The IMMAGE Immunochemistry System Complement C3 (C3) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 1, is intended for the quantitative determination of Complement C3 by rate nephelometry.

The IMMAGE Immunochemistry System Complement C4 (C4) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 1, is intended for the quantitative determination of Complement C4 by rate nephelometry.

The IMMAGE Immunochemistry System Complement C4 (C4) Reagent, when used in coniunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 1. is intended for the quantitative determination of human complement C4 by rate nephelometry.

Device Description

The IMMAGE Immunochemistry System C3 and C4 Reagents in conjunction with Beckman Calibrator 1, are intended for use in the quantitative determination of Complement C3 and Complement C4 concentrations respectively in human serum samples on Beckman's IMMAGE Immunochemistry System.

AI/ML Overview

This document describes the IMMAGE™ Immunochemistry System Complement C3 (C3) and Complement C4 (C4) Reagents. The information provided is for regulatory clearance (510(k) submission) and focuses on demonstrating substantial equivalence to predicate devices, rather than establishing de novo acceptance criteria for an entirely new technology. Therefore, the "acceptance criteria" here are implicitly tied to the performance of the predicate device and generally accepted laboratory performance standards for such assays.

Here's an analysis of the provided text in the requested format:

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

Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance (C3)	Reported Device Performance (C4)
Method Comparison	Agreement with predicate method (e.g., strong correlation, slope ≈ 1, intercept ≈ 0)	Slope: 0.969, Intercept: 6.18, r: 0.994 (n=100)	Slope: 0.983, Intercept: -1.48, r: 0.984 (n=124)
Stability	Meet product claims for shelf-life, open-container, and calibration	24 month shelf-life, 14 day open container stability, 14 day calibration stability	24 month shelf-life, 14 day open container stability, 14 day calibration stability
Imprecision (Within-Run)	Low Coefficient of Variation (CV)	Level 1: 2.5% CV (Mean 70.3 mg/dL) Level 2: 2.9% CV (Mean 106 mg/dL)	Level 1: 3.2% CV (Mean 18.8 mg/dL) Level 2: 3.4% CV (Mean 42.9 mg/dL) Level 3: 2.5% CV (Mean 65.5 mg/dL)
Imprecision (Total)	Low Coefficient of Variation (CV)	Level 1: 3.0% CV (Mean 70.3 mg/dL) Level 2: 3.6% CV (Mean 106 mg/dL)	Level 1: 3.4% CV (Mean 18.8 mg/dL) Level 2: 5.2% CV (Mean 42.9 mg/dL) Level 3: 3.7% CV (Mean 65.5 mg/dL)

Note: The document states "Equivalence is demonstrated through method comparison, stability, and imprecision experiments that relate results obtained from the Beckman Reagents to the IMMAGE System Reagents." The specific numerical acceptance criteria (e.g., minimum 'r' value, maximum %CV) are not explicitly stated but are implicitly met by the reported results being considered sufficient for substantial equivalence.

2. Sample sized used for the test set and the data provenance

Method Comparison Test Set Sample Size:
- Complement C3: 100 samples
- Complement C4: 124 samples
Imprecision Study Sample Size: For both C3 and C4, 80 replicates were used per level for each precision type (within-run and total precision). This typically involves multiple runs over several days.
Data Provenance: Not explicitly stated, but based on the manufacturer's location (Brea, California, USA) and the context of a 510(k) submission in the US, it is highly probable that the studies were conducted in the USA using human serum samples. The data is retrospective in the sense that it's analyzed after the experiments are conducted to demonstrate performance. The nature of these in vitro diagnostic (IVD) performance studies would generally be considered prospective experimentation designed to validate the device.

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

This type of IVD device (quantitative determination of complement proteins) does not typically involve "experts" establishing a subjective ground truth for a test set. The "ground truth" for the method comparison study is the result obtained from the predicate device (Beckman's Immunochemistry Systems Complement C3 Reagent on the Array for C3, and Complement C4 Reagent on the Array for C4). These predicate devices are already established and accepted for their performance in quantifying C3 and C4.

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

Not applicable. As described above, this is an IVD device measuring quantitative analytes. Ground truth is established by a reference method (the predicate device), not through expert adjudication of images or clinical cases.

