(74 days)
Not Found
No
The summary describes a quality control serum for laboratory testing, with no mention of AI or ML technologies.
No.
The device is a quality control serum used to monitor the precision of laboratory testing procedures, not to treat a disease or condition.
No
The device is a quality control serum used to monitor the precision of laboratory testing procedures, not to diagnose a disease in a patient.
No
The device is a quality control serum, which is a physical substance used in laboratory testing, not a software application.
Based on the provided information, 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 the analytes listed in this package insert." This is a classic function of a quality control material used in laboratory testing.
- Device Description: It's a "quality control serum" prepared from biological materials, designed to be used in laboratory settings.
- Intended User / Care Setting: It's intended for "Laboratory testing procedures," which is where IVDs are used.
While it doesn't directly diagnose a disease, it's a crucial component in ensuring the accuracy and reliability of diagnostic tests performed in a laboratory. Quality control materials like this are considered IVDs because they are used in vitro (outside the body) to evaluate the performance of other diagnostic devices or procedures.
N/A
Intended Use / Indications for Use
Liquichek Tumor Marker Control is intended for use as an assayed quality control serum to moni tor the precision of laboratory testing procedures for the analytes listed in this package insert.
Product codes
JJY
Device Description
Liquichek Tumor Marker Control is prepared from human source material with added constituents of human and animal origin, chemicals, stabilizers and preservatives. The control is provided in liquid form for convenience.
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
Real time stability studies were performed to establish Thawed and Opened. Thawed and unopened and Frozen Aliquot stability claims. Accelerated stability studies were performed for establishing the stability. The stabilities for Liquichek Tumor Marker Control are as follows
Thawed and Opened Stability: IGF-1: 15 days at 2 to 8°C, CA 125: 10 days at 2 to 8°C, All other analytes: 30 days at 2 to 8°C
Thawed and Unopened Stability: IGF-I, PAP: 35 days at 2 to 8°C, Free PSA: 30 days at 2 to 8°C, CA 125: 14 days at 2 to 8°C, All other analytes: 60 days at 2 to 8°C
Frozen Aliquot Stability: All analytes: 30 days at -20°C to -70°C
Shelf Life stability: 28 months at -20 to -70°C
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 11, 2017
BIO-RAD LABORATORIES SUZANNE PARSONS REGULATORY AFFAIRS MANAGER 9500 JERONIMO ROAD IRVINE CA 92618-2017
Re: K163015
Trade/Device Name: Liquichek Tumor Marker Control-level 1; Liquichek Tumor Marker Control-level 2; Liquichek Tumor Marker Control-level 3; Liquichek Tumor Marker Control- Trilevel Minipak Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: I, Reserved Product Code: JJY Dated: October 26, 2016 Received: October 28, 2016
Dear Ms. Parsons:
This letter corrects our substantially equivalent letter of January 10, 2017.
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 device 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
1
as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportaProblem/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,
Kelly Oliner -S
For
Leonthena Carrington, MBA, MS, MT(ASCP) Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K163015
Device Name Liquichek Tumor Marker Control
Indications for Use (Describe)
Liquichek Tumor Marker Control is intended for use as an assayed quality control serum to moni tor the precision of laboratory testing procedures for the analytes listed in this package insert.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
3
510(k) Summarv
Liquichek Tumor Marker Control
1.0 Submitter
Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 (949) 598-1200 Telephone: (949) 598-1557 Fax:
Contact Person
Suzanne Parsons RA/QA Supervisor Telephone: (949) 598-1467
Date of Summary Preparation
January 3rd 2017
2.0 Device Identification
Product Trade Name: Common Name: Classifications: Product Code: Requlation Number:
Liquichek Tumor Marker Control Multi-Analyte Controls, All Kinds (Assayed) Class I, Reserved JJY 21 CFR 862.1660
3.0 Device to Which Substantial Equivalence is Claimed
Liquichek Tumor Marker Control Bio-Rad Laboratories Predicate 510(k) Number: K071675
4.0 Description of Device
Liquichek Tumor Marker Control is prepared from human source material with added constituents of human and animal origin, chemicals, stabilizers and preservatives. The control is provided in liquid form for convenience.
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.
5.0 Value Assignment
The mean values and corresponding ±3SD ranges in the Assignment of Values Data Charts were derived from replicate analyses and are specific for this lot of product. Data from Unity™ Interlaboratory Program are included in the determination of some ranges.
