(53 days)
Not Found
No
The device is a quality control serum for laboratory testing procedures and the description focuses on its stability and equivalence to a predicate device. There is no mention of AI or ML.
No
This device is a quality control serum used to monitor the precision of laboratory testing procedures, not to treat a condition.
No
This device is a quality control substance used to monitor the precision of laboratory testing procedures, not to diagnose a condition.
No
The device is a lyophilized serum, which is a physical substance, not software.
Based on the provided information, 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 the analytes listed in the package insert." This aligns with the definition of an IVD, which is used to examine specimens derived from the human body to provide information for diagnostic purposes. While this specific device is a control material and not directly used to diagnose a patient, it is an essential component within the IVD testing process.
- Device Description: It is described as a "quality control serum" and "quality control material" used to "monitor the precision of laboratory testing procedures." Quality control materials are a standard part of IVD testing to ensure the accuracy and reliability of the diagnostic tests being performed.
- Predicate Device: The predicate device (K011579; Lyphochek Tumor Marker Control) is also a quality control material for tumor markers, which are typically measured using IVD tests. The fact that it's being compared to a predicate device with a 510(k) number further indicates its classification as a medical device, and specifically an IVD in this context.
- Intended User/Care Setting: The intended user is "laboratory testing procedures," which is the environment where IVD tests are performed.
In summary, while the device itself doesn't directly diagnose a patient, it is a critical component used in vitro (outside the body) within the laboratory setting to ensure the accuracy and reliability of diagnostic tests for tumor markers. This function firmly places it within the category of In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
Lyphochek Tumor Marker Plus 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.
Product codes (comma separated list FDA assigned to the subject device)
JJY
Device Description
Not Found
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 shelf life at 2 to 8°C, reconstituted at 2 to 8°C and reconstituted frozen at -20 to -70°C. Product claims are as follows:
- 8.1 Shelf Life at 2 to 8°C, all analytes will be stable for 3 years.
- 8.2 Reconstituted Stability at 2 to 8°C: Once the control is reconstituted, all analytes will be stable for 14 days when stored tightly capped at 2 to 8°C, with the following exceptions: Carcinoembryonic Antigen (CEA) will be stable for 11 days; Free and Total PSA will be stable for 7 days: Thyroqlobulin (Tg) will be stable for 5 days; ACTH and Calcitonin should be assayed immediately following reconstitution.
- 8.3 Reconstituted Stability at -20 to -70°C: All analytes will be stable for 30 days after the control is reconstituted and stored tightly capped at -20 to -70℃. After use, discard the remaining material. There are no stability claims at -20 to -70°C for ACTH and Calcitonin.
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
Bio-Rad Laboratories Lyphochek Tumor Marker Plus Control Premarket Notification Section 510(k)
1.0 DEVICE INFORMATION
| Product Name: | Lyphochek Tumor Marker Plus Control |
|---|---|
| Common Name: | Clinical Chemistry Test Systems |
| : | Quality control material (assayed and unassayed) |
2.0 MEDICAL DEVICE ESTABLISHMENT
| Manufacturing Facility: | Bio-Rad Laboratories |
|---|---|
| Address: | 9500 Jeronimo Road |
| Irvine, California 92618 | |
| Telephone: | |
| Fax: | 949-598-1200 |
| 949-598-1557 |
Establishment Registration No .: 2016706
3.0 DEVICE Class
| Classification: | Class I |
|---|---|
| Product Code: | JJY |
| Regulation Number: | 21 CFR 862.1660 |
4.0 Performance Standards
None Require
5.0 PROPOSED LABELING
Included in this 510(k) notification is a copy of the proposed Lyphochek Tumor Marker Plus Control vial, box and insert labels (Appendices 3, 4 and 5).
6.0 STATEMENT OF SUBSTANTIAL EQUIVALENCE
Lyphochek Tumor Marker Plus Control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. This control is substantially equivalent to the following quality control material that is currently in the market:
Lyphochek Tumor Marker Control Bio-Rad Laboratories Irvine, California 92618
510(k) Number: K011579
A copy of the product insert for the above product can be found in Appendix 7.
02_510(k) Lyp Tumor Markers_Plus_367 08/08
1
7.0 Comparison of the new device with the Predicate Device
Lyphochek Tumor Marker Plus Control claims substantial equivalence to the Lyphochek Tumor Marker Control currently in commercial distribution (K011579).