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

Not applicable. This is not an AI-assisted diagnostic device, nor does it involve "human readers" in the sense of interpreting medical images or clinical scenarios that would warrant an MRMC study. It is an automated immunochemistry system for quantitative measurement.

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

Yes, the studies presented (method comparison, stability, imprecision) demonstrate the "standalone" performance of the IMMAGE™ Immunochemistry System C3 and C4 Reagents when run on the IMMAGE™ system. The performance metrics are derived directly from the instrument's output.

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

The ground truth for the method comparison was the results obtained from the legally marketed predicate devices (Beckman Immunochemistry Systems Complement C3 and C4 Reagents on the Array System). For the stability and imprecision studies, the ground truth is inherently the true concentration of the analyte in the control/sample material, which is typically established through rigorous characterization and reference methods.

8. The sample size for the training set

This document does not describe a "training set" in the context of machine learning or AI. This is a traditional IVD device, and the method comparison and precision studies involve "test sets" for performance validation.

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

Not applicable, as there is no "training set" in the context of this traditional IVD device.

Summary

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

K964842

BECKMAN

Summary of Safety & Effectiveness IMMAGE™ Immunochemistry System Complement C3 (C3) and Complement C4 (C4) Reagents

1.0 Submitted By:

Margie George Project Manager Beckman Instruments, Inc. 200 S. Kraemer Blvd., W-343 Brea, California 92822-8000 Telephone: (714) 961-3765 FAX: (714) 961-3759

2.0 Date Submitted:

26 November 1996

3.0 Device Name(s):

3.1 Proprietary Names

IMMAGE™ Immunochemistry System Complement C3 (C3) Reagent IMMAGE™ Immunochemistry System Complement C4 (C4) Reagent

3.2 Classification Name

Complement components) immunological test system (21 CFR § 866.5240)

4.0 Predicate Device(s):

IMMAGE SystemReagent	Predicate	Manufacturer	DocketNumber
Complement C3 (C3 )Reagent	ImmunochemistrySystems ComplementC3 Reagent	Beckman InstrumentsInc.*	K771603
Complement C4 (C4)Reagent	ImmunochemistrySystems ComplementC4 Reagent	Beckman InstrumentsInc.*	K780913

Beckman Instruments, Inc.

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

Beckman Instruments, Inc., Section 510(k) Notification IMMAGE™ Immunochemistry System Complement C3 (C3) and Complement C4 (C4) Reagents Summary of Safety & Effectiveness

5.0 Description:

6.0 Intended Use:

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

Beckman Instruments, Inc., Section 510(k) Notification Beckman mstranients, mc., Geclon 3 ro(x) Netwould.
IMMAGE™ Immunochemistry System Complement C3 (C3) and Complement C4 (C4) Reagents Summary of Safety & Effectiveness

7.0 Comparison to Predicate(s):

The following tables show similarities and differences between the predicates identified in Section 4.0 of this summary.

Reagent	Aspect/Characteristic	Comments
IMMAGE System C3Reagent	Assay method - rate nephelometry	Same as Beckman'sImmunochemistry Systems
	Sample / reagent ratios	Complement C3 reagent on theArray System
	Antibody

C3 Similarities With The Predicate

C4 Similarities With The Predicate

Reagent	Aspect/Characteristic	Comments
IMMAGE System C4Reagent	Assay method - rate nephelometry	Same as Beckman'sImmunochemistry Systems
	Sample / reagent ratios	Complement C4 reagent on theArray System
	Measuring Range:Initial 10 - 130 mg/dLExtended 10 - 4,680 mg/dL
	Antibody

C3 Differences From The Predicate

Reagent	Aspect/Characteristic	Comments
IMMAGE SystemC3 Reagent	Reaction Temperature	IMMAGE System C3 assays run at 37°Cand the predicate runs at 26.7°C.
IMMAGE SystemC3 Reagent	Reagent Container	IMMAGE reagent is stored in a plasticcartridge and predicate reagent is stored inglass vials.

