(23 days)
Assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert
Liquichek™ Lipids Control is prepared from human serum with added constituents of human and animal origin, pure chemicals preservatives and stabilizers. The control is provided in liquid form for convenience.
The provided document is a 510(k) summary for a medical device (Liquichek™ Lipids Control) and lacks the detailed study information typically found in a clinical trial report or a comprehensive validation study. Therefore, I cannot fully answer all the questions as the specific details requested, such as sample sizes for test and training sets, number of experts, adjudication methods, or MRMC study results, are not present.
However, I can extract the available information regarding acceptance criteria and performance as related to the device's stability.
Here's a breakdown of the available information:
Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the stability claims made for the Liquichek™ Lipids Control. The device is considered to meet these criteria if it maintains its intended function as an assayed quality control serum within the specified storage conditions and timeframes.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Thawed and unopened vial stability: Maintain stability for 14 days at 2-8°C. | "Once the control material is thawed and the vial is unopened all analytes will be stable for 14 days at 2-8°C." (This statement acts as both the claim and the reported performance based on stability studies.) |
| Open vial stability: Maintain stability for 14 days when stored tightly capped at 2-8℃. | "Once the control material is thawed and opened, all analytes will be stable for 14 days when stored tightly capped at 2-8℃." (This statement acts as both the claim and the reported performance based on stability studies.) |
| Shelf Life (unopened): Maintain stability for 36 months when stored at -10 to -20 °C. | "36 months when stored at -10 to -20 °C." (This statement acts as both the claim and the reported performance based on stability studies.) The document also states, "Real time studies will be ongoing to support the shelf life of this product," indicating that preliminary data supported the claim, and further studies were in progress to fully validate it over the entire 36 months. |
Information Not Available in the Provided Document:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): The document mentions "Stability studies have been performed," but does not provide details on sample sizes, specific experimental design, or data provenance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): This is not applicable to a quality control material stability study. The "ground truth" would be the measured analyte concentrations over time, not expert consensus.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable in this context.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a quality control material, not an AI-powered diagnostic device interpreted by human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-based device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this type of device, the "ground truth" for stability would be the analytical measurements of the analytes themselves, traceable to reference methods or materials, to ensure they remain within predefined acceptable ranges over time. However, the specific methods are not detailed here.
- The sample size for the training set: Not applicable. This is not a machine learning or AI device that requires a training set.
- How the ground truth for the training set was established: Not applicable.
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Page 1 of 2
AUG 2 9 2001
Summary of Safety and Effectiveness
Liquichek™ Lipids Control
Submitter 1.0
Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 (949) 598-1200 Telephone: (949) 598-1555 Fax:
Contact Person
Maria Zeballos Requlatory Affairs Specialist Telephone: (949) 598-1367
Date of Summary Preparation
August 3, 2001
Device Identification 2.0
| Product Trade Name: | Liquichek™ Lipids Control |
|---|---|
| Common Name: | Multi-Analyte Controls, (Assayed and unassayed) |
| Classifications: | Class I |
| Product Code: | 75JJT |
CFR 862.1660 Regulation Number:
3.0 Device to Which Substantial Equivalence is Claimed
Liquichek™ Lipids Control Bio-Rad Laboratories Irvine, California
Docket Number: K002460
4.0 Description of Device
Liquichek™ Lipids Control is prepared from human serum with added constituents of human and animal origin, pure chemicals preservatives and stabilizers. The control is provided in liquid form for convenience.
5.0 Statement of Intended Use
Liquichek™ Lipids Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures listed in the package insert.
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Comparison of the new device with the Predicate Device 6.0
The new Liquichek™ Lipids Control claims substantial equivalence to the Liquichek™ Lipids Control currently in commercial distribution (K002460). The new Liquichek™ Lipids Control contains C-reactive Protein (CRP) and the current product does not.
| Table 1. Similarities and Differences between new and predicate device | ||
|---|---|---|
| Characteristics | Bio RadLiquichek™ Lipids Control(New Device) | Bio RadLiquichek™ Lipids Control(Predicate Device) |
| Similarities | ||
| Intended Use | Liquichek™ Lipids Control is intended foruse as an assayed quality control serumto monitor the precision of laboratorytesting procedures for the analytes listedin the package insert. | Liquichek™ Lipids Control is intended foruse as an assayed quality control serumto monitor the precision of laboratorytesting procedures for the analytes listedin the package insert. |
| Form | Liquid | Liquid |
| Matrix | Human serum based | Human serum based |
| Storage(Unopened) | -10 °C to -20°Cuntil expiration date | -10 °C to -20°Cuntil expiration date |
| Storage(Thawed and unopened) | 14 days at 2-8°C | 14 days at 2-8°C |
| Open Vial Claim | 14 days at 2-8°C | 14 days at 2-8°C |
| Differences | ||
| Analytes | Similar analytes as the predicate devicewith the additional claims for CRP | Does not contain CRP. |
Table 1. Similarities and Differences between new and predicate device
Summary of Performance Data 7.0
Stability studies have been performed to determine the open vial stability and shelf life for the Liquichek™ Lipids Control. Product claims are as follows:
- Thawed and unopened vial: Once the control material is thawed and the vial is 7.1 unopened all analytes will be stable for 14 days at 2-8°C.
- Open vial: Once the control material is thawed and opened, all analytes will be 7.2 stable for 14 days when stored tightly capped at 2-8℃.
- Shelf Life: 36 months when stored at -10 to -20 °C 7.3
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/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
AUG 2 9 2001
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Elizabeth Platt Regulatory Affairs Manager Bio-Rad Laboratories, QSD 9500 Jeronimo Road Irvine, CA 92618
Re: K012513 Trade/Device Name: Liquichek Lipids Control Regulation Number: 21 CFR 862.1660 Regulatory Class: I, reserved Product Code: JJY Dated: August 3, 2001 Received: August 6, 2001
Dear Ms. Platt:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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.
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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 nouticate 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 1 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, (201) 59 + 15 cl (1 c 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 Butman
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): Hol2513
Device Name: Liquichek™ Lipids Control
Indications for Use:
Assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert
(PLEASE DO NOT WRITE BELOW THE LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) 1 Prescription use Over-the Counter use__________________________________________________________________________________________________________________________________________________________ _ or 510(k) 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.