(19 days)
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No
The summary describes a quality control serum for laboratory testing, with no mention of AI or ML technology in the intended use, device description, or specific sections for AI/ML mentions.
No
The device is a quality control serum used to monitor the precision of laboratory testing procedures, not to treat or diagnose a medical condition.
No
Explanation: The device is described as an "assayed quality control serum to monitor the precision of laboratory testing procedures," indicating it is used for quality control, not for diagnosing patients.
No
The device is a quality control serum, which is a biological product provided in lyophilized form, not a software application.
Based on the provided information, 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 in the package insert." 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 biological materials (human plasma) with added constituents, provided in a form suitable for laboratory use (lyophilized).
- Intended User / Care Setting: It's intended for "laboratory testing procedures," which is the typical setting for IVDs.
- Reference Device(s): The mention of a "Reference Device(s)" with a K number (K971952) and the name "Lyphochek Hypertension Markers Control" strongly suggests that this device is being compared to or is a successor to a previously cleared IVD.
The definition of an IVD generally includes reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. While this specific device is a quality control and not directly used for diagnosis, it is an essential component of the overall IVD testing process, ensuring the accuracy and reliability of diagnostic results. Quality controls are considered IVDs by regulatory bodies.
N/A
Intended Use / Indications for Use
Lyphochek Hypertension Markers 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.
Lyphochek Hypertension Markers 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
JJY
Device Description
Lyphochek Hypertension Markers Control is prepared from defibrinated human plasma with added constituents of human origin and pure chemicals. The control is provided in lyophilized form for increased stability. This product contains 0.1% sodium azide as a preservative.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Renin Control Ciba Corning Diagnostics
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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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Image /page/0/Picture/1 description: The image shows the logo for Bio-Rad. The logo is white text on a black, rounded rectangle. The text is in a bold, sans-serif font.
Bio-Rad
Laboratories
OS F Miraloma Avenu heim. CA 92806 lephone (714) 630-640 I Free (800) 854-6737
JUN 16 1997
510(k) Summary
Submitter Bio-Rad Laboratories, ECS Division 3726 E. Miraloma Avenue Anaheim. CA 92806 (714)630-6400 Fax (714)666-1383
Contact Person Elizabeth Platt
Date of Summary Preparation May 27, 1997
Device (Trade & Common Name) Lyphochek Hypertension Markers Control
Classification Name Class 1, 75JJY CFR 862.1660: Quality Control Material (Assayed and Unassayed)
Devices to Which Substantial Equivalence is Claimed Renin Control Ciba Corning Diagnostics
Statement of Intended Use
Medfield, MA
Lyphochek Hypertension Markers 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.
1
Image /page/1/Picture/0 description: The image shows the logo for Bio-Rad. The logo is white text on a black rounded rectangle. The text is in all caps and bolded.
Bio-Rad
Laboratories
ECS Division 3726 E. Miraloma Avenue Anaheim. CA 92806 Telephone (714) 630-6400 Toll Free (800) 854-6737
Description of the Device
Lyphochek Hypertension Markers Control is prepared from defibrinated human plasma with added constituents of human origin and pure chemicals. The control is provided in lyophilized form for increased stability.
This product contains 0.1% sodium azide as a preservative.
Statement of How Technological Characteristics Compare to Substantial Equivalence Device
A table is provided below comparing the similarities between the Bio-Rad Lyphochek Hypertension Markers Control and the device to which substantial equivalence is claimed.
| | Bio-Rad Lyphochek Hypertension
Markers Control | Ciba Corning Diagnostics
Renin Control |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use | An assayed quality control serum
to monitor the precision of
laboratory testing procedures for
the analytes listed in the
package insert. | To monitor the precision and the
accuracy of clinical chemistry test
procedures which analyze renal
and adrenal function. |
| Levels | Three | Two |
| Form | lyophilized | lyophilized |
| Open
Vial
Claim | 21 Days at 2-8°C with the
exception of ACTH which should
be assayed immediately after
reconstitution | 8 hours at 2-8°C
-- |
| Matrix | defibrinated human plasma | human plasma |
| Storage | 2-8°C | 2-8°C |
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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 caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The caduceus is rendered in black, and the text is also in black. The logo is simple and recognizable, representing the department's mission to protect the health of all Americans.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 1 6 1997
Elizabeth Platt Staff Regulatory Affairs Representative Bio-Rad Laboratories 3726 E. Miraloma Avenue Anaheim, California 92806
Re: K971952 Lyphochek Hypertension Markers Control Requlatory Class: I Product Code: JJY Dated: May 27, 1997 Received: May 28, 1997
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, Druq, 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 aqainst 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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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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 requlation (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 requlation 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
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Page 1 of 1
971952 510(k) Number: Device Name: Lyphochek Hypertension Markers Control 参 Indications for Use:
Lyphochek Hypertension Markers 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.
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number
(PLEASE DO NOT WRITE BELOW THE LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(Concurrence of CDRH, Office of Device Evaluation)
Prescription Use
(1
Over-The Counter Use _ OR
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