(35 days)
Not Found
No
The summary describes a quality control serum for laboratory testing, with no mention of AI or ML in the device description, intended use, or performance studies.
No
This device is a quality control serum used to monitor the precision of laboratory testing procedures, not to treat a patient.
No
Explanation: This device is described as an "assayed quality control serum" used to "monitor the precision of laboratory testing procedures." Its purpose is to ensure the accuracy of other tests, not to diagnose a patient's condition directly.
No
The device description clearly states it is a lyophilized serum control, which is a physical substance, not software.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "An assayed quality control serum to monitor the precision of laboratory testing procedures for analytes listed in the package insert." This clearly indicates the device is used in vitro (outside the body) to assess the performance of laboratory tests.
- Device Description: The description states it's "prepared from human serum with added constituents... provided in lyophilized form". This is a typical description of a reagent or control used in laboratory testing.
- Intended User / Care Setting: The intended user is "laboratory testing procedures", further reinforcing its use in a laboratory setting for diagnostic purposes.
While the device itself doesn't directly diagnose a patient, it is 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 to evaluate the performance of other IVD devices or procedures.
N/A
Intended Use / Indications for Use
Lyphochek® Tumor Marker Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for analytes listed in this package insert.
Product codes
75JJY
Device Description
Lyphochek® Tumor Marker Control is prepared from human serum with added constituents of human origin and pure chemicals. The control is provided in lyophilized form for increased stability
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
Stability studies have been performed to determine the open vial stability and shelf life for the Lyphochek® Tumor Marker Control. Product claims are as follows:
- Once the control is reconstituted, all analytes will be stable for 14 days when stored tightly capped at 2 - 8°C, with the following exceptions: Ferritin and CA 27-29 will be stable for 6 days. ACTH, Free PSA, PSA, PSA, and Calcitonin should be assayed immediately following reconstitution. For optimum precision of Ferritin, allow vial to equilibrate for a minimum of 2 hours prior to assay.
- After reconstituting and freezing the control, all analytes will be stable for 30 days when stored tightly capped at -10℃ to -20 ℃. Once thawed, do not refreeze the control; discard remaining material.
- The control is stable for 3 years and 3 months when stored unopened at 2 - 8°C.
Real time studies will be ongoing to support the shelf life of this product. All supporting data is retained on file at Bio-Rad Laboratories.
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.
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JUN 2 6 2001
Summary of Safety and Effectiveness Lyphochek® Tumor Marker Control
1.0 Submitter
Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 Telephone: (949) 598-1200 (949) 598-1555 Fax:
Contact Person
Yvette Lloyd Senior Regulatory Affairs Specialist Telephone: (949) 598-1465
Date of Summary Preparation
May 18, 2001
2.0 Device Identification
Lyphochek® Tumor Marker Control Product Trade Name:
Multi-Analyte Controls, (Assayed and unassayed) Common Name:
| Classifications: | Class I |
|---|---|
| Product Code: | 75JJY |
| Regulation Number: | CFR 862.1660 |
Device to Which Substantial Equivalence is Claimed 3.0
Lyphochek® Tumor Marker Control Bio-Rad Laboratories Irvine, California
Docket Number: K992172
4.0 Description of Device
Lyphochek® Tumor Marker Control is prepared from human serum with added constituents of human origin and pure chemicals.
The control is provided in lyophilized form for increased stability
06_510(k) Itm_580 05/01
1
Statement of Intended Use 5.0
Lyphochek® Tumor Marker Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for analytes listed in this package insert.