| Table 1. Similarities and Differences between new and predicate device. | ||
|---|---|---|
| Bio-Rad Laboratories | Bio-Rad Laboratories | |
| Characteristics | Lyphochek Tumor Marker Plus Control | |
| (New Device) | Lyphochek Tumor Marker Control | |
| (Predicate Device) | ||
| Similarities | ||
| Intended Use | Lyphochek Tumor Marker Plus 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. | Lyphochek 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. | ||
| Storage (Unopened) | 3 Years at 2 to 8°C | 3 Years at 2 to 8°C |
| Reconstitute & Store | ||
| at -20 to -70°C: | All analytes will be stable for 30 days at -20 to -70°C. There | |
| are no stability claims at -20 to -70°C for ACTH and | ||
| Calcitonin. | All analytes will be stable for 30 days at -10 to -20°C with the | |
| following exception: NSE will be stable for 7 days. | ||
| Form | Lyophilized | Lyophilized |
| Matrix | Serum | Serum |
| Differences | ||
| Levels | 1, 2 and 3 | 1 and 2 |
| Reconstitute & Store | ||
| at 2 to 8°C | All analytes will be stable for 14 days at 2 to 8°C, with the | |
| following exceptions: | ||
| • Carcinoembryonic Antigen (CEA) is stable for 11 days. | ||
| • Free and Total PSA is stable for 7 days. | ||
| • Thyroglobulin (Tg) is stable for 5 days. | ||
| • ACTH and Calcitonin should be assayed immediately. | All analytes will be stable for 14 days at 2 to 8°C, with the | |
| following exceptions: | ||
| • Ferritin and CA 27-29 will be stable for 6 days; | ||
| • NSE will be stable for 3 days. | ||
| • ACTH, Free PSA, PSA, and Calcitonin should be assayed | ||
| immediately following reconstitution. | ||
| Analytes | Contains Claims for the following: | |
| • Adrenocorticotropic Hormone (ACTH) | ||
| • Alpha Fetoprotein (AFP) | ||
| • Aldosterone | ||
| • Beta-2-Microglobulin | ||
| • CA 15-3 | ||
| • CA 19-9 | ||
| • CA 27.29 | ||
| • CA 125 | ||
| • Calcitonin | ||
| • Carcinoembryonic Antigen (CEA) | ||
| • Ferritin | ||
| • hCG Beta Subunit (β-hCG)/ hCG | ||
| • Prostatic Acid Phosphatase (PAP) | ||
| • Prolactin | ||
| • Prostate Specific Antigen, Total (PSA) | ||
| • Prostate Specific Antigen, Free (Free PSA) | ||
| • Thyroglobulin (Tg) | Contains Claims for the following: | |
| • Adrenocorticotropic Hormone (ACTH) | ||
| • Alpha Fetoprotein (AFP) | ||
| • Aldosterone | ||
| • Beta-2-Microglobulin (B2-M) | ||
| • CA 15-3 | ||
| • CA 19-9 | ||
| • CA 27.29 | ||
| • CA 50 | ||
| • CA 72-4 | ||
| • CA 125 | ||
| • Calcitonin | ||
| • Carcinoembryonic Antigen (CEA) | ||
| • CASA | ||
| • Cyfra 21-1 | ||
| • Ferritin | ||
| • Human Chorionic Gonadotropin (hCG) | ||
| • Human Chorionic Gonadotropin Beta Subunit (β-hCG) | ||
| • Neuron Specific Enolase (NSE) | ||
| • Prostatic Acid Phosphatase (PAP) | ||
| • Prolactin | ||
| • Prostate Specific Antigen, Total (Total PSA) | ||
| • Prostate Specific Antigen, Free (Free PSA) | ||
| Does not contain claims for the following: | ||
| • CA 50 | ||
| • CA 72-4 | ||
| • CASA | ||
| • Cyfra 21-1 | No claim is made for performance or stability |
new and predicate device Table 1 Similarities and Differences betwee
2
8.0 STATEMENT OF SUPPORTING DATA
Stability studies have been performed to determine the shelf life at 2 to 8°C, reconstituted at 2 to 8°C and reconstituted frozen at -20 to -70°C. Product claims are as follows:
- 8.1 Shelf Life at 2 to 8°C, all analytes will be stable for 3 years.
- 8.2 Reconstituted Stability at 2 to 8°C: Once the control is reconstituted, all analytes will be stable for 14 days when stored tightly capped at 2 to 8°C, with the following exceptions: Carcinoembryonic Antigen (CEA) will be stable for 11 days; Free and Total PSA will be stable for 7 days: Thyroqlobulin (Tg) will be stable for 5 days; ACTH and Calcitonin should be assayed immediately following reconstitution.
- 8.3 Reconstituted Stability at -20 to -70°C: All analytes will be stable for 30 days after the control is reconstituted and stored tightly capped at -20 to -70℃. After use, discard the remaining material. There are no stability claims at -20 to -70°C for ACTH and Calcitonin.
All supporting data is retained on file at Bio-Rad Laboratories.
.. ... .......................................................................................................................................................................
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three tails, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circle around the eagle. The eagle is black, and the text is also black.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP - 8 2008
Bio-Rad Laboratories c/o Ms. Elizabeth Platt 9500 Jeronimo Road Irvine, California 92618-2017
Re: K082036
Trade/Device Name: Lyphochck Tumor Marker Plus Control Regulation Number: 21 CFR §862.1660 Regulation Name: Quality Control Material (assayed and unassayed) Regulatory Class: Class I reserved Product Code: JJY Dated: July 1, 2008 Received: July 17, 2008
Dear Ms. Platt:
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 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 Part 801); 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.
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
4
Page 2- Bio-Rad Laboratories
marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)). please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Maria Mchen
Maria M. Chan, Ph.D. Acting Division Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for Use
K 082036 510(k) Number (if known):
Device Name:
Indications For Use:
Lyphochek Tumor Marker Plus 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.
Domestic Analytes Listed
-
· Adrenocorticotropic Hormone (ACTH)
Lyphochek Tumor Marker Plus Control -
· Alpha Fetoprotein (AFP)
-
· Aldosterone
-
· Beta-2-Microglobulin (B2M)
-
· CA 15-3
-
· CA 19-9
-
· CA 27.29
-
· CA 125
-
· Calcitonin
-
· Carcinoembryonic Antigen (CEA)
-
· Ferritin
-
· hCG Beta Subunit (ß-hCG)/ hCG
-
· Prostatic Acid Phosphatase (PAP)
-
· Prolactin
-
· Prostate Specific Antigen, Total ( PSA)
-
· Prostate Specific Antigen, Free (Free PSA)
-
· Thyroglobulin (Tg)
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Reena Philip
Division Sign-Off
ice of In Vitro Diagnostic e Evaluation and Safety
Page 1 of
510(k) K082036