(56 days)
Liquichek Cardiac Markers Plus Control, Cardiac Markers Plus Control LT and Cardiac Markers Plus Control LT Low are intended for use as a quality control serum to monitor the precision of laboratory testing procedures listed in the package insert.
These products are prepared from human serum with added constituents of human and animal origin, preservatives and stabilizers. These controls are provided in liquid form.
The provided text is a 510(k) summary for the Liquichek™ Cardiac Markers Plus Controls. It describes a new quality control device and claims substantial equivalence to a predicate device. The document does not describe a study involving an AI/digital health device, nor does it provide acceptance criteria and performance data in the context of such a device.
Instead, the document focuses on:
- Device Identification: Product names, classification, and regulation details.
- Predicate Device: K040277, Liquichek™ Cardiac Markers Control LT.
- Device Description: Made from human serum with added constituents.
- Intended Use: Quality control serum to monitor precision of laboratory testing.
- Comparison to Predicate: Highlights new analytes (BNP, Creatine Kinase, Total, CRP) and extended open vial stability (20 days vs. 10/5 days).
- Supporting Data: Mentions stability studies for open vial (20 days at 2-8°C) and shelf life (3 years at -20°C to -70°C). These are described as "product claims" based on "stability studies" that "will be ongoing to support the shelf life."
Therefore, I cannot fulfill your request for the specific items (1-9) as they pertain to an AI/digital health device study because the provided text is for a laboratory quality control material and not a software algorithm or a device that would typically undergo such studies.
The document is a submission to the FDA seeking clearance for a new in-vitro diagnostic (IVD) quality control product, asserting its substantial equivalence to a previously cleared product. The "acceptance criteria" and "study" mentioned refer to the stability testing performed to establish shelf life and open-vial stability of the control material itself, ensuring it performs consistently over time for its intended purpose of monitoring laboratory test precision.
Here's how I can address the request based on the actual content of the document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative "acceptance criteria" for the device's performance in the typical sense of sensitivity, specificity, accuracy for an AI/digital health device. Instead, it makes product claims supported by stability studies.
| Acceptance Criteria Category (Implied) | Reported Device Performance (Product Claims) |
|---|---|
| Open Vial Stability | All analytes stable for 20 days at 2-8°C. |
| Shelf Life Stability | 3 years at -20°C to -70°C. |
| Functionality (Intended Use) | Functions as a quality control serum to monitor the precision of laboratory testing procedures. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states: "Stability studies have been performed to determine the open vial stability and shelf life for the Liquichek™ Cardiac Markers Plus Control." It also mentions "Real time studies will be ongoing to support the shelf life of this product."
- Sample Size: Not specified. (For stability studies, this usually refers to the number of control vials tested over different time points and conditions, not patient samples).
- Data Provenance: Not explicitly stated, but assumed to be internal data from Bio-Rad Laboratories (Irvine, California, USA), given they are the submitter. The studies are described as prospective in nature, especially with "real time studies... ongoing."
3. 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. The product is a laboratory quality control material. Ground truth in this context would be the certified values of the analytes within the control material, established through rigorous manufacturing and assay procedures, not by expert consensus or interpretation of medical images/data. The "experts" would be the scientists and chemists involved in the formulation and analytical validation of the control.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations of clinical data (e.g., radiology reads). This is irrelevant for a chemical quality control product.
5. 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 is for an AI/digital health device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is for an AI/digital health device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For a quality control material, the "ground truth" (or target values) for the analytes within it are established during manufacturing and assay validation using reference methods and calibrated instruments. This is an analytical/chemical ground truth, not based on expert clinical consensus or patient outcomes.
8. The sample size for the training set
Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This device is not an AI/ML algorithm.
{0}------------------------------------------------
! バ Page 1 of 2
Summary of Safety and Effectiveness Liquichek™ Cardiac Markers Plus Controls
1.0 Submitter
Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 Telephone: (949) 598-1200 Fax: (949) 598-1557
Contact Person
Suzanne S. Parsons Regulatory Affairs Specialist Telephone: (949) 598-1467
Date of Summary Preparation
February 16, 2005
2.0 Device Identification
| Product Trade Name: | Liquichek Cardiac Markers Plus Control |
|---|---|
| Liquichek Cardiac Markers Plus Control LT | |
| Liquichek Cardiac Markers Plus Control LT Low |
Common Name: Multi-Analyte Controls, all kinds (Assayed and Unassayed)
| Classifications: | Class I |
|---|---|
| Product Code: | JJY |
| Regulation Number: | CFR 862.1660 |
3.0 Device to Which Substantial Equivalence is Claimed
Liquichek™ Cardiac Markers Control LT Bio-Rad Laboratories Irvine, California
Docket Number: K040277
4.0 Description of Device
These products are prepared from human serum with added constituents of human and animal origin, preservatives and stabilizers. These controls are provided in liquid form.