Comparison of the new device with the Predicate Device 6.0
The new Lyphochek® Tumor Marker Control claims substantial equivalence to the Lyphochek® Tumor Marker Control currently in commercial distribution (K992172). The new Lyphochek® Tumor Marker Control has improved open-vial stability claims for CA 27-29, and improved reconstituted freeze-thaw stability claims for PSA, Calcitonin, and ACTH.
| Bio Rad | Bio Rad | |
|---|---|---|
| Characteristics | Lyphochek® Tumor Marker Control | Lyphochek® Tumor Marker Control |
| (New Device) | (Predicate Device) | |
| Similarities | ||
| Intended Use | The 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 the package | ||
| insert. | The 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 the package insert. | ||
| Form | Lyophilized | Lyophilized |
| Matrix | Human serum based | Human serum based |
| Storage | ||
| (Unopened) | 2°C to 8°C | |
| until expiration date | 2°C to 8°C | |
| until expiration date | ||
| Differences | ||
| Open | ||
| Vial Claim | All analytes will be stable for 14 | |
| days when stored at 2 - 8°C with | ||
| the following exceptions: Ferritin | ||
| and CA 27-29 will be stable for 6 | ||
| days. ACTH, Free PSA, PSA, and | ||
| Calcitonin should be assayed | ||
| immediately following | ||
| reconstitution. | All analytes will be stable for 14 | |
| days when stored at 2 - 8°C with | ||
| the following exceptions: ACTH, | ||
| Free PSA, PSA, and Calcitonin | ||
| should be assayed immediately | ||
| following reconstitution. | ||
| Reconstituted | ||
| Freeze Vial | ||
| Claim | All analytes will be stable after | |
| reconstituting and freezing for 30 | ||
| days when stored at -10°C to -20 | ||
| °C. | All analytes will be stable for 30 | |
| days after reconstituting and | ||
| freezing when stored at -10°C to - | ||
| 20 °C, with the following | ||
| exceptions: (1) PSA will be stable | ||
| for 20 days and (2) ACTH and |
Table 1. Similarities and Differences between new and predicate device.
06_510(k) ltm 580 05/01
2
| Calcitonin do not have frozen |
|---|
| stability claims. |
| Company of the comments of the first for the commend of the Research and AMER Management of AMERICAN Company of CARRANT Program |
7.0 Summary of Performance Data
Stability studies have been performed to determine the open vial stability and shelf life for the Lyphochek® Tumor Marker Control. Product claims are as follows:
- 7.1 Once the control is reconstituted, all analytes will be stable for 14 days when stored tightly capped at 2 - 8°C, with the following exceptions: Ferritin and CA 27-29 will be stable for 6 days. ACTH, Free PSA, PSA, PSA, and Calcitonin should be assayed immediately following reconstitution. For optimum precision of Ferritin, allow vial to equilibrate for a minimum of 2 hours prior to assay.
- 7.2 After reconstituting and freezing the control, all analytes will be stable for 30 days when stored tightly capped at -10℃ to -20 ℃. Once thawed, do not refreeze the control; discard remaining material.
- 7.3 The control is stable for 3 years and 3 months when stored unopened at 2 - 8°C.
Real time studies will be ongoing to support the shelf life of this product.
All supporting data is retained on file at Bio-Rad Laboratories.
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (USA). The seal features the department's name arranged in a circular pattern around a central emblem. The emblem is a stylized representation of an eagle, with three curved lines forming its body and wings.
JUN 2 6 2001
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Donna Chapman Quality Assurance/Regulatory Affairs Manager Bio-Rad Laboraties, QSD 9500 Jeronimo Road Irvine, CA 92618-2017
510(K) Number: K011579 Re: Trade/Device Name: Lyphochek® Tumor Marker Control Regulation Number: 862.1660 Regulatory Class: I Product Code: JJY Dated: May 18, 2001 Received: May 22, 2001
Dear Ms. Chapman:
We have reviewed your Section 510(k) notification of intent to market the device referenced with have loviewed your betermined the device is substantially equivalent (for the indications for use atoo in the enclosure) to legally marketed predicate devices marketed in interstate commerce sured in and 28, 1976, the enactment date of the Medical Device Amendments, or to devices that provision associated in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Oostions of the Act. The general controls provisions of the Act include requirements for annual profistration, 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2
This letter will allow you to begin marketing your device as described in your 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".
Sincerely yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
K011579 510 (k) Number (if known):_
Device Name: Lyphochek® Tumor Marker Control
Indications for Use:
An assayed quality control serum to monitor the precision of laboratory testing procedures for analytes listed in the package insert.
Signature
(Division Sign-Off) Division of Clinical Laboratory Devices K011579 510(k) Number _
(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