PRECISET SERUM PROTEINS CALIBRATOR by BOEHRINGER MANNHEIM CORP.

The Preciset® Serum Proteins consists of multi-level calibrators based on human serum. The concentrations of the components have been adjusted to ensure optimal calibration of the following immunoturbidimetric assays: Tina-quant® IgA, Tina-quant® IgG, Tina-quant® IgM, Tina-quant ® C3, and Tina-quant ® C4.

AI/ML Overview

The provided 510(k) summary for the "Preciset® Serum Proteins" calibrator focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of its performance against specific acceptance criteria. This type of submission, common for calibrators and certain other IVDs, often relies on comparing the new device's formulation and intended use to an already cleared predicate.

Therefore, many of the requested details about acceptance criteria, clinical studies, and ground truth establishment are not applicable to this 510(k) submission.

Here's a breakdown of the available information in relation to your request:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated as formal performance acceptance criteria (e.g., accuracy, precision targets). The core "acceptance criteria" for a calibrator in this context is its ability to accurately calibrate the specified immunoturbidimetric assays. This is implied by its composition and comparison to the predicate.
Reported Device Performance: Instead of performance metrics, the document provides the representative constituent levels for each analyte (IgG, IgA, IgM, C3, C4) at different "levels" (1 through 5, or 4 for C3 and C4). These levels are what the calibrator is designed to provide for calibration, not a measure of its performance against a gold standard. The fact that the device was cleared implies that these levels were deemed appropriate for its intended use.

Constituent	Level 1 (mg/mL)	Level 2 (mg/mL)	Level 3 (mg/mL)	Level 4 (mg/mL)	Level 5 (mg/mL)
IgG	215	454	982	1859	3755
IgA	56	108	236	470	941
IgM	46	88	181	361	724
C3	40	74	159	330	NA
C4	6.5	12.8	27.5	56.0	110.6

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

N/A. This document does not describe a clinical performance study using a test set of patient samples. The device is a calibrator, and its evaluation typically involves analytical studies (e.g., accuracy of manufactured concentrations, stability) rather than clinical studies on patient samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

N/A. No test set requiring expert ground truth is described. The "ground truth" for the calibrator's constituent levels would be established through accredited reference materials and methods, as indicated by the "Reference Material: RPPHS" in the table.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

N/A. No test set or adjudication method is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

N/A. This device is a chemical calibrator, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

N/A. This is not an algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the calibrator's constituent levels is based on Reference Material (RPPHS). This indicates that the concentrations of the analytes (IgG, IgA, IgM, C3, C4) in the calibrator were determined and traced to a recognized reference standard (Reference Preparation for Human Serum Proteins). This is a common and appropriate method for establishing the "truth" for calibrator values.

8. The sample size for the training set

N/A. This device does not use a training set in the context of machine learning or AI.

9. How the ground truth for the training set was established

N/A. As above, no training set in the context of machine learning. The "ground truth" for the calibrator's composition is linked to Reference Material (RPPHS).

Summary

{0}------------------------------------------------

K 983469

NOV 25 1998

510(k) Summary

Introduction	According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.
1) Submitter name, address, contact	Boehringer Mannheim Corporation9115 Hague RdIndianapolis. IN 46250(317) 845-2386Contact person: Priscilla A. HamillDate prepared: September 28, 1998
2) Device name	Proprietary name: Preciset® Serum ProteinsCommon name: Preciset® Serum ProteinsClassification name: Calibrator, Multi-analyte mixture
3) Predicate device	We claim substantial equivalence to C.f.a.s. Protein Calibrator. The intended use of the above calibrators is the establishment of calibration curves for test systems for the quantitative determination of proteins in serum and plasma.
4) Device description	The Preciset® Serum Proteins consists of multi-level calibrators based on human serum. The concentrations of the components have been adjusted to ensure optimal calibration of the following immunoturbidimetric assays: Tina-quant® IgA, Tina-quant® IgG, Tina-quant® IgM, Tina-quant ® C3, and Tina-quant ® C4.
5) Intended use	The Preciset® Serum Proteins calibrator is intended to be used in the calibration of immunoturbidimetric assays on the BM/Hitachi systems.
6) Comparisonto the predicatedevice	The Preciset ® Serum Proteins calibrator is substantially equivalent to otherproducts in commercial distribution intended for similar use. Most notably, itis substantially equivalent to the currently marketed Boehringer MannheimC.f.a.s. Protein calibrator.
	The intended use of this BM calibrator and the predicate devices is the samein that they are intended to be used for the calibration of test systems for themeasurement of their labeled analytes.
Representativeconstituentlevels andreferencematerials	Representative constituent levels and the corresponding referencematerial/method are given in the table below.
	Representative Constituent Levels, Reference Materials, andUnits

{1}------------------------------------------------

510(k) Summary, Continued

Constituent	Level 1	Level 2	Level 3	Level 4	Level 5	Reference Material	Units
IgG	215	454	982	1859	3755	RPPHS	mg/mL
IgA	56	108	236	470	941	RPPHS	mg/mL
IgM	46	88	181	361	724	RPPHS	mg/mL
C3	40	74	159	330	NA	RPPHS	mg/mL
C4	6.5	12.8	27.5	56.0	110.6	RPPHS	mg/mL

{2}------------------------------------------------

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread, formed by three human profiles facing to the right.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV 25 1998

Ms. Pricilla A. Hamill Requlatory Affairs Consultant BOEHRINGER MANNHEIM CORPORATION 9115 Haque Road P.O. Box 50457 Indianapolis, IN 46250

Re: K983469 Trade Name: Preciset® Serum Proteins Requlatory Class: II Product Code: 75 JIX September 28, 1998 Dated: Received: October 01, 1998

Dear Ms. Hamill:

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 Requlations, 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 requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. this response to your premarket notification Please note: 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.

{3}------------------------------------------------

Page 2

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, "Misbrandinq 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 Putman

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}------------------------------------------------

K983469 510(k) Number (if known): ___________________________________________________________________________________________________________________________________________________

Device Name: Preciset ® Serum Proteins

Indications for Use: For calibration of immunoturbidimetric assays on BM/Hitachi systems

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IS 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)

Shan F. Logsdon
(Division Sign-Off)

Division of Clinical Laboratory Devices
510(k) Number K983469

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.