(8 days)
An assayed quality control serum to monitor the precision of laboratory testing procedures for analytes listed in the package insert.
Liquichek™ Immunology Control is prepared from human serum with added serum proteins, constituents of animal origin, preservatives and stabilizers. The control is provided in liquid form for convenience.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stability Claims) | Reported Device Performance |
|---|---|
| Open Vial Stability: All analytes stable for 30 days when stored tightly capped at 2 to 8°C. | Once the product is thawed and opened, all analytes will be stable for 30 days when stored tightly capped at 2 to 8°C. |
| Open Vial Exception: Rheumatoid Factor stable for 21 days when stored tightly capped at 2 to 8°C. | Rheumatoid Factor will be stable for 21 days when stored tightly capped at 2 to 8°C. |
| Closed Vial Stability: All analytes stable for 90 days once thawed and stored unopened at 2 to 8°C. | Once thawed and stored unopened at 2 to 8°C, all analytes will be stable for 90 days. |
| Shelf Life: Two years when stored at -10 to -20 °C. | Two years when stored at -10 to -20 °C. (Stated as a claim, with ongoing real-time studies.) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the stability studies (test set). It mentions "Stability studies have been performed," but does not provide details on the number of batches, vials, or measurements taken. The data provenance is also not specified. It is likely that the testing was conducted at Bio-Rad Laboratories (the submitter and manufacturer) in Irvine, California. The studies are described as "real-time studies will be ongoing to support the shelf life," suggesting a prospective nature for the shelf-life portion, while the open and closed vial stability studies likely involved specific testing periods to establish those claims.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable to this device and study type. The "ground truth" for a quality control material like Liquichek™ Immunology Control is its stability over time under specified conditions, determined by analytical testing methods to measure analyte concentrations. It does not involve expert interpretation or clinical diagnosis.
4. Adjudication Method for the Test Set
This information is not applicable to this device and study type. Clinical adjudication methods (like 2+1, 3+1) are used for studies involving subjective interpretations (e.g., medical imaging), which is not the case for a quality control material demonstrating analytical stability.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is designed to assess the impact of a device (often AI-based) on human reader performance in diagnostic tasks, which is not relevant for an immunology quality control product. The purpose of this submission is to demonstrate the stability and substantial equivalence of the quality control material itself.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone (algorithm only) performance study was not done, as this product is not an algorithm or AI-driven diagnostic device. The performance refers to the stability of the control material's analytes.
7. The Type of Ground Truth Used
The "ground truth" for the stability studies is established through analytical testing methods to quantify the concentration of each analyte in the control material over time under various storage conditions. The acceptable range for these concentrations (what constitutes "stable") would be defined internally by Bio-Rad Laboratories based on established analytical performance specifications. It is a measurement-based ground truth, not expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
This information is not applicable. This device is an immunology control product, not an algorithm that requires a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no "training set" for this device.
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Summary of Safety and Effectiveness Liguichek™ Immunology Control
1.0 Submitter
SEP 1 7 2002
Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 Telephone: (949) 598-1200 (949) 598-1555 Fax:
Contact Person
Maria Zeballos Regulatory Affairs Specialist Telephone:
Date of Summary Preparation
September 2, 2002
2.0 Device Identification
| Product Trade Name: | Liquichek™ Immunology Control |
|---|---|
| Common Name: | Multi-Analyte Controls, (Assayed and unassayed) |
| Classifications: | Class I |
| Product Code: | 75JJY |
| Regulation Number: | CFR 862.1660 |
3.0 Device to Which Substantial Equivalence is Claimed
Liquichek™ Immunology Control Bio-Rad Laboratories Irvine, California
Docket Number: K011494
4.0 Description of Device
Liquichek™ Immunology Control is prepared from human serum with added serum proteins, constituents of animal origin, preservatives and stabilizers. The control is provided in liquid form for convenience.
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5.0 Statement of Intended Use
Liquichek™ Immunology Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for analytes listed in this package insert.
Comparison of the new device with the Predicate Device 6.0
The new Liquichek™ Immunology Control claims substantial equivalence to the Liquichek™ Immunology Control currently in commercial distribution (K011494). The new Liquichek™ Immunology Control contains ADNase B, C1-Inhibitor, Cystatin-C, IgG subclasses, Lp (a) and the current product does not.
| Bio Rad | Bio Rad | |
|---|---|---|
| Characteristics | LiquichekTM Immunology Control(New Device) | LiquichekTM Immunology Control(Predicate Device) |
| Similarities | ||
| Intended Use | LiquichekTM Immunology Control isintended for use as an assayed qualitycontrol serum to monitor the precision oflaboratory testing procedures foranalytes listed in this package insert. | LiquichekTM Immunology Control isintended for use as an assayed qualitycontrol serum to monitor the precision oflaboratory testing procedures for analyteslisted in this package insert. |
| Form | Liquid | Liquid |
| Matrix | Human serum based | Human serum based |
| Storage(Unopened Frozen) | -10 °C to -20°Cuntil expiration date | -10 °C to -20°Cuntil expiration date |
| Storage(Unopened Thawed) | 90 days at 2-8° C | 90 days at 2-8° C |
| Open Vial Claim | 30 days at 2-8° C with the followingexception: Rheumatoid Factor is stablefor 21 days at 2 to 8°C | 30 days at 2-8° C with the followingexception: Rheumatoid Factor is stable for21 days at 2 to 8°C |
| Differences | ||
| Same analytes as the predicate devicewith the additional claims for ADNase B,C1-Inhibitor, Cystatin-C, IgG subclasses,and Lp (a). | ADNase B, C1-Inhibitor, Cystatin-C, IgGsubclasses, and Lp (a) are not included. |
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 Immunology Control. Product claims are as follows:
- 7.1 Open vial: Once the product is thawed and opened, all analytes will be stable for 30 days when stored tightly capped at 2 to 8°C with the exception of Rheumatoid Factor, which will be stable for 21 days.
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- 7.2 Closed Vial: Once thawed and stored unopened at 2 to 8°C, all analytes will be stable for 90 days.
- 7.3 Shelf Life: Two years when stored at -- 10 to -- 20 °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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Maria Zeballos Regulatory Affairs Specialist Bio-Rad Laboratories 9500 Jeronimo Road Irvine, California 92618-2017
SEP 1 7 2002
Rc: K022991
Trade/Device Name: Liquichek™M Immunology Control Regulation Number: 21 CFR § 862.1660 Regulation Name: Quality Control Material (Assayed and Unassayed) Regulatory Class: I Product Code: JJY Dated: September 6, 2002 Received: September 9, 2002
Dear Ms. Zeballos:
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 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); 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.
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Page 2
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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. 510 (k) Number (if known): K022991
Device Name: Liquichek™ Immunology Control
Indications for Use:
An assayed quality control serum to monitor the precision of laboratory testing procedures for analytes listed in the package insert.
(PLEASE DO NOT WRITE BELOW THE LINE-CONINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription use or Over-the Counter use
Deborah M. Moore
§ 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.