(32 days)
K-880496
K-880496
No
The document describes a quality control material for urine chemistry tests and does not mention any AI or ML components or functionalities.
No
Explanation: This device is a quality control material intended to monitor the performance of urine chemistry test procedures, not to treat or diagnose any medical condition.
No
This device is a control material used to monitor the performance of urine chemistry test procedures, not to diagnose a condition directly.
No
The device is a physical, lyophilized urine-based quality control material, not a software application.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's "intended to monitor the performance of urine chemistry test procedures." This means it's used in vitro (outside the body) to assess the accuracy and reliability of tests performed on a biological sample (urine).
- Device Description: The description reinforces this by stating it's "designed to monitor the performance of urine chemistry test procedures."
- Nature of the Device: It's a "quality control material." Quality control materials are a fundamental component of IVD testing, used to ensure the test system is functioning correctly.
- Predicate Device: The mention of a predicate device (K-880496 LYPHOCHEK® QUANTITATIVE URINE CONTROL) which is also a urine control, further confirms its classification as an IVD.
Therefore, based on the provided information, this device clearly fits the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Urine Chemistry Control, Level 1, is a lyophilized human urine based assayed quality control material intended to monitor the performance of urine chemistry test procedures that analyze inorganics, metals, drugs, endocrine hormones and metabolites.
Product codes
JJW
Device Description
Urine Chemistry Control, Level 1, is designed to monitor the performance of urine chemistry test procedures that analyze inorganics, metals, drugs, endocrine hormones and metabolites. Human and porcine components are added to a human urine based matrix to provide a control that closely mimics human urine. The product contains no preservatives. Urine Chemistry Control, Level 1 will be offered in 10.0 mL and 25.0 mL fill vials.
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
Not Found
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)
K-880496
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
Product Performance and Substantial Equivalency
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807 92.
The assigned 510(k) number is: K 9936 7(k)
Submitter: SeraCare Technology, Inc. DBA Consolidated Technologies 2170 Woodward Street Austin, TX 78744-1832 Phone: (512) 445-5100 (512) 445-5515 Fax:
Contact: Rusty Sewell Preparation date:
July 28, 1999
Product name (trade & common):
Proprietary: Urine Chemistry Control, Level 1 Common: Not Applicable
Classification name:
Class 1 . Product code: JJW 21 CFR 862:1660 : Urinalysis Controls (Assayed and Unassayed)
Predicate device:
LYPHOCHEK® QUANTITATIVE URINE CONTROL BIO-RAD Laboratories K-880496
Device description:
Urine Chemistry Control, Level 1, is designed to monitor the performance of urine chemistry test procedures that analyze inorganics, metals, drugs, endocrine hormones and metabolites. Human and porcine components are added to a human urine based matrix to provide a control that closely mimics human urine. The product contains no preservatives. Urine Chemistry Control, Level 1 will be offered in 10.0 mL and 25.0 mL fill vials.
Intended use:
Urine Chemistry Control, Level 1, is a lyophilized human urine based assayed quality control material intended to monitor the performance of urine chemistry test procedures that analyze inorganics, metals, drugs, endocrine hormones and metabolites.
- Vial labels see Attachments I and II Labeling: Secondary Container label, see Attachments III and IV Package Insert, see Attachment V
1
Product Performance and Substantial Equivalency
510(k) Summary (continued)
Comparative analysis:
The table below provides a summary of the technological characteristics between Urine Chemistry Control and the predicate device.
| Device
Characteristic | Urine Chemistry Control,
Level 1 | Lyphochek® Quantitative Urine
Control, Normal (1) |
|--------------------------|----------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| Intended use | Assayed quality control urine for
monitoring performance of urine
chemistry test procedures. | Assayed quality control urine for
monitoring precision of laboratory
testing procedures. |
| Matrix | Human Urine | Human Urine |
| Form | Lyophilized | Lyophilized |
| Analytes | 48 analytes of clinical significance
that may be found in urine. | 51 analytes |
| Storage | 2-8°C | 2-8°C |
| Stability | Until expiration date noted on vial
label. | Until expiration date noted on vial
label |
Conclusions:
The information provided in the pre-market notification demonstrates that Urine Chemistry Control, Level 1, is substantially equivalent to the predicate device, for which there is FDA clearance. This equivalence was demonstrated through comparison of intended uses and physical properties to a commercially available device. The information supplied in the pre-market notification provides reasonable assurance that Urine Chemistry Control, Level 1, is safe and effective for the stated intended use.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle with three lines representing its wings.
SEP 3 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Rusty Sewell Product Development Engineer SeraCare Technology, Inc. DBA, Consolidated Technologies 2170 Woodward Street Austin, Texas 78744-1832
Re: K992576
Trade Name: Urine Chemistry Control, Level 1 Regulatory Class: I Product Code: JJW Dated: July 28, 1999 Received: August 2, 1999
Dear Mr. Sewell:
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 Regulations, 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 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
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
4
INDICATIONS FOR USE STATEMENT
510(k) number (if known): K 992576
Device name: Urine Chemistry Control, Level 1
Indications for use:
Urine Chemistry Control, Level 1, is a lyophilized human urine based assayed quality control material intended to monitor the performance of urine chemistry test procedures that analyze inorganics, metals, drugs, endocrine hormones and metabolites.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Artur E. Maksimi
(Division Sign-Off)
Division of Clinical Laboratory Devices K992576
510(k) Number
Luesciphoi ✓