(29 days)
Not Found
No
The device description and intended use clearly indicate that this is a quality control serum for laboratory testing, not a device that processes data or images using AI/ML. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".
No
The document explicitly states the device is intended for use as an "assayed quality control serum to monitor the precision of laboratory testing procedures", not for treating any medical condition.
No
Explanation: This device is a quality control substance used to monitor the precision of laboratory testing procedures, not to diagnose a disease or condition in a patient.
No
The device is a quality control serum, which is a physical substance used in laboratory testing, not a software application.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "monitoring the precision of laboratory testing procedures for the analytes listed." This is a classic function of an IVD, specifically a quality control material used in laboratory testing.
- Device Description: It's a "quality control serum" prepared from human serum with added components, designed to be used in laboratory tests.
- Analytes: It contains specific analytes (Erythropoietin, Procalcitonin, Intact Parathyroid Hormone, Sex Hormone Binding Globulin, Vitamin D) that are measured in laboratory tests to assess a patient's health status.
- Testing for Infectious Agents: The mention of testing the human donor units for HBsAg, HCV, and HIV-1/HIV-2 is a common requirement for IVD products derived from human blood or serum to ensure safety.
- Intended User/Care Setting: "laboratory testing procedures" indicates it's used in a laboratory setting, which is where IVD tests are performed.
- Predicate Device: The mention of a predicate device (Liquichek Specialty Immunoassay Control) with a K number (K043108) strongly suggests this device is being submitted for regulatory clearance as an IVD, likely under the 510(k) pathway.
All these factors align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Lyphochek Specialty Immunoassay 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.
Product codes (comma separated list FDA assigned to the subject device)
JJY
Device Description
Lyphochek Specialty Immunoassay Control is prepared from human serum with added chemicals, stabilizers, and preservatives. The control is provided in lyophilized form and contains the following analytes: Erythropoietin (EPO), Procalcitonin, Intact Parathyroid Hormone (Intact PTH), Sex Hormone Binding Globulin (SHBG), Vitamin D. Each human donor unit 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
Laboratory testing procedures
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 performed to establish reconstituted/open vial stability and frozen aliquot stability. Accelerated stability studies were performed for establishing the shelf life stability. The stabilities for Lyphochek Specialty Immunoassay Control are as follows:
Reconstituted Vial Stability: Intact Parathyroid Hormone (Intact PTH): 12 days at 2°C to 8°C; Procalcitonin: 3 days at 2°C to 8 °C; Erythropoietin (EPO), Sex Hormone Binding Globulin (SHBG) and Vitamin D: 30 days at 2 to 8°C.
Frozen Aliquot Stability: 30 days at -20°C to -70°C.
Shelf Life Stability: 36 Months at 2 to 8°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.
0
510(k) Summary
This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirement 21 CFR 807.92
Lyphochek Specialty Immunoassay Control . 510(k) Number: K133960
1.0 Submitter
Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 Telephone: (949) 598-1200 · (949) 598-1557 Fax:
Contact Person
Suzanne Parsons Regulatory Affairs Manager Telephone: (949) 598-1467
Email: Suzanne Parsons@bio-rad.com
Date of Summary Preparation
January 10, 2014
2.0 Device Identification
Product Trade Name: Common Name: Classifications: Product Code: Regulation Number:
Lyphochek Specialty Immunoassay 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 Specialty Immunoassay Control
510(k) Number: K043108
1
' 4.0 Intended Use
Lyphochek Specialty Immunoassay 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.
Description of Device 5.0
Lyphochek Specialty Immunoassay Control is prepared from human serum with added chemicals, stabilizers, and preservatives. The control is provided in lyophilized form and contains the following analytes:
- Erythropoietin (EPO) .
- Procalcitonin .
- . Intact Parathyroid Hormone (Intact PTH)
- Sex Hormone Binding Globulin (SHBG) .
- Vitamin D .
Each human donor unit 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.
Product Configurations
| Description | Configuration |
|---|---|
| Lyphochek Specialty Immunoassay Control, Level 1 | 6 x 2 mL |
| Lyphochek Specialty Immunoassay Control, Level 2 | 6 x 2 mL |
| Lyphochek Specialty Immunoassay Control, Level 3 | 6 x 2 mL |
| Lyphochek Specialty Immunoassay Control, Trilevel MiniPak | 3 x 2 mL |
6.0 Value Assignment
The mean values and the corresponding ±3SD ranges indicated on the control value sheet provided for Lyphockek Specialty Control were derived from replicate analyses and are specific for each lot of product. The tests listed on the control value sheet 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 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.