4
The tests listed were performed by the manufacturer and/or independent laboratories using manufacturer supported reagents and a representative sampling of this lot of product. It is recommended that each laboratory establish its own acceptable ranges and use those provided only as guides. 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 Tumor Marker 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
Liquichek Tumor Marker Control claims substantial equivalence to Liquichek Tumor Marker Control (K071675). Table 1 (below) contains comparison information of similarities and differences between the new and predicate device to which substantial equivalence is claimed.
| Characteristics | Liquichek Tumor Marker Control
(New Device) | Liquichek Tumor Marker Control
(Predicate Device, K071675) |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | Liquichek Tumor Marker 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. | Liquichek Tumor Marker 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. |
| Matrix | Human source material and constituents of
animal origin | Human source material and constituents of
animal origin |
| Form | Liquid | Liquid |
| Storage unopened
(Shelf life) | -20°C to -70°C until expiration date | -20°C to -70°C until expiration date |
| Thawed Unopened
Stability | All analytes: 60 days at 2 to 8°C | All analytes: 60 days at 2 to 8°C |
| | Except IGF-I, PAP: 35 days at 2 to 8°C | Except IGF-I, PAP: 35 days at 2 to 8°C |
| | Free PSA: 30 days at 2 to 8°C | Free PSA: 30 days at 2 to 8°C |
| | CA 125: 14 days at 2 to 8°C | CA 125: 14 days at 2 to 8°C |
| Thawed Opened
Stability | All analytes: 30 days at 2 to 8°C | All analytes: 30 days at 2 to 8°C |
| | Except IGF-1: 15 days at 2 to 8°C | Except IGF-1: 15 days at 2 to 8°C |
| | CA 125: 10 days at 2 to 8°C | CA 125: 10 days at 2 to 8°C |
| Fill Volume | Level 1, 2 and 3 – 6 x 2 mL | Level 1, 2 and 3 – 6 x 2 mL |
| | Trilevel MiniPak - 3 x 2 mL | Trilevel MiniPak - 3 x 2 mL |
| Differences | | |
| Frozen aliquot | 30 days at -20 to -70 °C | No Claim |
Table 1. Similarities and Differences between new and predicate device.
5
| Analytes | Contains: | Contains: |
|---|---|---|
| Alpha Fetoprotein (AFP) Beta-2-Microglobulin (B2-M) CA 15-3 CA 19-9 CA 27.29 CA 125 Carcinoembryonic Antigen (CEA) Ferritin Her-2/neu Human Chorionic Gonadotropin (hCG)/(β-hCG, Total hCG, Intact hCG) Human Epididymis Protein 4 (HE4) Insulin-like Growth Factor-I (IGF-1) Prostatic Acid Phosphatase (PAP) Prolactin Prostate Specific Antigen, Total (Total PSA) Prostate Specific Antigen, Free (Free PSA) Thyroglobulin (Tg) | Alpha Fetoprotein (AFP) Beta-2-Microglobulin (B2-M) CA 15-3 CA 19-9 CA 27.29 CA 125 Carcinoembryonic Antigen (CEA) Ferritin Human Chorionic Gonadotropin (hCG)/(β-hCG, Total hCG, Intact hCG) Insulin-like Growth Factor-I (IGF-1) Prostatic Acid Phosphatase (PAP) Prolactin Prostate Specific Antigen, Total (Total PSA) Prostate Specific Antigen, Free (Free PSA) Thyroglobulin (Tg) Does not Contain: Her-2/neu Human Epididymis Protein 4 (HE4) |
8.0 Statement of Supporting Data
Real time stability studies were performed to establish Thawed and Opened. Thawed and unopened and Frozen Aliquot stability claims. Accelerated stability studies were performed for establishing the stability. The stabilities for Liquichek Tumor Marker Control are as follows
| Thawed and Opened Stability | IGF-1: 15 days at 2 to 8°C
CA 125: 10 days at 2 to 8°C
All other analytes: 30 days at 2 to 8°C |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Thawed and Unopened Stability | IGF-I, PAP: 35 days at 2 to 8°C
Free PSA: 30 days at 2 to 8°C
CA 125: 14 days at 2 to 8°C
All other analytes: 60 days at 2 to 8°C |
| Frozen Aliquot Stability | All analytes: 30 days at -20°C to -70°C |
| Shelf Life stability: | 28 months at -20 to -70°C |
9.0 Conclusion
Based on the performance characteristics indicated above, Liquichek Tumor Marker Control is substantially equivalent to the predicate device (K071675).
All supporting data is retained on file at Bio-Rad Laboratories.