(47 days)
Not Found
No
The description focuses on a calibrator for laboratory tests and does not mention any AI/ML components or functionalities.
No
The device is a calibrator for laboratory reagents, used to adjust pre-programmed calibration curves for determining protein concentration values in test specimens. It is not directly used for treating or diagnosing medical conditions, but rather aids in the accuracy of diagnostic tests.
No
Explanation: This device is a calibrator used to adjust pre-programmed calibration curves for protein concentration measurements. It is not directly used to diagnose a medical condition in a patient; rather, it ensures the accuracy of other diagnostic reagents/systems.
No
The device is a physical calibrator prepared from human urine, not a software program.
Based on the provided information, the device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is used "for the calibration of these reagents" (Beckman microalbumin, urine transferrin, alpha-1-microglobulin, and urine immunoglobulin G reagents). These reagents are used to measure substances in urine, which is a biological specimen.
- Device Description: The device is a "Urine Protein Calibrator" prepared from human urine. It is used to adjust calibration curves for determining concentration values of analytes in "test specimens."
- Function: The device provides a "response value that is utilized for the adjustment of pre-programmed calibration curves from which MA, TRU, A1M, and IGU concentration values are determined for test specimens." This is a core function of a calibrator used in in vitro diagnostic testing.
Calibrators are essential components of many IVD test systems, used to ensure the accuracy and reliability of the measurements performed on patient samples. The description clearly indicates this device serves that purpose within a system designed to analyze urine.
N/A
Intended Use / Indications for Use
UCAL (Urine Protein Calibrator), when used in conjunction with Beckman microalbumin (MA), urine transferrin (TRU), alpha-1-microglobulin (A1M), and unine immunoglobulin G (IGU) reagents, is intended for used on Array®, Array® 360, and IMMAGE™ Systems for the calibration of these reagents.
Product codes (comma separated list FDA assigned to the subject device)
JIX
Device Description
The Beckman Urine Protein Calibrator is prepared from human urine to which albumin, transferrin, alpha-1-microglobulin, and immunoglobulin G have been added. Assay of UCAL provides a response value that is utilized for the adjustment of pre-programmed calibration curves from which MA, TRU, A1M, and IGU concentration values are determined for test specimens.
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)
The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. The value assignment process for each analyte is correlated to a known standard via the anchor method. The Beckman Urine Protein Calibrator value assignment and verification processes yield acceptable calibrator assigned values for calibration on the Array® and IMMAGE™ Systems.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K895883, K926272, K933078, K951635
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is 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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BECKMAN
Summary of Safety & Effectiveness Beckman Urine Protein Calibrator (UCAL)
DEC - 1 1997
1.0 Submitted By:
Annette Hellie Sr. Regulatory Specialist, Product Submissions Beckman Instruments, Inc. 200 S. Kraemer Blvd., W-337 Brea, California 92822-8000 Telephone: (714) 993-8767 FAX: (714) 961-4457
2.0 Date Submitted:
October 14, 1997
3.0 Device Name(s):
- Proprietary Names 3.1
Beckman Urine Protein Calibrator (UCAL)
Classification Name 3.2
Calibrator (21 CFR § 862.1150)
Predicate Device(s): 4.0
| Device | Predicate | Manufacturer | Docket Number |
|---|---|---|---|
| Beckman Urine | |||
| Protein Calibrator | Beckman Urine | ||
| Protein Calibrator | Beckman | ||
| Instruments, Inc. | K895883 (MA) | ||
| K926272 (TRU) | |||
| K933078 (A1M) | |||
| K951635 (IGU) |
5.0 Description:
The Beckman Urine Protein Calibrator is prepared from human urine to which albumin, transferrin, alpha-1-microglobulin, and immunoglobulin G have been added. Assay of UCAL provides a response value that is utilized for the adjustment of pre-programmed calibration curves from which MA, TRU, A1M, and IGU concentration values are determined for test specimens.
1
6.0 Intended Use:
UCAL (Urine Protein Calibrator), when used in conjunction with Beckman microalbumin (MA), urine transferrin (TRU), alpha-1-microglobulin (A1M), and unine immunoglobulin G (IGU) reagents, is intended for used on Array®, Array® 360, and IMMAGE™ Systems for the calibration of these reagents.
7.0 Comparison to Predicate(s):
The Beckman Urine Protein Calibrator is a liquid human unne matrix identical to the current product. The only difference is the additional instrument platform on which it will be used. The existing Beckman UCAL is used with Beckman's Array® and Array® 360 Immunochemistry Systems. These systems are fully automated, specific protein analyzers, that measure by nephelometry. The new instrument platform, the IMMAGE™ Immunochemistry System, is also a fully automated, specific protein analyzer that measures by nephelometry.
8.0 Summary of Performance Data:
The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. The value assignment process for each analyte is correlated to a known standard via the anchor method. The Beckman Urine Protein Calibrator value assignment and verification processes yield acceptable calibrator assigned values for calibration on the Array® and IMMAGE™ Systems.
This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing requlation 21 CFR 807.92.
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Image /page/2/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three faces in profile, stacked on top of each other.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC - 1 1997
Annette Hellie . Senior Regulatory Specialist Beckman Instruments, Inc. 200 S. Kraemer Boulevard, W-337 P.O. Box 8000 Brea, California 92822-8000
K973928 Re : Urine Protein Calibrator (UCAL) Requlatory Class: II Product Code: JIX Dated: October 14, 1997 Received: October 15, 1997
Dear Ms. Hellie:
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 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, Druq, 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 aqainst 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 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 In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. 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 requlations.
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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 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 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/dsmamain.html".
Sincerely yours,
Steven Gutman
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
page of
510(k) Number (if known):
Device Name: Beckman Urine Protein Calibrator
Indications for Use:
UCAL (Urine Protein Calibrator), when used in conjunction with Beckman (JCAL (Unne 1 (MA), urine transferrin (TRU), alpha-1-microglobulin (A1M), and urine microalbumin (in ), anno a arrerents (intended for used on Array®, Array® 360, and minunogie built of the calibration of these reagents.
21 CFR 862.1150 Calibrator
(a) Identification. A calibrator if a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens.
(b) Classification. Class II
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
-Prescription Use
(per 21 CFR 801.109)
OR
Over-the-Counter Use
Optional Format 1-2-96
(Division Sign-Off)
Division or Cilnical Laboratory Devices
510(k) Number. K973978