(26 days)
Not Found
No
The device description and performance studies focus on the stability and use of a liquid quality control material for laboratory testing, with no mention of AI or ML technologies.
No
The device is described as a quality control material intended to monitor the precision of laboratory testing procedures, not to treat or diagnose patients.
No
This device is a quality control material intended to monitor the precision of laboratory testing procedures, not to diagnose a condition in a patient.
No
The device description clearly states it is a liquid control material prepared from human and animal origin, stabilizers, and preservatives, 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 is for "monitoring the precision of laboratory testing procedures for the analytes listed in this package insert." This is a classic function of an IVD control material.
- Device Description: The description confirms it is a "trilevel liquid control prepared from human protein with added constituents of human and animal origin, stabilizers and preservatives." This material is designed to be used in vitro (outside the body) to assess the performance of diagnostic tests.
- Analytes: The analytes listed (Troponin I and Troponin T) are biomarkers measured in biological samples (like blood) to aid in diagnosis or monitoring of medical conditions.
- Care Setting: The intended user is in "laboratory testing procedures," which is where IVD tests are performed.
The device is a quality control material used with IVD tests, making it an IVD itself.
N/A
Intended Use / Indications for Use
Liquichek Cardiac Troponins Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in this package insert.
- Troponin I
- Troponin T
Product codes (comma separated list FDA assigned to the subject device)
JJY
Device Description
Liquichek Cardiac Troponins Control is a trilevel liquid control prepared from human protein with added constituents of human and animal origin, stabilizers and preservatives. Liquichek Cardiac Troponins Control is intended for use as an assayed quality control to monitor the precision of Troponin I and Troponin T in laboratory testing procedures.
The human source material used to manufacture this control was tested by FDA accepted methods and found non-reactive for Hepatitis B Surface Antigen (HBsAg), antibody to Hepatitis C (HCV) and antibody to HIV-1/HIV-2.
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)
Real-time stability studies were conducted to establish the thawed, opened and frozen Aliquot stability claims. Accelerated stability studies were conducted to establish the shelf-life stability claim. Acceptance Criteria were met to support the product claims as follows:
Thawed and Opened Stability: 25 days at 2 to 8 °C
Frozen Aliquot Stability Studies: 30 days at -20°C to -70 °C
Shelf Life Stability: 18 months at -20°C to -70 °C
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
§ 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.
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Page 1 of 3
510(k) Summary Liquichek Cardiac Troponins Control
1.0 Submitter
Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 Telephone: (949) 598-1200 Fax: (949) 598-1557
Contact Person
Suzanne Parsons Regulatory Affairs Manager Telephone: (949) 598-1467
Date of Summary Preparation
· May 2, 2014
2.0 Device Identification
| Product Trade Name: | Liquichek Cardiac Troponins Control | |
|---|---|---|
| Common Name: | Multi-Analyte Controls, All Kinds (Assayed) | |
| Review Panel: | Clinical Chemistry and Clinical Toxicology Devices | |
| Classifications: | Class I, Reserved | |
| Product Code: | JJY | |
| Regulation Number | 21 CFR 862.1660 |
3.0 Device to Which Substantial Equivalence is Claimed
Liquichek Cardiac Markers Plus Control Bio-Rad Laboratories Irvine, California
510 (k) Number: K050537
4.0 Description of Device
Liquichek Cardiac Troponins Control is a trilevel liquid control prepared from human protein with added constituents of human and animal origin, stabilizers and preservatives. Liquichek Cardiac Troponins Control is intended for use as an assayed quality control to monitor the precision of Troponin I and Troponin T in laboratory testing procedures.
The human source material used to manufacture this control was tested by FDA accepted methods and found non-reactive for Hepatitis B Surface Antigen (HBsAg), antibody to Hepatitis C (HCV) and antibody to HIV-1/HIV-2.
