 17 you desire specific ad rive to: Device Evaluation and Safety at (301) 796-5450. Also, commor the regulation entitled, "Misbranding by reference to premarket notification" (21 please note the rogulation regarding postmarket surveillance, please contact CDRB13 Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) Office of But romance and garding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical
Devices/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 Tou may of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm
Sincerely yours,
signature
Countney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety
Center for Devices and Radiological Health
Enclosure
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Indications for Use Form
K121794 510(k) Number (if known):
Device Name:
Liquichek Urine Chemistry control
Indications for Use:
Liquichek Urine Chemistry Control is intended for use as an assayed quality control urine to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
The following analytes are listed in the package insert:
- Amylase
- Calcium
- Chloride
- Creatinine
- Glucose
- Magnesium
- Microalbumin (Albumin)
- Phosphorus
- Potassium
- Protein, total
- Sodium
- Urea Nitrogen (BUN)
- Uric Acid
× 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)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 14121794 510(K)
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