(29 days)
Liquichek Immunology Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in this package insert.
Liquichek Immunology Control is prepared from defibrinated human plasma with added serum proteins, stabilizers and preservatives. This provided in liquid form for convenience. Each human donor unit used to manufacture this control was tested by FDA accepted methods and found non-reactive for Hepatitis B Surface Antigen (HBsAg), antibody to Hepatitis C (HCV) and antibody to HIV-1/HIV-2.
Here's an analysis of the provided information regarding the Liquichek Immunology Control device, broken down by your requested sections:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Predicate Device) | Reported Device Performance (New Device) |
|---|---|---|
| Intended Use | Assayed quality control serum to monitor the precision of laboratory testing procedures for listed analytes. | Assayed quality control serum to monitor the precision of laboratory testing procedures for listed analytes. |
| Base Matrix | Defibrinated Human Plasma | Defibrinated Human Plasma |
| Form | Liquid | Liquid |
| Thawed and Opened Stability | Beta-2-Microglobulin: 21 days at 2 to 8°C.Rheumatoid Factor: 5 days at 2 to 8°C.All other analytes: 30 days at 2 to 8°C. | Beta-2-Microglobulin: 21 days at 2 to 8°C.Rheumatoid Factor: 10 days at 2 to 8°C.All other analytes: 30 days at 2 to 8°C. |
| Thawed and Unopened Stability | All analytes: 90 days at 2 to 8°C.Except Rheumatoid Factor: 25 days at 2 to 8°C. | Beta-2-Microglobulin: 40 days at 2 to 8°C.Rheumatoid Factor: 10 days at 2 to 8°C.All other analytes: 45 days at 2 to 8°C. |
| Shelf Life | -20 to -70°C until expiration | 24 months at -20 to -70°C |
| Analytes | List of 34 analytes (including ADNase B, Albumin, Alpha 1-Antitrypsin, etc.) and explicitly "Does not contain: Anti-CCP". | List of 36 analytes (including ADNase B, Albumin, Anti-CCP, Hemopexin, etc.). Notable additions include Anti-CCP and Hemopexin, and removal of some explicit mentions. |
Note on Acceptance Criteria: For this device, "acceptance criteria" are implied by the claim of substantial equivalence to the predicate device. The new device must demonstrate performance that is "as good as" or "equivalent" to the predicate, especially regarding stability claims and the ability to control the listed analytes. The provided document highlights the similarities and differences, and the performance characteristics for the new device are presented as meeting the requirements for its intended use, which are aligned with the predicate's purpose.
2. Sample Size Used for the Test Set and Data Provenance
The document states that "Real time stability studies were performed to establish Thawed and Thawed and unopened stability claims. Accelerated stability studies were performed for establishing the shelf life." It also mentions that "the mean values and corresponding ±3SD ranges in the Assignment of Values Data Charts (available separately) were derived from replicate analyses... 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."
- Sample Size: The exact sample size (number of control units, number of replicates) for these studies is not explicitly stated in the provided document. It refers generally to "replicate analyses" and "a representative sampling."
- Data Provenance:
- Country of Origin: Not explicitly stated, though Bio-Rad Laboratories is based in Irvine, California, USA, making it highly probable the data is primarily from the USA or laboratories affiliated with Bio-Rad globally.
- Retrospective or Prospective: The stability studies are described as "real-time" and "accelerated," which indicates prospective data collection. The value assignment process using "replicate analyses" would also be prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
For this type of device (quality control material), the concept of "ground truth" established by experts in the context of diagnostic interpretation (e.g., radiologists) is not applicable.
Instead, the "ground truth" for the test set (i.e., the established concentration ranges and stability) is determined through:
- Replicate Analyses: Multiple measurements of various analytes using established, validated methods.
- Manufacturer and Independent Laboratories: Measurements are performed by Bio-Rad Laboratories and/or independent laboratories.
- Unity™ Interlaboratory Program: Data from this program is included in the determination of some ranges, which indicates a wider consensus approach for value assignment based on multiple laboratory results.
There are no "experts" in the sense of clinicians or diagnosticians establishing ground truth for individual cases, as this is a quality control material intended to monitor the precision of laboratory procedures, not diagnose patients. The "experts" are more akin to highly skilled laboratory technicians and statisticians who conduct and analyze the reference measurements. No specific number or qualifications are given beyond "manufacturer and/or independent laboratories."