7.0 Comparison of the new device with the Predicate Device
Lyphochek Specialty Immunoassay Control claims substantial equivalence to the Liquichek Specialty Immunoassay Control currently in commercial distribution (K043108): The table below contains comparison information of similarities and differences between the new and predicate device to which substantial equivalence is claimed.
2
| Characteristics | Lyphochek Specialty Immunoassay Control
(Candidate Device) | Liquichek Specialty Immunoassay Control
(Predicate Device, K043108) |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | Lyphochek Specialty Immunoassay Control 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. | Liquichek Specialty Immunoassay Control
is intended for use as a quality control
serum to monitor the precision of laboratory
testing procedures for the analytes listed in
this package insert. |
| Matrix | Human Serum | Human Serum |
| Preservatives | Contains preservatives | Contains preservatives |
| Stabilizers | Contains stabilizers | Contains stabilizers |
| Differences | | |
| Form | Lyophilized | Liquid |
| Storage unopened (Shelf
life) | 2 to 8°C until expiration date | -20 to -70°C until expiration date |
| Reconstituted / Opened Vial
Stability | 30 days at 2°C to 8 °C
Except: Intact PTH: 12 days at 2°C to
8 °C
Procalcitonin: 3 days at 2°C
to 8 °C | 30 days at 2°C to 8 °C
Except: Intact PTH: 23 days at 2 to
8°C |
| Fill Volume | 2 mL | 5 mL |
| | MiniPak: Trilevel - 3 x 2 mL | MiniPak: Four level - 4 x 5 mL |
| Frozen Aliquot stability | All analytes : 30 days at -20°C to -70°C | No Claim |
| Analytes | Contains:
Erythropoietin (EPO) Procalcitonin Intact Parathyroid Hormone (Intact PTH) Sex Hormone Binding Globulin (SHBG) Vitamin D Does not contain: Anti-Thyroglobulin (Anti-Tg) Anti-Thyroperoxidase (Anti-TPO) C-Peptide Insulin Like Growth Factor I (IGF-I) Osteocalcin | Contains:
Anti-Thyroglobulin (Anti-Tg) Anti-Thyroperoxidase (Anti-TPO) C-Peptide Insulin Like Growth Factor I (IGF-I) Intact Parathyroid Hormone (Intact PTH) 25-OH Vitamin D Osteocalcin Erythropoietin (EPO) Does not contain: Procalcitonin Sex Hormone Binding Globulin (SHBG) |
Similarities and Differences between new and predicate device
· ·
r
·
3
8.0 Stability
Real time stability studies were performed to establish reconstituted/open vial stability and frozen aliquot stability. Accelerated stability studies were performed for establishing the shelf life stability. The stabilities for Lyphochek Specialty Immunoassay Control are as follows:
| | Reconstituted Vial Stability: Intact Parathyroid Hormone (Intact PTH): 12 days at 2°C to 8°C
Procalcitonin: 3 days at 2°C to 8 °C
Erythropoietin (EPO), Sex Hormone Binding Globulin (SHBG)
and Vitamin D: 30 days at 2 to 8°C |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Frozen Aliquot Stability: | 30 days at -20°C to -70°C |
| Shelf Life Stability: | 36 Months at 2 to 8°C |
9.0 Conclusion
Based on the performance characteristics indicated above, Lyphochek Specialty Immunoassay Control is substantially equivalent to the predicate device (K043108).
All supporting data is retained on file at Bio-Rad Laboratories.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 22, 2014
BIO-RAD LABORATORIES SUZANNE PARSONS REGULATORY AFFAIRS MANAGER 9500 JERONIMO RD. IRVINE CA 92618-2017
Re: K133960
Trade/Device Name: Lyphochek Specialty Immunoassay Control Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: I Reserved Product Code: JJY Dated: December 20, 2013 Received: December 24, 2013
Dear Ms. 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 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 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.
5
Page 2-Ms. Parsons
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809). please contact the Division of Small Manufacturers, International and Consumer Assistance 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" (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/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 Small Manufacturers, International and Consumer Assistance 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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) K133960
Device Name
Lyphochek Specialty Immunoassay Control
Indications for Use (Describe)
Lyphochek Specialty Immunoasay 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.
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)
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FORM FDA 3881 (1/14)
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