C4 Differences From The Predicate

Reagent	Aspect/Characteristic	Comments
IMMAGE SystemC4 Reagent	Reaction Temperature	IMMAGE System C4 assays run at 37°C andthe predicate runs at 26.7°C.
IMMAGE SystemC4 Reagent	Reagent Container	IMMAGE reagent is stored in a plasticcartridge and predicate reagent is stored inglass vials.

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

Summary of Performance Data: 8.0

The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. Equivalence is demonstrated through method companson, stability, and imprecision experiments that relate results obtained from the Beckman Reagents to the IMMAGE System Reagents.

Analyte	Sample Type	Slope	Intercept	r	n	Predicate Method
Complement C3	serum	0.969	6.18	0.994	100	Complement C3 Reagent on the Array
Complement C4	serum	0.983	-1.48	0.984	124	Complement C4 Reagent on the Array

Method Comparison Study Results IMMAGE Complement C3 (C3) and Complement C4 (C4) Reagents

Stability Study Results

Reagent	Product Claim
IMMAGE C3 & C4	24 month shelf-life14 day open container stability14 day calibration stability

{4}------------------------------------------------

Estimated Imprecision

IMMAGE System C3 Reagent Precision Study Results

Sample	Mean (mg/dL)	S.D. (mg/dL)	%C.V.	N
Within-Run Imprecision
Level 1	70.3	1.79	2.5	80
Level 2	106	3.1	2.9	80
Total Precision
Level 1	70.3	2.09	3.0	80
Level 2	106	3.9	3.6	80

IMMAGE System C4 Reagent Precision Study Results

Sample	Mean (mg/dL)	S.D. (mg/dL)	%C.V.	N
		Within-Run Imprecision
Level 1	18.8	0.60	3.2	80
Level 2	42.9	1.45	3.4	80
Level 3	65.5	1.65	2.5	80
		Total Precision
Level 1	18.8	0.65	3.4	80
Level 2	42.9	2.21	5.2	80
Level 3	65.5	2.46	3.7	80

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 regulation 21 CFR 807.92.

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle with a caduceus, a symbol associated with medicine and healthcare, superimposed on its body.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

1997 IIN III

Ms. Margie George Project Manager Beckman Instruments, Inc. 200 S. Kraemer Boulevard, W-343 Brea, California 92822-8000

Re: K964842/S1

华 Trade Name: IMMAGE™ Immunochemistry System Complement C3 and C4 Reagents Regulatory Class: II Product Code: CZW DBI II Dated: March 27, 1997 Received: March 28, 1997

Dear Ms. George:

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, 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 vou might have under sections 531 through 542 of the Act for devices under the Flectronic Product Radiation Control provisions, or other Federal Laws or Regulations.

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.

{6}------------------------------------------------

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 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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours.

Steven Butman

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

{7}------------------------------------------------

page _ of _

K964842 510(k) Number (if known):

Device Name: IMMAGE™ Immunochemistry System Complement C4 (C4) Reagent

Indications for Use:

21 CFR 866,5240 Complement components immunological test system

(a) Identification. A Complement components immunological test system is a device that consists of the reagents used to measure by immunochemical techniques complement components G1g. G1, G15, G2 C3, C4, C5, Cg, and Cg in serum, other body fluids, and tissues. Complement is a group of serum proteins which destroy Measurements of these proteins aids in the diagnosis of infectious agents. immunologic disorders, especially those associated with deficiencies of complement components.

(b) Classification. Class II (performance standards).

Patrick Maher

(Division Sign-Off Division of Clinical Laborato (PLEASE DO NOT WRITE BELOW THIS LINE ! OU ANOTHER PAGE

Concurrence of CDRH, Office of Device Evaluation (ODE)

ﺎ Prescription Use (per 21 CFR 801.109)

NEEDED)

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

Regulation Number and Section

§ 866.5240 Complement components immunological test system.

(a)
Identification. A complement components immunological test system is a device that consists of the reagents used to measure by immunochemical techniques complement components C1q , C1r , C1s , C2 , C3 , C4 , C5 , C6 , C7 , C8 , and C9 , in serum, other body fluids, and tissues. Complement is a group of serum proteins which destroy infectious agents. Measurements of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.(b)
Classification. Class II (performance standards).