(19 days)
No
The summary describes a quality control serum for laboratory testing, with no mention of AI or ML in its intended use, device description, or performance studies.
No
This device is a quality control serum used to monitor the precision of laboratory testing procedures, not to directly treat a patient's disease or condition.
No
Explanation: The device is a quality control serum used to monitor the precision of laboratory testing procedures, not to diagnose a condition in a patient.
No
The device is a quality control serum, which is a physical substance used in laboratory testing, not a software application.
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 examine specimens derived from the human body to provide information for diagnostic purposes.
- Device Description: The description mentions it's prepared from "human serum" and is used in "laboratory testing procedures." This further supports its use in a laboratory setting for analyzing human samples.
- Predicate Device: The mention of a predicate device (K984225 Bio-Rad Liquichek Ethanol/Ammonia Control) which is also a quality control material for laboratory testing, strongly suggests that this device falls under the same regulatory category, which is IVD.
While the document doesn't explicitly state "In Vitro Diagnostic," the intended use, device description, and the nature of the predicate device all point to it being an IVD. It's a quality control material used in vitro (outside the body) to assess the performance of diagnostic tests.
N/A
Intended Use / Indications for Use
Liquichek Serum Volatiles 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 Serum Volatiles Control is prepared from human serum with added constituents of human origin, pure chemicals, and stabilizers. This product is provided in liquid form for convenience. This product contains 0.1% sodium azide as a preservative.
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
laboratory
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
DEC 14 1998
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 a bold, sans-serif font. The plus sign is slightly raised above the baseline of the other letters. The logo is set against a black background.
Bio-Rad Laboratories
leronimo Roan vine. California 92618-2017 lenhone: (949) 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 November 20, 1998
Device (Trade & Common Name) Liquichek Serum Volatiles Control
Classification Name CFR 862.1660: Quality Control Materials (Assayed and Unassayed)
Devices to Which Substantial Equivalence is Claimed Bio-Rad Liquichek Ethanol/Ammonia Control Bio-Rad Laboratories Irvine, California
Statement of Intended Use
Liquichek Serum Volatiles 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 white text on a black background. The text is bold and sans-serif.
Bio-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017 Telephone: (949) 598-1200
Description of the Device
Liquichek Serum Volatiles Control is prepared from human serum with added constituents of human origin, pure chemicals, and stabilizers. 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 Serum Volatiles Control and the devices to which substantial equivalence is claimed.
| | Bio-Rad Liquichek
Ethanol/Ammonia Control | Bio-Rad Liquichek
Serum Volatiles 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 | Liquid | Liquid |
| Matrix | Bovine Serum | Human Serum |
| Storage | 2-8°C | 2-8°C |
| Analytes | Ammonia, Ethanol | Acetone, Ethanol, Ethylene
Glycol, Isopropanol,
Methanol |
| Open Vial
Claim | 20 Days at 2-8°C | 10 Days at 2-8°C |
2
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 seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized human profiles facing to the right.
DEC 1 4 1998
Ms. Elizabeth Platt Requlatory Affairs Supervisor Bio-Rad Laboratories Diaqnostics Group 9500 Jeronimo Road Irvine, California 92618-2017
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
K984225 Re: Liquichek Serum Volatiles Control Trade Name: Requlatory Class: I Product Code: JJY Dated: November 24, 1998 November 25, 1998 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 regulations 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 Requlation (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 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
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 regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other qeneral 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 Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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Page 1 of 1
510(k) Number: _______________________________________________________________________________________________________________________________________________________________ Device Name: Liquichek Serum Volatiles Control
Indications for Use:
Liquichek Serum Volatiles 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)
| Prescription Use | |
|---|---|
| OR Over-The Counter Use |
(Division Sign-Off)
31 Division of Clinical Laboratory Devices
510(k) Number