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 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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Beckman Urine Protein Calibrator (UCAL).

Based on the provided K973928 document, the submission is for a Calibrator for in vitro diagnostic use. The purpose of a calibrator is to establish reference points for measuring substances. Therefore, the "device performance" in this context refers to the calibrator's ability to consistently and accurately provide values for calibration.

Critical Note: This document does not contain detailed information about specific numerical acceptance criteria or a formal clinical/analytical study designed to prove the device meets such criteria in the way a medical device efficacy study typically would. This K973928 is a 510(k) premarket notification for a calibrator, which often relies on demonstrating substantial equivalence to a predicate device rather than presenting extensive de novo performance studies with detailed statistical metrics, particularly for performance metrics like sensitivity, specificity, accuracy, etc., which are common for diagnostic tests.

Instead, the document emphasizes the value assignment and verification process for the calibrator, ensuring it performs comparably to the predicate device and across different instrumentation.

1. Table of Acceptance Criteria and Reported Device Performance

As detailed acceptance criteria with quantitative targets (e.g., "accuracy > 95%") are not explicitly stated in this 510(k) summary, I will infer what "acceptance" means in the context of a calibrator and the information provided.

Acceptance Criteria (Inferred from document)	Reported Device Performance
A. Substantial Equivalence to Predicate Device	The device is "identical to the current product" except for an additional instrument platform. "Summary of Performance Data" states that safety and effectiveness support "substantial equivalence to chemistry test systems already in commercial distribution." This implies the performance is accepted if it matches the predicate.
B. Consistent Value Assignment	"The value assignment process for each analyte is correlated to a known standard via the anchor method."
C. Acceptable Calibrator Assigned Values for Calibration Systems	"The Beckman Urine Protein Calibrator value assignment and verification processes yield acceptable calibrator assigned values for calibration on the Array® and IMMAGE™ Systems." (No specific numerical range or threshold is provided, but the process is deemed "acceptable.")
D. Functional on Specified Instrument Platforms	Designed for use on Array®, Array® 360, and IMMAGE™ Systems. The document explicitly includes the IMMAGE™ system as a new platform for this calibrator, suggesting performance on this system was evaluated.
E. Retention of Intended Use	The intended use clearly specifies its role as a calibrator for MA, TRU, A1M, and IGU reagents on the specified systems. The submission confirms this intended use.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated in the document. For a calibrator, a "test set" might refer to multiple lots of the calibrator being manufactured and tested, or repetitions of measurements on control materials.
Data Provenance: Not specified (e.g., country of origin). The study appears to be an internal performance evaluation by Beckman Instruments, Inc.
Retrospective or Prospective: Not specified, but likely part of a prospective manufacturing and validation process for the calibrator lots and its use on the new IMMAGE™ system.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This type of information (number and qualifications of experts) is typically associated with studies involving human observation, interpretation (like radiology or pathology), or complex diagnostic tasks. For a calibrator, the "ground truth" is generally established through a traceability chain to reference materials and established analytical methods.

Number of Experts: Not applicable/not stated.
Qualifications of Experts: Not applicable/not stated. The ground truth likely comes from certified reference materials and the expertise of analytical chemists/engineers within Beckman.

4. Adjudication Method for the Test Set

Not applicable/not stated. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human readers or experts when establishing a consensus ground truth, which is not relevant for calibrator value assignment.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study focuses on how human readers perform with or without AI assistance, which is irrelevant for a calibrator.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done

Yes, in spirit, a standalone evaluation was done. The "device" here is the calibrator itself, and its performance (value assignment and verification) is assessed independently of a human interpreter. The calibrator's assigned values are determined and then verified by instruments/analytical methods. While humans are involved in the process of value assignment and verification, the "performance" of the calibrator in setting reference points is an inherent property of the material itself and how it interacts with the instrument, which is then analytically confirmed.

7. The Type of Ground Truth Used

Established Reference Standards/Traceability: The document states, "The value assignment process for each analyte is correlated to a known standard via the anchor method." This indicates that the ground truth for the calibrator's assigned values is based on traceability to known analytical standards. For diagnostic calibrators, this typically means:
- Certified Reference Materials (CRMs): Materials with precisely known concentrations of analytes, usually traceable to international standards (e.g., NIST).
- Validated Analytical Methods: Highly accurate and precise laboratory methods used to determine the exact concentration of analytes in the calibrator material, linked to primary reference measurement procedures.

8. The Sample Size for the Training Set

Not applicable/not stated. Calibrators, in this context, are not "trained" in the way an AI algorithm or machine learning model would be. Their values are assigned and verified through analytical processes, not through learning from a "training set" of data.

9. How the Ground Truth for the Training Set was Established

Not applicable/not stated. As there is no "training set" in the machine learning sense for a calibrator, this question does not apply. The ground truth for the calibrator's assigned values is established through correlation to known standards via the anchor method, as explained in point 7.

Summary

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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: (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 UrineProtein Calibrator	Beckman UrineProtein Calibrator	BeckmanInstruments, Inc.	K895883 (MA)K926272 (TRU)K933078 (A1M)K951635 (IGU)

5.0 Description:

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6.0 Intended Use:

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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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 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

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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)

Over-the-Counter Use
Optional Format 1-2-96

(Division Sign-Off)
Division or Cilnical Laboratory Devices
510(k) Number. K973978

Regulation Number and Section

§ 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.