(69 days)
Not Found
No
The document describes a quality control material for laboratory procedures and does not mention any AI or ML components.
No
The device is described as an assayed quality control urine intended to monitor the precision of laboratory procedures, not to treat or diagnose patients.
No
This device is a quality control material intended to monitor the precision of laboratory procedures, not to diagnose a condition in a patient.
No
The device description clearly states it is prepared from human urine with added constituents, indicating it is a physical control material, 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 laboratory procedures" for analytes in urine. This is a classic function of an IVD control material used in a laboratory setting.
- Device Description: It's a prepared material (human urine with added constituents) intended for use in laboratory testing.
- Intended User / Care Setting: It's intended for use in a "laboratory".
- Predicate Device: The mention of a predicate device (K020817; Liquichek Urine Chemistry Control) strongly suggests that this device is also an IVD, as predicate devices are used in the regulatory process for new IVDs.
While it doesn't perform a diagnostic test itself, it is a critical component used in vitro (outside the body) within a laboratory setting to ensure the accuracy and reliability of diagnostic tests. This fits the definition of an IVD control material.
N/A
Intended Use / Indications for Use
Liquichek Microalbumin Control is intended for use as an assayed quality control material 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 Microalbumin Control is prepared from human urine with added constituents of human, pure chemicals, preservatives and stabilizers. The contral is provided in Iliginal form for convenience.
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 Liquichek Microalbumin 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: Two years when stored at 2-8 °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 (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
Summary of Safety and Effectiveness Liquichek Microalbumin Control
1.0 Submitter
Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 Telephone: (949) 598-1200 (949) 598-1555 Fax:
DEC 1 1 2007
Contact Person
Suzanne Parsons Regulatory Affairs Specialist Telephone: (949) 598-1467
Date of Summary Preparation
September 27, 2007
2.0 Device Identification
| Product Trade Name: | Liquichek Microalbumin 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: K020817
4.0 Description of Device
Liquichek Microalbumin Control is prepared from human urine with added constituents of human, pure chemicals, preservatives and stabilizers. The contral is provided in Iliginal form for convenience.
5.0 Statement of Intended Use
Liquichek Microalbumin 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 Microalbumin Control claims substantial equivalence to the Liquichek Urine Chemistry Control currently in commercial distribution (K020817). The new Liquichek Microalbumin Control contains claims only for microalbumin and creatinine.
| Bio-Rad Laboratories | Bio-Rad Laboratories | |
|---|---|---|
| Characteristics | Liquichek Microalbumin Control | |
| (New Device) | Liquichek Urine Chemistry Control | |
| (Predicate Device) | ||
| Similarities | ||
| Intended Use | Liquichek Microalbumin 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 |
| Shelf Storage | ||
| Claim (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: Microalbumin and creatinine | Contains: |
| Does not contain: |
- Amylase
- Calcium
- Chloride
- Cortisol
- Glucose
- Magnesium
- Osmolality
- pH
- Phosphorus | - Potassium
- Pregnancy
- Protein, Total
- Sodium
- Specific Gravity
- Urea
- Urea Nitrogen
- Uric Acid |
| | | - Amylase - Calcium
- Chloride
- Cortisol
- Creatinine
- Glucose
- Magnesium
- Microalbumin
- Osmolality
- pH |
| | | - Phosphorus - Potassium
- Pregnancy
- Protein, Total
- Sodium
- Specific Gravity
- Urea
- Urea Nitrogen
- Uric Acid |
| 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 Microalbumin Control. Product claims are as follows:
- 7.1 Open vial: Once the control material is opened, all analytes will be stable for 30 days when stored tightly capped at 2-8 °C.
- 7.2 Shelf Life: Two years when stored at 2-8 °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.
2
Image /page/2/Picture/1 description: The image shows a circular seal with an emblem in the center. The emblem appears to be a stylized bird with three curved lines representing its body and wings. The text around the circle is difficult to read due to the image quality, but it seems to be part of an official agency or organization's name. The seal is black and white and has a simple, clean design.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 1 1 2007
Bio-Rad Laboratories Diagnostics Group c/o Ms. Suzanne Parsons Regulatory Affairs Specialist 9500 Jeronimo Road Irvine, CA 92618-2017
Re: K072835 Trade Name: Liquichek™ Microalbumin Control Levels 1 & 2 Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed). Regulatory Class: Class I Product Code: JJY Dated: October 01, 2007 Received: November 16, 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).
3
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 (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. Cooper, M.S., D.V.M.
Yéan 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
4
Indications for Use
510(k) Number (if known):
Device Name:
Indications For Use:
Liquichek Microalbumin Control
Liquichek Microalbumin Control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
Prescription Use X (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
L. Sign-Off
Page 1 of
Office of In Vitro Diagnostic Device Juation and Safety :
14072835