4. Adjudication Method for the Test Set
Not applicable. As explained above, this isn't a diagnostic device where expert adjudication of cases is performed. The "adjudication" of the control's values and stability is based on meticulous laboratory testing, statistical analysis of replicate measurements, and interlaboratory comparisons (Unity™ program).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is relevant for diagnostic devices where multiple human readers interpret medical images or data. The Liquichek Immunology Control is a quality control material, not a diagnostic tool requiring human interpretation for its function.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This device is a consumable laboratory reagent, not an algorithm or software. Therefore, the concept of "standalone performance" in the context of AI algorithms is not applicable. Its performance is inherent in its chemical and biological stability and the accuracy of its assigned values when measured by laboratory instruments.
7. The Type of Ground Truth Used
The "ground truth" for the Liquichek Immunology Control is primarily:
- Reference Values: Analytes are assigned mean values and corresponding ±3SD ranges based on replicate analyses using manufacturer-supported reagents and methods.
- Stability Data: Determined scientifically through real-time and accelerated stability studies.
This is a form of empirical measurement data derived from robust laboratory procedures, rather than expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
Not applicable. This device is a physical quality control material, not a machine learning algorithm. Therefore, there is no "training set." Its values are established through laboratory testing and statistical analysis, not by training an AI model.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an AI algorithm, there is no ground truth established for it. The analogous process for this device is the "Value Assignment" described in section 5.0, where mean values and ±3SD ranges are derived from replicate analyses performed by the manufacturer and/or independent laboratories, often incorporating data from interlaboratory programs.
{0}------------------------------------------------
Page 1 of 3
510(k) Summary
Liquichek Immunology Control
APR 2 5 2014
1.0 Submitter
Bio-Rad Laboratories 9500 Jeronimo Road. Irvine, California 92618-2017 Telephone: (949) 598-1200 (949) 598-1557 Fax:
Contact Person
Suzanne Parsons RA/QA Supervisor Telephone: (949) 598-1467
Date of Summary Preparation
March 25th, 2014
2.0 Device Identification
Product Trade Name: Common Name: Classifications: Product Code: Regulation Number:
Liquichek Immunology Control Multi-Analyte Controls, All Kinds (Assayed) Class I, Reserved JJY 21 CFR 862.1660
3.0 Device to Which Substantial Equivalence is Claimed
Liquichek Immunology Control Bio-Rad Laboratories Predicate 510(k) Number: K022991
4.0 Description of Device
Liquichek Immunology Control is prepared from defibrinated human plasma with added serum proteins, stabilizers and preservatives. This provided in liquid form for convenience.
Each human donor unit used to manufacture this control was tested by FDA accepted methods and found non-reactive for Hepatitis B Surface Antigen (HBsAg), antibody to Hepatitis C (HCV) and antibody to HIV-1/HIV-2.
5.0 Value Assignment
The mean values and corresponding ±3SD ranges in the Assignment of Values Data Charts (available separately) were derived from replicate analyses and are specific for this lot of product. Data from Unity™ Interlaboratory Program are included in the determination of some ranges. 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
{1}------------------------------------------------
over time and between laboratories may be caused by differences in laboratory technique, instrumentation and reagents, or by manufacturer test method modifications.
6.0 Intended Use
Liquichek Immunology Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in this package insert.
7.0 Comparison of the new device with the Predicate Device
Liquichek Immunology Control claims substantial equivalence to Liquichek Immunology Control (K022991). Table 1 (below) contains comparison information of similarities and differences between the new and predicate device to which substantial equivalence is claimed.
