BECKMAN URINE PROTEIN CALIBRATOR (UCAL)

K973928 · Beckman Instruments, Inc. · JIX · Dec 1, 1997 · Clinical Chemistry

Device Facts

• Record ID: K973928
• Device Name: BECKMAN URINE PROTEIN CALIBRATOR (UCAL)
• Applicant: Beckman Instruments, Inc.
• Product Code: JIX · Clinical Chemistry
• Decision Date: Dec 1, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

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.

Device Story

The Beckman Urine Protein Calibrator (UCAL) is a liquid human urine matrix containing added albumin, transferrin, alpha-1-microglobulin, and immunoglobulin G. It is used in clinical laboratory settings to calibrate Beckman Array, Array 360, and IMMAGE Immunochemistry Systems. These systems are automated nephelometric analyzers. The calibrator provides a response value used to adjust pre-programmed calibration curves, allowing the systems to accurately determine analyte concentrations in patient urine specimens. By establishing these reference points, the device ensures the accuracy of quantitative protein measurements, which aids clinicians in diagnosing and monitoring renal or other protein-related conditions.

Clinical Evidence

Bench testing only. The value assignment process for each analyte is correlated to a known standard via the anchor method. Verification processes confirmed that the calibrator yields acceptable assigned values for use on both Array and IMMAGE instrument systems.

Technological Characteristics

Liquid human urine matrix containing albumin, transferrin, alpha-1-microglobulin, and immunoglobulin G. Operates via nephelometry on automated immunochemistry systems (Array, Array 360, IMMAGE).

Indications for Use

Indicated for use as a calibrator in clinical laboratory test systems to establish points of reference for the measurement of microalbumin, urine transferrin, alpha-1-microglobulin, and urine immunoglobulin G in human urine specimens.

Regulatory Classification

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.)

Special Controls

*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.

Predicate Devices

• Beckman Urine Protein Calibrator (K895883)
• Beckman Urine Protein Calibrator (K926272)
• Beckman Urine Protein Calibrator (K933078)
• Beckman Urine Protein Calibrator (K951635)

Submission Summary (Full Text)

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K973928

# 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: [phone] FAX: [phone]

## 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<br>Protein Calibrator | Beckman Urine<br>Protein Calibrator | Beckman<br>Instruments, Inc. | K895883 (MA)<br>K926272 (TRU)<br>K933078 (A1M)<br>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.

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#### 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 [phone].

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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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