5.0 Statement of Intended Use
- 6.0 Liquichek: Cardiac Markers Plus Control, Cardiac Markers Plus Control LT and Cardiac Markers Plus Control LT Low are intended for use as a quality control serum to monitor the precision of laboratory testing procedures listed in the package insert. These products do not contain sodium azide as a preservative. They contain a broad-spectrum anti-microbial cocktail as preservatives
{1}------------------------------------------------
- where the concentration of any one ingredient is less than 0.1%. At this low level, these ingredients are not expected to cause a health hazard to the user. And thus, domestic and international regulations do not require this type of information on the vial or box label.
7.0 Comparison of the new device with the Predicate Device
Liquichek Cardiac Markers Plus Controls claims substantial equivalence to the Liquichek™ Cardiac Markers Control LT currently in commercial distribution. The new Liquichek Cardiac Markers Plus Controls contain B-type Natriuretic Peptide (BNP), Creatine Kinase, Total and C-Reactive Protein (CRP). The current product does not contain these analytes.
| Table 1. Similarities and Differences between new and predicate device. | |
|---|---|
| ------------------------------------------------------------------------- | -- |
| Characteristics | Bio-RadLiquichek™ Cardiac Markers Plus Controls(New Device) | Bio-RadLiquichek™ Cardiac Markers Control LT(Predicate Device K040277) |
|---|---|---|
| Intended Use | Liquichek Cardiac Markers Plus Controls are intended for useas a quality control serum to monitor the precision of laboratorytesting procedures listed in the package insert. | Liquichek Cardiac Markers Control LT is intended for use asan assayed quality control serum to monitor the precision oflaboratory testing procedures listed in the package insert. |
| Form | Liquid | Liquid |
| Matrix | Human serum based | Human serum based |
| Differences | ||
| Storage(Unopened) | -20°C to -70°CUntil expiration date | -20°C or colderUntil expiration date |
| Open Vial Claim | 20 days at 2-8°C | All analytes 10 days except NT-proBNP 5 days at 2-8°C |
| Analytes | Contains:B-type Natriuretic Peptide (BNP)Creatine Kinase, TotalC-Reactive Protein (CRP)CK-MB IsoenzymeDigitoxinHomocysteineMyoglobinN-terminal pro-B-type Natriuretic Peptide (NT-pro BNP)Troponin ITroponin T | Contains:CK-MB IsoenzymeDigitoxinHomocysteineMyoglobinN-terminal pro-B-type Natriuretic Peptide (NT-pro BNP)Troponin ITroponin TDoes not containB-type Natriuretic Peptide (BNP)Creatine Kinase, TotalC-Reactive Protein (CRP) |
8.0 STATEMENT OF SUPPORTING DATA
Stability studies have been performed to determine the open vial stability and shelf life for the Liquichek™ Cardiac Markers Plus Control. Product claims are as follows:
- Open vial: All analytes will be stable for 20 days at 2 to 8°C. 8.1
- 8.2 Shelf Life: 3 years at -20°C to -70°C
- 8.3 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.
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing the wings and head. The eagle is facing to the right.
APR 2 7 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Suzanne S. Parsons Regulatory Affairs Specialist Bio-Rad Laboratories, QSD 9500 Jeronimo Road Irvine, CA 92618-2017
Re: K050537
Trade/Device Name: Liquichek™ Cardiac Markers Plus Control Liquchek™ Cardiac Markers Plus Control LT Liquichek™ Cardiac Markers Plus Control LT Low Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: February 22, 2005 Received: March 2, 2005
Dear Ms. Platt:
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).
{3}------------------------------------------------
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)276-0484. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely vours.
Sean M. Coogen, MS, DVM
Jean M. Cooper, MS, 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
{4}------------------------------------------------
Indications for Use
| 510(k) Number (if known): | K050537 |
|---|---|
| Device Name: | Liquichek™ Cardiac Markers Plus Control |
| Indications For Use: | Liquichek Cardiac Markers Plus Control is intended for use as aquality control serum to monitor the precision of laboratory testingprocedures listed in the package insert. |
| Device Name: | Liquichek™ Cardiac Markers Plus Control LT |
| Indications For Use: | Liquichek Cardiac Markers Plus Control LT is intended for use as aquality control serum to monitor the precision of laboratory testingprocedures listed in the package insert. |
| Device Name: | Liquichek™ Cardiac Markers Plus Control LT Low |
| Indications For Use: | Liquichek Cardiac Markers Plus Control LT Low is intended for useas a quality control serum to monitor the precision of laboratorytesting procedures 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 Benson
(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number _ 05705
Page 1 of
§ 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.