| Table 2: Comparison between the predicate and new Liquichek Immunology Control | |||||||
|---|---|---|---|---|---|---|---|
| Characteristics | Predicate Device | New Device | |||||
| Liquichek Immunology Control (K022991) | Liquichek Immunology Control | ||||||
| Similarities | |||||||
| Product Name | Liquichek Immunology Control | Liquichek Immunology Control | |||||
| Intended Use | Liquichek Immunology Control is intended for use as anassayed quality control serum to monitor the precisionof laboratory testing procedures for the analytes listedin this package insert. | Liquichek Immunology Control is intended for use as anassayed quality control serum to monitor the precision oflaboratory testing procedures for the analytes listed in thispackage insert. | |||||
| Base Matrix | Defibrinated Human Plasma | Defibrinated Human Plasma | |||||
| Form | Liquid | Liquid | |||||
| Thawed andOpened Stability | 30 days at 2 to 8°C | 30 days at 2 to 8°C | |||||
| Except | Beta-2-Microglobulin: 21 days at 2 to 8°CRheumatoid Factor: 5 days at 2 to 8°C | Except | Beta-2-Microglobulin: 21 days at 2 to 8°CRheumatoid Factor: 10 days at 2 to 8°C | ||||
| Shelf life | -20 to -70°C until expiration | -20 to -70°C until expiration | |||||
| Differences | |||||||
| Thawed andUnopened Stability | All analytes: 90 days at 2 to 8°C | All analytes: 45 days at 2 to 8°C | |||||
| Except | Rheumatoid Factor: 25 days at 2 to 8°C | Except | Beta-2-Microglobulin: 40 days at 2 to 8°CRheumatoid Factor: 10 days at 2 to 8°C | ||||
| Analytes | Contains | Contains | |||||
| ADNase B | IgG Subclass 1 | ADNase B | Hemopexin | ||||
| Albumin | IgG Subclass 2 | Albumin | IgG Subclass 1 | ||||
| Alpha 1-Antitrypsin | IgG Subclass 3 | Alpha 1-Antitrypsin | IgG Subclass 2 | ||||
| Alpha 2-Macroglobulin | IgG Subclass 4 | Alpha 2-Macroglobulin | IgG Subclass 3 | ||||
| Alpha-1-Acid Glycoprotein | Immunoglobulin AImmunoglobulin E | Alpha-1-Acid GlycoproteinAnti-CCP | IgG Subclass 4Immunoglobulin A | ||||
| Antistreptolysin-OAntithrombin III (AT III)Apolipoprotein A-IApolipoprotein BBeta-2-MicroglobulinC1 Inhibitor | Immunoglobulin G | Antistreptolysin-OAntithrombin III (AT III) | Immunoglobulin E | ||||
| Immunoglobulin M | Immunoglobulin G | ||||||
| Kappa Light Chain | Apolipoprotein A-I | Immunoglobulin M | |||||
| Lambda Light Chain | Apolipoprotein BBeta-2-Microglobulin | Kappa Light Chain | |||||
| Lipoprotein (a) | Lambda Light Chain | ||||||
| Ceruloplasmin | Prealbumin | C1 Inhibitor | Lipoprotein (a) | ||||
| Complement C3 | Properdin Factor B | Ceruloplasmin | Prealbumin | ||||
| Complement C4 | Protein Serum (Total) | Complement C3 | Properdin Factor B | ||||
| C-Reactive Protein (CRP) | Retinol Binding Protein | Complement C4 | Protein Serum (Total) | ||||
| C-Reactive Protein (hsCRP) | Rheumatoid Factor | C-Reactive Protein (CRP) | Retinol Binding Protein | ||||
| Cystatin C | Soluble Transferrin Receptor | C-Reactive Protein (hsCRP) | Rheumatoid Factor | ||||
| Ferritin | Total Hemolytic Complement | Cystatin C | Soluble Transferrin Receptor | ||||
| Haptoglobin | Transferrin | Ferritin | Total Hemolytic Complement | ||||
| Hemopexin | Haptoglobin | Transferrin | |||||
| Does not contain: | |||||||
| Anti-CCP |
Table 1. Similarities and Differences between new and predicate device.
{2}------------------------------------------------
8.0 Statement of Supporting Data
Real time stability studies were performed to establish Thawed and Thawed and unopened stability claims. Accelerated stability studies were performed for establishing the shelf life stabilities for Liquichek Immunology Control are as follows
| Thawed and Opened Stability | Beta-2-Microglobulin: 21 days at 2 to 8°CRheumatoid Factor: 10 days at 2 to 8°CAll other analytes: 30 days at 2 to 8°C |
|---|---|
| Thawed and Unopened Stability | Beta-2-Microglobulin: 40 days at 2 to 8°CRheumatoid Factor: 10 days at 2 to 8°CAll other analytes: 45 days at 2 to 8°C |
| Shelf Life stability: | 24 months at -20 to -70°C |
9.0 Conclusion
Based on the performance characteristics indicated above, Liquichek Immunology Control is substantially equivalent to the predicate device (K022991).
All supporting data is retained on file at Bio-Rad Laboratories.
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 25, 2014
BIO-RAD LABORATORIES SUZANNE S. PARSONS REGULATORY AFFAIRS MANAGER 9500 JERONIMO ROAD IRVINE CA 92618
Re: K140764
Trade/Device Name: Liquicheck Immunology Control Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: I, Reserved Product Code: JJY Dated: March 25, 2014 Received: March 27, 2014
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 Parts 801 and 809); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.
{4}------------------------------------------------
Page 2-Ms. Parsons
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Elizabeth A. Stafford -S
for Maria M. Chan, Ph.D.
Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K140764
Device Name
Liquichek Immunology Control
Indications for Use (Describe)
Liquichek Immunology Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in this package insert.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Elizabeth A. Stafford -S
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
§ 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.