(39 days)
Not Found
No
The document describes a quality control material for laboratory testing, not a device that processes data or images using AI/ML. There are no mentions of AI, ML, or related concepts.
No.
This device is an assayed quality control used to monitor the precision of laboratory testing procedures, not to treat a medical condition.
No
This device is a quality control for D-dimer testing procedures, not a device used to diagnose a patient. Its intended use is to monitor the precision of laboratory testing procedures, not to provide diagnostic information about a disease or condition.
No
The device description clearly states it is a liquid control material prepared from processed human plasma, indicating it is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "monitoring the precision of laboratory testing procedures for D-dimer." This is a classic function of a quality control material used in laboratory testing.
- Device Description: It's a "quality control" prepared from biological materials (human plasma) with added constituents and preservatives, provided in liquid form. This aligns with the description of a reagent or material used in in vitro diagnostic testing.
- Intended User / Care Setting: It's intended for "laboratory testing procedures," which is the setting where IVD tests are performed.
While it doesn't directly diagnose a disease, it is a crucial component used in conjunction with an IVD test to ensure the accuracy and reliability of the results. Quality controls are considered IVDs because they are used in vitro (outside the body) to assess the performance of other IVD devices.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GGN
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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:
- Open vial: Once the product is opened, the analyte will be stable for 30 days when stored tightly capped at 2 to 25°C.
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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.
1
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 use | |
| as a quality control to monitor the precision of | ||
| D-dimer procedures. | Liquichek D-dimer Control is intended for use | |
| as a quality control to monitor the precision of | ||
| D-dimer procedures. | ||
| Analytes | D-dimer | D-dimer |
| Storage | ||
| (Unopened) | 2°C to 8°C | |
| Until expiration date | 2°C to 8°C | |
| Until expiration date | ||
| Matrix | Processed human plasma with added | |
| constituents of human and animal origin, and | ||
| preservatives. | Processed human plasma with added | |
| constituents of human and animal origin, and | ||
| preservatives. | ||
| 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 3 |
| product) | ||
| Analyte D-dimer | ||
| Levels | 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.
2
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.
3
Page 2 -
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
4
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