(13 days)
Not Found
No
The document describes a quality control serum for laboratory testing and makes no mention of AI or ML technology.
No
The device is described as a quality control serum used to monitor the precision of laboratory testing procedures, not to treat or diagnose patients.
No
The device is described as an "assayed quality control serum to monitor the precision of laboratory testing procedures," not to diagnose diseases or conditions in patients.
No
The device description explicitly states it is prepared from human serum and provided in lyophilized form, indicating it 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 is a classic function of an IVD, which is used in vitro (outside the body) to provide information about a patient's health status or to monitor the performance of diagnostic tests.
- Device Description: The description mentions it's prepared from human serum and used in "laboratory testing procedures." This further supports its use in a laboratory setting for diagnostic purposes.
- Predicate Device: The mention of a predicate device with a K number (K891475) and the same name ("Lyphochek Immunoassay Plus Control") strongly indicates that this device has gone through the regulatory process for IVDs, which involves demonstrating substantial equivalence to a previously cleared device.
Therefore, the Lyphochek Immunoassay Plus Control fits the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Lyphochek Immunoassay 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
Lyphochek Immunoassay Plus Control is prepared from human serum, with added constituents of human origin, pure chemicals and therapeutic drugs. 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
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)
Not Found
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
Image /page/0/Picture/1 description: The image shows the logo for BIO-RAD. Below the logo, the date MAY 12 1998 is printed. The logo is in bold, black letters, and the date is in a smaller, less bold font. The image is black and white.
Bio-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017 Telephone: (714) 598-1200
510(k) Summary
Submitter Bio-Rad Laboratories 9500 Jeronimo Road Irvine. CA (949)598-1285 Fax (949)598-1555
Contact Person Elizabeth Platt
Date of Summary Preparation April 28, 1998
Device (Trade & Common Name) Lyphochek Immunoassay Plus Control
Classification Name CFR 862.1660: Quality Control Material (Assayed and Unassayed)
Devices to Which Substantial Equivalence is Claimed Lyphochek Immunoassay Plus Control Bio-Rad Laboratories, Irvine, CA K891475
Statement of Intended Use
Lyphochek Immunoassay 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.
1
Image /page/1/Picture/0 description: The image shows the logo for Bio-Rad. The logo is in a rounded rectangle shape. The text "BIO+RAD" is in white, and the background is black.
Bio-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017 Telephone: (714) 598-1200
Description of the Device
Lyphochek Immunoassay Plus Control is prepared from human serum, with added constituents of human origin, pure chemicals and therapeutic drugs. The control is provided in lyophilized form for increased stability.
Statement of How Technological Characteristics Compare to Substantial Equivalence Device
A table is provided below comparing the similarities between the Bio-Rad Lyphochek Immunoassay Plus Control and the device to which substantial equivalence is claimed.
| | Bio-Rad Lyphochek
Immunoassay Plus Control | Bio-Rad Lyphochek
Immunoassay Plus Control
(new submission) |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | An assayed quality control
serum to monitor the
precision of laboratory
testing procedures for the
analytes listed in the
package insert. | 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 | Human Serum |
| Storage | 2-8°C | 2-8°C |
| Reconstituted
Stability
Claim | 7 days at 2-8°C with the
following exceptions: (1) C-
Peptide, Folate and PSA
are stable for 3 days after
reconstitution, (2) ACTH,
Calcitonin and Gastrin
should be assayed
immediately after
reconstitution. | 7 days at 2-8°C with the
following exceptions: (1) C-
Peptide, Folate and PSA are
stable for 3 days after
reconstitution, (2) ACTH,
Calcitonin and Gastrin
should be assayed
immediately after
reconstitution. |
| Differences | Current product does not
have claims for the
following: Total Estrogens,
Flecainide, IgA, IgG, IgM,
Iron, TIBC, Netilmicin,
SHBG. | Product has added claims
for the following: Total
Estrogens, Flecainide, IgA,
IgG, IgM, Iron, TIBC,
Netilmicin, SHBG. |
2
Image /page/2/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 lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 1 2 1998
Elizabeth Platt . Acting Requlatory Affairs/Quality Assurance Bio Rad Laboratories 9500 Jeronimo Road Irvine, California 92618-2017
K981532 Re : Lyphochek Immunoassay Plus Control Requlatory Class: I Product Code: JJY Dated: April 28, 1998 Received: April 29, 1998
Dear Ms. Platt:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual reqistration, 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 Requlations, Title 21, Parts 800 to 895. ਰ 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 In addition, FDA may publish further announcements action. 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 requlations.
3
Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
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" (21 CFR 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/dsmamain.html".
Sincerely yours,
Steven Litman
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
4
510(k) Number: _ Device Name: Lyphochek Immunoassay Plus Control
Indications for Use:
Lyphochek Immunoassay 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 this package insert.
(PLEASE DO NOT WRITE BELOW THE LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| (Concurrence of CDRH, Office of Device Evaluation) | ||
|---|---|---|
| Prescription Use | OR Over-The Counter Use |
Veronica J. Caluin for A Montgomery
(Division Sign-Off)
Division of Clinical Laboratory Devices
| Number | K981532 |
|---|---|
| -------- | --------- |
ﻟﻠﺘﻨﺎﻗﻀﺔ ﺍﻟﻤﺘﻮﻗﻌﺔ ﺍﻟﻤﺘﻮﻗﻌﺔ ﺍﻟﻤﺘﻮﻗﻌﺔ ﺍﻟﻤﺘﻮﻗﻌﺔ ﺍﻟﻤﺘﻮﻗﻌﺔ ﺍﻟﻤﺘﻮﻗﻌﺔ ﺍﻟﻤﺘﻮﻗﻌﺔ ﺍﻟﻤﺘﻮﻗﻌﺔ ﺍﻟﻤﺘﻮﻗﻌﺔ ﺍﻟﻤﺘﻮﻗﻌﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﻮﻗﻌﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﻮﻗﻌﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﻮﻗﻌﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﻮﻗﻌﺔ ﺍﻟ