(12 days)
K945651/A004
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No
The document describes a quality control serum for laboratory testing and contains no mention of AI or ML technology.
No
Explanation: The device is a quality control serum used to monitor the precision of laboratory testing procedures, not to treat a disease or condition.
No
Explanation: The device is described as an "assayed quality control serum to monitor the precision of laboratory testing procedures" and is used in a laboratory setting. It is not used to diagnose a disease or condition in a patient.
No
The device description clearly states it is a liquid control serum prepared from human serum with added components, 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 - to be used in vitro (outside the body) to assess the performance of diagnostic tests.
- Device Description: It's a "quality control serum" prepared from human serum. Quality control materials are a fundamental component of IVD testing to ensure the accuracy and reliability of results.
- Care Setting: It's intended for use in "laboratory testing procedures," which is the typical environment for IVD use.
The fact that it's a quality control material used to monitor the performance of other diagnostic tests firmly places it within the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Liquichek Immunology 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
Liquichek Immunology Control is prepared from human serum with added serum proteins and stabilizers. The control 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
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
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)
K945651/A004
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
Image /page/0/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 a black rectangle with rounded corners, and the words "BIO-RAD" are written in white, bold letters inside the rectangle. The letters are slightly slanted to the right, and the overall design is simple and modern.
Bio-Rad Laboratories California 92618
K99 2550
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 May 3, 1999
Device (Trade & Common Name) Liquichek Immunology 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 Immunology Control Bio-Rad Laboratories Irvine, California K945651/A004
Statement of Intended Use
Olatement of intended for use as an assayed quality control serum Elquionon inimationy 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 develops, manufactures, and markets a broad range of products and services to the life science research and clinical diagnostics markets. The logo is in a black rounded rectangle with the words "BIO-RAD" in white letters. The letters are bold and sans-serif.
Bio-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017 Telephone: (949) 598-1200
Description of the Device
Description of the Device
Liquichek Immunology Control is prepared from human serum with added serum
ing in the Immunology Control is prepared from for convenience Liquichek Immunology Control is prepared from haman bearn for convenience.
proteins and stabilizers. The control 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 A table is provided below companing the similance between is claimed.
Immunology Control and the devices to which substantial equivalence is claimed.
Immunology Control and t
| | Bio-Rad Liquichek Immunology
Control (New Device) | Bio-Rad Immunology Control
(Substantially Equivalent Device) |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 | Liquid | Liquid |
| Matrix | Human serum based | Human serum based |
| Storage | 2-8°C | 2-8°C |
| Open Vial
Claim | 90 days when thawed and stored
unopened at 2-8°C; 30 days when
opened and stored tightly capped at
2-8°C. | 90 days when thawed and stored
unopened at 2-8°C; 30 days when
opened and stored tightly capped at
2-8℃. |
| Analytes | Same analytes as the substantially
equivalent device; refer to proposed
product insert. | Refer to attached substantially
equivalent device product insert. |
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
DEPARTMENT OF HEALTH & HUMAN SERVICES
AUG 11 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Elizabeth Platt Regulatory Affairs Supervisor Bio-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvinc, California 92618-2017
K992550 Re:
K992530
Trade Name: Liquichek Immunology Control Regulatory Class: I Product Code: JJY Dated: July 29, 1999 Received: July 30, 1999
Dear Ms. Platt:
Deal new reviewed your Section 510(k) notification of intent to market the device referenced.
The have reviewed the device is cubstantially equivalent (for the indications fo We have reviewed your Section 510(k) notification of thient in our of the indications for use
above and we have and well meedsted predicated predicate devices marketed in int above and we have determined the device is substantially equivalent (over the marketed in interstate commerce
s and we no more of the markmant deta of the Medical Devices mar stated in the enclosure) to legally markets in the Medical Device Amendments, or to devices that
prior to May 28, 1976, the enactment date of the Federal Food, Dug, and prior to May 28, 1976, the enatment and on the Federal Food, Drug, and have been reclassified in accordance with the provisions of the reast controls
Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Cosmetic Act (Act). You may, therefore, market the Act include requirements for annual
provisions of the Act. The general controls provisions of the Act include requirents provisions of the Act. The general controls provisions of the Heerines of the Prohibitions against
registration, listing of devices, good manufacturing practice, labeling, a misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III
n report of the success of the states of instite work additional controls. Exist If your device is classified (see abded) into ender class in (opentials . Existing major regulations.
(Premarket Approval), it may be subject to such additions Title 21, Par (Premarket Approval), it may be sibject to such auch as money on the 21, Parts 800 to 895.
affecting your device can be found in the Code of Federal Regulations with the Curr attecting your device can be found in this ossumes compliance with the Current Good
A substantially equivalent determination the Ouclity System Regulation (C A substantially equivalent decemblacion asset forthe Quality System Regulation (QS) for
Manufacturing Practice requirements, as set for the Quality System Regulation (OS) Manufacturing Practice requirements, as set reart 820) and that, through penodic QS
Medical Devices: General regulation (21 CFR Part of a wife such accurations Medical Devices: General regulation (21 OFR Parvensy such assumptions. Failure to
inspections, the Food and Drug Administration (FDA) will ver EDA may watch inspections, the rood and Drug Aummondation (orgulatory action. In addition, PDA may publish comply with the GMT regaration may rodevice in the Federal Register. Please note: this further alliouncements concerning your submission does not affect any obligation you might response to your premarket nothleads of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may Under the Chilical Laboratory Interestion. To determine if it does, you should contact the require a CETA comproxity Sangeres
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 I his letter will allow you to ocgin marketing your device to a legally marketed to notification. The PDA inding of substantial equivalians 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 additionally 809.10 for mi vitto diagnostions on the promotion and advertising of your device, (201) 594-4568. Additionally, for questions of (301) 594-4639. Also, please note the regulation presse contact the Office of Comphalled (21 CFR 807.97). The grand of Science of Small information on your responsibilities under the Act may be obtained from the Division of Small mioritiation on your responsionness and imber (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 Immunology Control
Indications for Use:
Liquichek immunology 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.
(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 | |
| 510(k) Number | K992550 |
| Prescription Use | ✓ | OR Over-The Counter Use | _________________ |
|---|---|---|---|
| ------------------ | ------------------------------------------------------------------- | ------------------------- | ------------------- |