(36 days)
Not Found
No
The summary describes a quality control material for laboratory testing, with no mention of AI/ML or related concepts like image processing, training/test sets, or performance metrics typically associated with AI/ML devices.
No
The device is described as an "assayed quality control" to "monitor the precision of laboratory testing procedures," indicating it's used for quality control in lab tests, not for treating patients.
No
This device is a quality control material used to monitor the precision of laboratory testing procedures, not to diagnose a condition in a patient.
No
The device description clearly states it is a lyophilized control material prepared from human serum, indicating it is a physical substance, not software.
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 to test samples in vitro (outside the body) to provide information about a patient's health or condition.
- Device Description: The description mentions it's prepared from human serum and used in a laboratory setting. This further supports its use in in vitro diagnostic testing.
- Intended User / Care Setting: The intended user is "laboratory testing procedures," which is where IVDs are used.
- Predicate Device: The mention of a predicate device (K981532; Lyphochek Immunoassay Plus Control) which is also a control material used in laboratory testing, strongly suggests this device falls under the same regulatory category as an IVD.
While the document doesn't contain information about image processing, AI, or patient-specific details, the core function and context of the device clearly align with the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Lyphochek Maternal Serum Control is intended for use as an assayed quality control 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)
75JJY
Device Description
Lyphochek Maternal Serum Control is prepared from human serum with added constituents of human origin, pure chemicals and preservatives. 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
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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/0 description: The image shows the date "FEB 2 1999" in a simple, sans-serif font. The letters and numbers are printed in black ink. The month "FEB" is abbreviated and followed by the day "2" and the year "1999".
Image /page/0/Picture/2 description: The image shows the logo for BIO-RAD. The logo is in black and white, with the words "BIO-RAD" in bold, white letters against a black, rounded rectangle. The plus sign in the middle of the word is slightly larger than the other letters.
Laboratories
Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-201 Telephone: (949) 598-1200
510(k) Summary
Submitter Bio-Rad Laboratories, ECS Division 9500 Jeronimo Road Irvine, CA 92618 (949)598-1285 Fax (949)598-1555
Contact Person Elizabeth Platt
Date of Summary Preparation December 22, 1998
Device (Trade & Common Name) Lyphochek Maternal Serum Control
Classification Name Class I, CFR 862.1660: Multi-Analyte Control (Assayed and Unassayed) 75JJY
Devices to Which Substantial Equivalence is Claimed Lyphochek Immunoassay Plus Control Bio-Rad Laboratories, Irvine, California K981532
Statement of Intended Use
Lyphochek Maternal Serum Control is intended for use as an assayed quality control 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 Laboratories, a company that manufactures and distributes products for the life science research and clinical diagnostics markets. The logo is in black and white, with the words "BIO-RAD" in bold, sans-serif letters. The logo is simple and recognizable, and it is used on a variety of Bio-Rad products and marketing materials. The logo is enclosed in a black rounded rectangle.
Bio-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017 Telephone: (949) 598-1200
Description of the Device
Lyphochek Maternal Serum Control is prepared from human serum with added constituents of human origin, pure chemicals and preservatives. 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 Maternal Serum Control and the device to which substantial equivalence is claimed.
| | Bio-Rad Lyphochek Maternal
Serum Control | Bio-Rad Lyphochek Immunoassay
Plus Control |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 |
| Open
Vial
Claim | 10 days when stored tightly
capped at 2-8°C. | 7 days when stored tightly capped
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. |
| Matrix | Human serum | Human serum |
| Storage | 2-8°C | 2-8°C |
| Analytes | AFP (Alpha-Fetoprotein)
Estriol, Free
HCG-Beta Subunit | AFP (Alpha-Fetoprotein
Estriol, Free
HCG-Beta Subunit
Plus other analytes. |
2
Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in bold, uppercase letters. The text is arranged on a single line and appears to be a header or title. The font is a serif typeface, and the overall impression is one of official documentation or signage.
Public Health Service
2 1999 FEB
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Elizabeth Platt Regulatory Affairs Supervisor Bio-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017
K984594 Re:
Trade Name: Lyphochek Maternal Serum Control Regulatory Class: I Product Code: JJY Dated: December 23, 1998 Received: December 28, 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 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). 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 (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 (OS) 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
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/dsma/dsmamain.html".
Sincerely yours,
Steven Sutman
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
Page 1 of 1
510(k) Number: K984594
Device Name: Lyphochek Maternal Serum Control
Indications for Use:
11
Lyphochek Maternal Serum Control is intended for use as an assayed quality control Lyphochek matermal Ocrain Somethor testing procedures for the analytes listed in the package insert.
Cooper
Sign-Off)
of Clinical Lan
510(k) Number
(Division Sign-Off)
Division of Clinical Laboratory Levices
K984594
(PLEASE DO NOT WRITE BELOW THE LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(Concurrence of CDRH, Office of Device Evaluation)
Prescription Use
Over-The Counter Use __ OR