(39 days)
Liquichek™ D-dimer Control is intended for use as an assayed quality control to monitor the precision of laboratory testing procedures for D-dimer.
Liquichek™ D-dimer Control is prepared from processed human plasma with added constituents of human and animal origin, and preservatives. The control is provided in liquid form for convenience.
The provided document describes the Bio-Rad Liquichek™ D-dimer Control, a quality control product, and its substantial equivalence to a predicate device. This submission focuses on the product's performance attributes and comparative analysis rather than a traditional medical device (e.g., diagnostic AI algorithm) for which acceptance criteria and a study proving those criteria are typically described.
Therefore, the requested information elements (1-9) which are typically associated with performance studies of diagnostic devices with clinical outcomes, are not directly applicable in the same way to this quality control product. However, I can interpret the provided information to best fit the requested structure, focusing on the stability studies mentioned as the primary "study" performed for this device.
Here's an interpretation based on the provided document:
Acceptance Criteria and Study Details for Liquichek™ D-dimer Control
This submission focuses on establishing the substantial equivalence of a new multi-level quality control product to an existing bi-level product and evaluating its stability. The "performance" being assessed here is the control's stability over time, which is critical for its intended use in monitoring laboratory precision.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly related to the stability claims. The reported performance is the established stability period.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Open Vial Stability: Control maintains its stated D-dimer levels and integrity for a specified period after opening. | 30 days when stored tightly capped at 2 to 25°C. |
| Shelf Life (Unopened Vial Stability): Control maintains its stated D-dimer levels and integrity for a specified period when unopened. | Three years when stored at 2 to 8 °C. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the "sample size" in terms of how many individual vials or batches were tested for the stability studies. However, it indicates:
- Sample Size: Not explicitly stated (e.g., number of batches, number of vials per batch).
- Data Provenance: The studies were performed internally by Bio-Rad Laboratories. The country of origin for the data is not specified, but the submitter is Bio-Rad Laboratories, located in Irvine, California, USA. The studies are prospective as they are described as "stability studies have been performed" and "Real time studies will be ongoing to support the shelf life."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
For a quality control product, "ground truth" and "experts" in the context of clinical interpretation are not directly applicable. The "truth" is established by the analytical methods used to determine the D-dimer levels and the product's stability characteristic.
- Number of Experts: Not applicable in the context of clinical interpretation.
- Qualifications of Experts: Not applicable. The "expertise" lies within the analytical chemistry and quality control professionals at Bio-Rad who designed and executed the stability testing.
4. Adjudication Method for the Test Set
Adjudication methods (e.g., 2+1) are not applicable to the stability testing of a quality control product. The stability is determined through laboratory measurements and statistical analysis against predefined acceptance limits for D-dimer values.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of results, which is not the primary focus for a quality control product.
6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) was Done
While this is not an "algorithm," the stability studies represent a standalone performance assessment of the control material itself, without direct human interpretation of clinical cases within the study design. The "performance" here is the material's ability to maintain its specified characteristics over time.
7. The Type of Ground Truth Used
The "ground truth" for the stability studies is effectively the assigned D-dimer value for each level of the control product and the measured D-dimer levels over time using validated analytical methods. The stability is confirmed if the measured values remain within predefined acceptance limits (which would be internal specifications based on assay precision and clinical relevance). This is akin to using analytical reference values/measurements.
8. The Sample Size for the Training Set
"Training set" is not applicable for a quality control product's stability studies in the way it would be for an AI algorithm. There is no machine learning model being trained. The "training" here would be the development and optimization of the manufacturing process and initial characterization of the product.
9. How the Ground Truth for the Training Set was Established
As "training set" is not applicable in the AI sense, this question is also not directly relevant. The "ground truth" for establishing the initial characteristics of the control (before stability testing) would come from rigorous analytical testing using reference methods and potentially comparison to international standards for D-dimer measurement. These assigned values then form the basis against which stability is assessed.
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AUG - 8 2003
Page 1 of 2
Summary of Safety and Effectiveness Liquichek™ D-dimer Control
1.0 Submitter
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: (949) 598-1367
Date of Summary Preparation
June 26, 2003
2.0 Device Identification
| Product Trade Name: | Liquichek™ D-dimer Control |
|---|---|
| Common Name: | Plasma, Coagulation Control |
| Classifications: | Class II |
| Product Code: | GGN |
| Regulation Number: | CFR 862.5425 |
3.0 Device to Which Substantial Equivalence is Claimed
Liquichek™ D-dimer Control Bio-Rad Laboratories Irvine, California
510(k) Number: K030182
4.0 Description of Device
Liquichek™ D-dimer Control is prepared from processed human plasma with added constituents of human and animal origin, and preservatives. The control is provided in liquid form for convenience.
