(28 days)
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No
The document describes a quality control material for laboratory testing and contains no mention of AI or ML technologies.
No.
The device is a quality control material used to monitor the precision of laboratory testing procedures, not to treat a disease or condition.
No
The device is a quality control product 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 "human based control with added constituents of human origin and pure chemicals" and is provided in "liquid form," indicating it is a physical substance, not software.
Based on the provided information, the 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 taken from the human body (in this case, spinal fluid) in a laboratory setting to provide information about a person's health.
- Device Description: The description mentions it's a "human based control" and is used in "laboratory testing procedures." This further supports its use in an in vitro setting.
- Predicate Device: The mention of a predicate device with a K number (K932076) and the name "Liquichek Spinal Fluid Control" strongly indicates that this device is regulated as an IVD by the FDA. K numbers are associated with 510(k) submissions, which are required for many medical devices, including IVDs.
While the document doesn't explicitly use the term "IVD," the intended use, device description, and the presence of a predicate device with a K number are all clear indicators that this product falls under the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Liquichek Spinal Fluid 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
JJY
Device Description
Liquichek Spinal Fluid Control is a human based control with added constituents of human origin and pure chemicals. This product is provided in liquid form for convenience. 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
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Key Metrics
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Predicate Device(s)
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.
0
4-7-99
Image /page/0/Picture/1 description: The image shows the text "K990888". The text is written in a handwritten style. The numbers are all clear and legible.
Image /page/0/Picture/2 description: The image shows the logo for BIO-RAD. The logo is white text on a black rounded rectangle. The text is in all capital letters and has a bold font.
tories
A Jeronimo Roar e California 9261 elephone: (949) 598-1.
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 March 8, 1999
Device (Trade & Common Name) Liquichek Spinal Fluid Control
Classification Name Class 1, 75JJY CFR 862.1660: Multi-Analyte Control, All Kinds (Assayed and Unassayed)
Devices to Which Substantial Equivalence is Claimed Liquichek Spinal Fluid Control Bio-Rad Laboratories Irvine, California K932076
Statement of Intended Use
Liquichek Spinal Fluid 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. The logo is white text on a black rounded rectangle. The text is in all capital letters and is bolded.
Bio-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017 Telephone: (949) 598-1200
Description of the Device
Liquichek Spinal Fluid Control is a human based control with added constituents of human origin and pure chemicals. This product is provided in liquid form for convenience.
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 Liquichek Spinal Fluid Control and the devices to which substantial equivalence is claimed.
| | Bio-Rad Liquichek Spinal Fluid
Control (New Device) | Bio-Rad Liquichek Spinal Fluid
Control (Substantially Equivalent
Device) | |
|-----------------|----------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|
| Intended
Use | An assayed quality control to monitor
the precision of laboratory testing
procedures for the analytes listed in
the package insert. | An assayed quality control to monitor
the precision of laboratory testing
procedures for the analytes listed in
the package insert. | |
| | Form | Liquid | Liquid |
| | Matrix | Human based control. | Human based control. |
| | Storage | 2-8°C | 2-8°C |
| | Open Vial
Claim | 30 days when stored tightly capped
at 2-8°C. | 30 days when stored tightly capped
at 2-8°C. |
| Analytes | Albumin, Chloride, Glucose,
Immunoglobulin A, Immunoglobulin
G, Immunoglobulin M, Lactate, Total
Protein, Sodium plus LDH. | Albumin, Chloride, Glucose,
Immunoglobulin A, Immunoglobulin
G, Immunoglobulin M, Lactate, Total
Protein, Sodium. | |
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three intertwined strands representing the department's mission to protect the health of all Americans and provide essential human services.
APH 7 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Elizabeth Platt Staff Requlatory Affairs Representative BIO-RAD LABORATORIES 9500 Jeronimo Road Irvine, CA 92618-2017
Re: K990888 Trade Name: Liquichek Spinal Fluid Control Regulatory Class: I Product Code: JJY March 8, 1999 Dated: March 10, 1999 Received:
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 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 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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. this response to your premarket notification Please note: 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
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Page 1 of 1
510(k) Number: Device Name: Liquichek Spinal Fluid Control
Indications for Use:
Liquichek Spinal Fluid 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.
(PLEASE DO NOT WRITE BELOW THE LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(Concurrence of CDRH, Office of Device Evaluation)
| (Division Sign-Off) | |
|---|---|
| Division of Clinical Laboratory Devices | K990888 |
| 510(k) Number |
| Prescription Use | ✓ |
|---|---|
| ------------------ | ---------------------------------------------------------------- |
OR Over-The Counter Use