MAT 6 2014
1
5.0 Value Assignment
The mean values and the corresponding ±3SD ranges printed in this insert were derived from multiple replicate analyses that meet acceptance criteria and are specific for the lot of product. The tests listed were performed by the manufacturer and/or independent laboratories using manufacturer supported reagents and a representative sampling of the lot of product. It is recommended that each laboratory establish its own acceptable ranges and use those provided only as quides. Laboratory established ranges may vary from those listed during the life of this control. Variations over time and between laboratories may be caused by differences in laboratory technique, instrumentation and reagents, or by manufacturer test method modifications.
6.0 Intended use
Liquichek Cardiac Troponins Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in this package insert.
7.0 Comparison of the new device with the Predicate Device
The new Liquichek Cardiac Troponins Control claims substantial equivalence to the Liquichek Cardiac Markers Plus Control currently in commercial distribution (K050537). Table 1 (below) contains comparison information of similarities and differences between the new and predicate device to which substantial equivalence is claimed.
(This portion of the page is intentionally left blank.)
2
| Characteristics | Bio-Rad Liquichek Cardiac Troponins Control
(New Device) | Bio-Rad Liquichek Cardiac Markers Plus Control LT
(Predicate Device, K050537) |
|-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | This product is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. | This product is intended for use as a quality control serum to monitor the precision of laboratory testing procedures listed in the package insert. |
| Form | Liquid | Liquid |
| Aliquot Stability | 30 days at -20 to -70 °C | 30 days at -20 to -70 °C |
| Differences | | |
| Matrix | Human Protein | Human Serum |
| Open vial | 25 days at 2 - 8 °C | 20 days at 2 - 8 °C with the following exceptions:
NT-proBNP: 15 days
Troponin I: 10 days
BNP: 8 days
Troponin T: 4 days |
| Shelf life | At -20 to -70 °C until the expiration date | At -20 to -70 °C until the expiration date |
| Analytes | Contains:
Troponin I
Troponin T
Does not contain:
CK Total
CK-MB Isoenzyme
Digitoxin
Homocysteine
CRP
Myoglobin
NT-proBNP
BNP | Contains:
Troponin I
Troponin T
CK Total
CK-MB Isoenzyme
Digitoxin
Homocysteine
CRP
Myoglobin
NT-proBNP
BNP |
Table 1: Similarities and Differences between new and predicate device
8.0 Statement of Supporting Data
Real-time stability studies were conducted to establish the thawed, opened and frozen Aliquot stability claims. Accelerated stability studies were conducted to establish the shelf-life stability claim. Acceptance Criteria were met to support the product claims as follows:
| Thawed and Opened Stability: | 25 days at 2 to 8 °C |
|---|---|
| Frozen Aliquot Stability Studies: | 30 days at -20°C to -70 °C |
| Shelf Life Stability: | 18 months at -20°C to -70 °C |
- 9.0 Conclusion
Based on the performance characteristics indicated above, the Bio-Rad Liquichek Cardiac Troponins Control is substantially equivalent to the predicate device K050537.
All supporting data is retained on file at Bio-Rad Laboratories.
3
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Public Health Service
Food and Drug Ad 10903 New Hame Document Control Ca Silver Spring, MD 20993-0002
May 6, 2014
BIO-RAD LABORATORIES MS SUZANNE PARSONS 9500 JERONIMO RD. IRVINE CA 92618-2017
Re: K140916
Trade/Device Name: Liquichek Cardiac Troponins Control Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: I, Reserved Product Code: JJY Dated: April 08, 2014 Received: April 10, 2014
Dear Ms. Suzanne Parsons:
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 cnactment 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. Please note: CDRH docs not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not miskeading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your cevice 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
4
Page 2-Ms. Parsons
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 80) and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Courtney H. Lias -S
Courtney H. Lias. Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
5
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K140916
Device Name
Liquichek Cardiac Troponins Control
Indications for Use (Describe)
Liguichek Cardiac Troponins Control is intended for use as an assayed quality control server to monitor the precision of laboratory testing procedures for the analytes listed in this package insert.
-
Troponin I
-
Troponin T
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
A. Chesler -
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