(30 days)
Liquichek Diabetes Control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analyte listed in the package insert.
This product is prepared from human whole blood and contains preservatives and stabilizers. The control is provided in liquid form for convenience.
Here's a breakdown of the acceptance criteria and study information for the Bio-Rad Liquichek Diabetes Control, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Intended Use | To monitor the precision of laboratory testing procedures for the analyte listed in the package insert. | Liquichek Diabetes Control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analyte listed in the package insert. (Matches predicate device) |
| Matrix | Human Whole Blood | Human Whole Blood (Matches predicate device) |
| Form | Liquid | Liquid (Matches predicate device) |
| Thawed Open Vial Stability | 14 days at 2°C to 8°C | 14 days at 2°C to 8°C (Established through real-time stability studies) |
| Thawed Unopened Stability | 180 days at 2°C to 8°C | 180 days at 2°C to 8°C (Established through real-time stability studies) |
| Shelf Life Stability | 3 years at -10°C to -50°C | 3 years at -10°C to -50°C (Established through accelerated stability studies). The predicate device had a shelf life of -10°C to -70°C, indicating a slight difference in the acceptable temperature range while maintaining the same duration. |
| Fill Volume | 2 mL | 2 mL. This is a difference from the predicate device (1 mL), but not framed as an acceptance criterion in this document. |
| Analytes | Hemoglobin A1C | Hemoglobin A1C. The predicate device also included "Hemoglobin," indicating a difference, but not framed as an acceptance criterion for the new device. |
The acceptance criteria are primarily based on demonstrating substantial equivalence to the predicate device (K052838) with respect to stability and intended use, while noting differences in fill volume and the number of analytes.
Study Information
-
Sample Size Used for the Test Set and Data Provenance:
- The document mentions "real-time stability studies" and "accelerated stability studies" were conducted.
- No specific sample sizes (e.g., number of vials, number of replicates, number of lots) for these studies are provided in the summary.
- The data provenance is internal to Bio-Rad Laboratories, with tests performed by "the manufacturer and/or independent laboratories." No specific country of origin for the data is mentioned, but Bio-Rad Laboratories is based in Irvine, California, USA.
- The studies were prospective, as they were conducted to "establish" stability claims.
-
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This information is not provided in the document. The studies conducted were stability studies for a quality control material, which typically involve laboratory testing and comparison to established methods or specifications, rather than expert interpretation of results. The "ground truth" for a control material like this would be its measured analyte concentration and its stability characteristics under various conditions.
-
Adjudication Method for the Test Set:
- This is not applicable/not provided. Adjudication methods (like 2+1, 3+1) are typically used in studies where human interpretation or consensus is required to establish ground truth from subjective data (e.g., imaging studies). For stability testing of a quality control material, the measurements are objective.
-
Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where AI assists human readers. The Liquichek Diabetes Control is a quality control material, not a diagnostic device that humans interpret.
-
Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- No, a standalone study in the context of an algorithm's performance was not done. This device is a physical quality control material for laboratory instruments, not an algorithm. The "performance" here refers to its stability and ability to maintain consistent values.
-
Type of Ground Truth Used:
- The ground truth for the stability studies would be analytical measurements of the Hemoglobin A1C analyte over time under various storage conditions. These measurements are compared against pre-defined specifications or the initially assigned values to determine stability. The "Value Assignment" section states that mean values and ±3SD ranges were derived from testing on the specific lot of product by the manufacturer and independent laboratories.
-
Sample Size for the Training Set:
- This concept is not applicable to this device. As a quality control material, there is no "training set" in the machine learning sense. The "value assignment" process involves testing the manufactured product to establish its initial characteristics.
-
How the Ground Truth for the Training Set Was Established:
- This is not applicable. The "ground truth" for the control material's value is established through analytical testing of the actual product lot. The document states: "The mean values and the corresponding ±3SD ranges printed in this insert were derived... The tests listed were performed by the manufacturer and/or independent laboratories using manufacturer performed by the manufacturer and/or independent laboratories using manufacturer supported reagents and a bio-reductive method... It is recommended that each laboratory establish its own acceptable ranges and use those recommended in this insert only as guides." This indicates a combination of manufacturer testing and a recommendation for end-users to verify.