5.0 Statement of Intended Use
Liquichek™ D-dimer Control is intended for use as an assayed quality control to monitor the precision of laboratory testing procedures for D-dimer.
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6.0 Comparison of the new device with the Predicate Device
The new Liquichek™ D-dimer Control claims substantial equivalence to the Liquichek™ D-dimer Control currently in commercial distribution (K030182). The new Liquichek™ Ddimer Control is a tri-level (Level 1, 2 and 3) product and the current product is a bi-level (Level 1 and 2) product.
| Bio-Rad | Bio-Rad | |
|---|---|---|
| Characteristics | Liquichek™ D-dimer Control | Liquichek™ D-dimer Control |
| (New Device) | (Predicate Device K030182) | |
| Similarities | ||
| Intended Use | Liquichek D-dimer Control is intended for useas a quality control to monitor the precision ofD-dimer procedures. | Liquichek D-dimer Control is intended for useas a quality control to monitor the precision ofD-dimer procedures. |
| Analytes | D-dimer | D-dimer |
| Storage(Unopened) | 2°C to 8°CUntil expiration date | 2°C to 8°CUntil expiration date |
| Matrix | Processed human plasma with addedconstituents of human and animal origin, andpreservatives. | Processed human plasma with addedconstituents of human and animal origin, andpreservatives. |
| Open Vial Claim | 30 days at 2 to 25°C | 30 days at 2 to 25°C |
| Form | Liquid | Liquid |
| Differences | ||
| Levels | Level 1, 2 and 3 | Level 1 and 2 (Does not have a Level 3product) |
| Analyte D-dimerLevels | Level 3: 4.5 - 5.5 ug FEU/mL | Level 1: 0.22 - 0.4 ug FEU/mL |
| Level 2: 1.5 - 2.5 ug FEU/mL |
Table 1. Similarities and Differences between new and predicate device.
7.0 Statement of Supporting Data
Stability studies have been performed to determine the open vial stability and shelf life for the Liquichek™ D-dimer Control. Product claims are as follows:
- 7.1 Open vial: Once the product is opened, the analyte will be stable for 30 days when stored tightly capped at 2 to 25°C.
- 7.2 Shelf Life: Three years when stored at 2 to 8 °C.
Real time studies will be onqoing to support the shelf life of this product.
All supporting data is retained on file at Bio-Rad Laboratories.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular, with the text "DEPARTMENT FOR HEALTH & HUMAN SERVICES USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of an eagle or bird-like figure, composed of three curved lines.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG - 8 2003
Ms. Maria Zeballos Regulatory Affairs Specialist Bio-Rad Laboratories 9500 Jeronimo Road Irvine, California 92618-2017
Re: K032017 Trade/Device Name: Liquichek™M D-dimer Control Regulation Number: 21 CFR § 864.5425 Regulation Name: Multipurpose System for in vitro coagulation studies Regulatory Class: II Product Code: GGN Dated: June 26, 2003 Received: July 1, 2003
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 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). 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.
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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 (301) 594-3084. 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/dsma/dsmamain.html.
Sincerely yours,
steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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510 (k) Number (if known):
Liquichek™ D-dimer Control Device Name:
Indications for Use:
Liquichek D-dimer Control is intended for use as an assayed quality control to monitor the precision of laboratory testing procedures for D-dimer.
Methods:
- bioMerieux Vidas .
- Dade Behring BCS/BCT Advanced D-Dimer ●
- Dade Behring Stratus CS ●
- Dade Behring Sysmex Series Advanced D-Dimer ●
- Diagnostica Stago Sta/Sta-R/Sta-Compact LIATEST ●
- IL ACL Series ●
- Roche Cobas Integra 400/800 Tina-quant .
- Roche Hitachi Tina-quant .
510(k)
(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 |
|---|---|---|---|
| ------------------ | -------------------------------------------- | ---- | ---------------------- |
Saitte Y. Michael O MD FOR J. BAUTISTA
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K032017
§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.