(34 days)
The provided text does not contain any predicate devices with K/DEN numbers. The "Predicate Device(s)" section explicitly states "Not Found".
Not Found
No
The summary describes a liquid urine control for monitoring laboratory instrument precision and accuracy. There is no mention of AI or ML in the intended use, device description, or specific sections for AI/ML information.
No.
This device is an in vitro diagnostic control material used to monitor the precision and accuracy of laboratory instruments, not a device intended for treating or diagnosing medical conditions in patients.
No
Explanation: The device is a control material used to monitor the precision and accuracy of instruments in a clinical laboratory. It is not used to diagnose a medical condition in a patient.
No
The device is described as a "synthetic matrix based assayed liquid urine multi-constituent control," which is a physical substance used for quality control in laboratory instruments. It is not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's a "synthetic matrix based assayed liquid urine multi-constituent control intended to monitor the precision and accuracy of instrument used in the clinical laboratory environment." This describes a product used in vitro (outside the body) to evaluate the performance of diagnostic instruments.
- Device Description: The description confirms it's a "synthetic matrix based assayed liquid urine multi-constituent control," which is a type of material used in IVD testing.
- Anatomical Site: The "Not Applicable (in vitro diagnostic device)" entry further supports its classification as an IVD.
- Intended User / Care Setting: The intended user is the "Clinical laboratory environment," which is where IVD testing is performed.
All these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
MCC™ URICHECK™ from HEMATRONIX, INC. is a synthetic matrix based assayed liquid urine multi-constituent control intended to monitor the precision and accuracy of instruments used in the methods when run as a patient sample and is ready to use. Expected ranges used in the methods when run as a patient sample and is ready and physical properties of MCC™ monitoring or quantitutive "constitutively" "have themistry analysis.
Product codes
JJY
Device Description
Not Found
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
clinical laboratory environment
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)
Not Found
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.
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Image /page/0/Picture/1 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 a stylized image of three overlapping stripes, resembling an abstract representation of an eagle or bird in flight.
AUG 2 0 2001
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. James SaFranko Director of Operations, Manufacturing Hematronix, Inc. 524 Stone Road, Suite A Benicia, CA 94510
Re: 510(k) Number: K012243 Trade/Device Name: MCC™ URICHECK™ Assayed Liquid Urine Multi-constituent
Control
Regulation Number: 862.1660 Regulatory Class: I, reserved Product Code: JJY Dated: July 16, 2001 Received: July 17, 2001
Dear Mr. SaFranko:
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 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, 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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 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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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 1 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer 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 Autman
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
2
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: MCC™ URICHECK™ Assayed Liquid Urine Multi-Constituent Control
Indications For Use:
MCC™ URICHECK™ from HEMATRONIX, INC. is a synthetic matrix based assayed liquid urine MCC™ ORICHLOR' from HEMATHONIX, three in the clinical laboratory environment. MCC™ multi-consitions intended to monitor the precision and accuracy of instrument used in the methods when run as a patient sample and is ready to use. Expected ranges used in the methous when furt as a patient sumplo and is ready and physical properties of MCC™ monitoring or quantitutive "constituently" "have themistry analysis.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kesia Alexander for Jean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)