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JAN 0 9 2013
Page 1 of 2
Bio-Rad Laboratories Premarket Notification Section 510 (k) Liquichek Dlabetes Control
Page 1 of 2
510(k) Summary Liquichek Diabetes Control
Submitter 1.0
Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, Callfornia 92618-2017 (949) 598-1200 Telephone: (949) 598-1557 Fax:
Contact Person
Suzanne Parsons Regulatory Affairs Manager Telephone: (949) 598-1467
Date of Summary Preparation
December 21, 2012
Device Identification 2.0
| Product Trade Name: | Liquichek Diabetes Control |
|---|---|
| Classification Panel: | Clinical Chemistry |
| Common Name: | Single (Specified) Analyte Controls (Assayed and Unassayed) |
| Classification: | Class I, Reserved |
| Product Code: | JJX |
| Regulation Number: | 21 CFR 862.1660 |
Device to Which Substantial Equlvalence is Claimed 3.0
Liquichek Diabetes Control Bio-Rad Laboratories Irvine, California
510 (k) Number: K052838
Description of Device 4.0
This product is prepared from human whole blood and contains preservatives and stabilizers. The control is provided in liquid form for convenience.
Value Assignment 5.0
The mean values and the corresponding ±3SD ranges printed in this insert were derived The mean values and the confessionality as on this lot of product. The tests listed were performed by the manufacturer and/or independent laboratories using manufacturer performed by the manufacturer andror incopenabiling of this lot of product. It is supported Teagents and a Toprocomative camon acceptable ranges and use those recommended that back laboratory established ranges may vary from those listed during provided only as guides. Edboratory over time and between laboratories may be caused by the the of this control. Vanutions over annualion and reagents, or by manufacturer test method modifications.
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6.0 Intended Use
Liquichek Dlabetes Control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analyte listed in the package insert.
Comparison of the new device with the Predicate Device 7.0
Liquichek Diabetes Control claims substantial equivalence to the Liquichek Diabetes Control currently in commercial distribution (K052838). Table 1 (below) contains comparison information of similarities and differences between the new and predicate device to which substantial equivalence is claimed.
| Characteristics | Liquichek Diabetes Control(New Device) | Liquichek Diabetes Control(Predicate Device, K052838) |
|---|---|---|
| Similarities | ||
| Intended Use | Liquichek Diabetes Control is intended foruse as an assayed quality control materialto monitor the precision of laboratorytesting procedures for the analyte listed inthis package Insert. | Liquichek Diabetes Control Is intendedfor use as an assayed quality controlmaterial to monitor the precision oflaboratory testing procedures for theanalyte listed in this package insert. |
| Matrix | Human Whole Blood | Human Whole Blood |
| Form | Liquid | Liquid |
| Thawed OpenedStability | 14 days at 2 to 8°C | 14 days at 2°C to 8 °C |
| Thawed UnopenedStability | 180 days at 2 to 8°C | 180 days at 2 to 8°C |
| Differences | ||
| Fill Volume | 2 mL | 1 mL |
| Storage unopened(Shelf life) | -10°C to -50°C until expiration date | -10°C to -70°C until expiration date |
| Analytes | Hemoglobin A1C | Hemoglobin A1CHemoglobin |
. Statement of Supporting Data 8.0
Real-time stability studies were conducted to establish the thawed stability claims (openvial and unopened). Accelerated stability studies were conducted to establish the shelflife claims at -20 to -50 ℃. Based on the available data, product claims are as follows:
- Thawed Open Vial Stability: 14 days at 2°C to 8 °C .
- Thawed Unopened Stability: 180 days at 2°C to 8 °C .
- Shelf Life Stability: 3 years at -10°C to -50°C .
9.0 Conclusion
Based on the performance characteristics Indicated above, Bio-Rad's Liquichek Diabetes control is substantially equivalent to the predicate device K052838.
All supporting data is retained on file at Bio-Rad Laboratories.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUM AN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
January 9, 2013
Bio-Rad Laboratories c/o Suzanne Parsons 9500 Jeronimo Road Irvine, CA 92618-2017
Re: K123798
Trade/Device Name: Liquichek Diabetes control Regulation Number: 21 CFR §862.1660 Regulation Name: Ouality Control Material Regulatory Class: Class I, Reserved Product Code: JJX Dated: December 7, 2012 Received: December 10, 2012
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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 -- Suzanne Parsons
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/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 Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
for Carol C. Benson
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K123798
Device Name: Liquichek Diabetes control
Indications for Use: Liquichek Diabetes Control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analyte listed in the package insert.
Prescription Use _ X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use __ (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Katherine Serrano 2013.01.09 15:11:51 -05'00'
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k) K123798
§ 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.