(69 days)
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.
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.
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.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the "Liquichek Microalbumin Control":
This document is a 510(k) Premarket Notification for a medical device, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study against predefined acceptance criteria in the same way a novel device might. The "acceptance criteria" here are implicitly tied to the performance of the predicate device and the stability of the new control material itself.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of this submission (a control material seeking substantial equivalence), the "acceptance criteria" are primarily related to the stability claims, which are demonstrated to be within acceptable limits for a quality control material.
| Acceptance Criteria (Implied from Submission) | Reported Device Performance |
|---|---|
| Open Vial Stability: Able to monitor precision for at least 30 days when stored tightly capped at 2-8 °C. | Open Vial Stability: All analytes stable for 30 days when stored tightly capped at 2-8 °C. |
| Shelf Life (Unopened): Stable for an extended period when stored at 2-8 °C. | Shelf Life: Two years when stored at 2-8 °C (with ongoing real-time studies). |
| Matrix: Human urine based. | Matrix: Human urine based. |
| Form: Liquid. | Form: Liquid. |
| Intended Use: As an assayed quality control urine to monitor precision of laboratory procedures for listed analytes. | Intended Use: As an assayed quality control urine to monitor the precision of laboratory procedures for microalbumin and creatinine. |
Note: The document emphasizes that the new device (Liquichek Microalbumin Control) is substantially equivalent to the predicate device (Liquichek Urine Chemistry Control) in many key characteristics (intended use, form, matrix, storage claims) and simply has a more focused analyte panel. The core "performance data" presented directly relates to the stability of the control material, ensuring it reliably functions as intended during its shelf life and open-vial period.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the traditional sense of a clinical study with patient samples. The performance data presented refers to stability studies conducted on the control material itself.
- Sample Size: Not explicitly stated as a number of samples in the context of a clinical study, but rather implied through the successful completion of stability experiments on the control material.
- Data Provenance: The stability studies were conducted by Bio-Rad Laboratories. The country of origin for the data is implicitly the United States, where Bio-Rad Laboratories is located. The studies are prospective as they track the performance of the control material over time for open-vial and shelf-life stability.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable to this type of submission. This device is a quality control material, not a diagnostic device that interprets clinical data or images requiring expert judgment for ground truth. The "ground truth" for a control material is its chemical composition and stability characteristics, measured through analytical methods.
4. Adjudication Method for the Test Set
Not applicable. There is no "adjudication" for stability testing of a quality control material. The assessment is based on objective chemical analysis and predefined statistical criteria for stability.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is relevant for diagnostic imaging systems or clinical decision support tools where multiple human readers interpret cases. This document is for a laboratory quality control material.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This device is a laboratory reagent (quality control material), not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established through:
- Chemical Analysis and Reference Measurements: The actual concentrations of microalbumin and creatinine within the control material are determined using validated analytical methods.
- Stability Studies: These studies involve periodically measuring the analyte concentrations in the control material under specified storage conditions (e.g., 2-8 °C) over time to ensure they remain within predefined acceptable limits of variation. This demonstrates the material's consistency and reliability as a control.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This device does not have a training set.
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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.
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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 isintended for use as assayed qualitycontrol urine to monitor the precision oflaboratory testing procedures for analyteslisted in the package insert. | Liquichek Urine Chemistry Control isintended for use as assayed quality controlurine to monitor the precision of laboratorytesting procedures for analytes listed in thepackage insert. |
| Form | Liquid | Liquid |
| Matrix | Human urine based | Human urine based |
| Shelf StorageClaim (Unopened) | 2 to 8°CUntil expiration date | 2 to 8°CUntil 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.
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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).
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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
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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
§ 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.