Predicate Devices

K862019, K 862386

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes an in vitro diagnostic immunoassay reagent kit for use with a specific instrument. There is no mention of AI/ML in the intended use, device description, or performance studies. The performance studies focus on standard analytical validation metrics for IVD assays (method comparison, stability, imprecision).

Therapeutic

No

This device is for quantitative determination of apolipoprotein levels in human serum, which is an in vitro diagnostic (IVD) test, not a therapeutic intervention.

Diagnostic

Yes
The device is described as being for "quantitative determination of apolipoprotein A-1 and B in human serum samples by nephelometric immunoassay," which is a measurement intended to provide information for diagnosis or monitoring.

SaMD (Software as a Medical Device)

No

The device is described as reagents for use with a specific immunochemistry system (IMMAGE System), indicating it is a physical component (reagents) used in conjunction with hardware, not a standalone software application.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The "Intended Use / Indications for Use" section explicitly states that the reagents are "intended for use in the quantitative determination of apolipoprotein A-1 and B in human serum samples by nephelometric immunoassay." This describes a test performed on a biological sample (human serum) outside of the body to provide information about a person's health status.
Device Description: The "Device Description" further clarifies that the reagents are used for "quantitative determination of apolipoprotein A-1 and B concentrations in human serum samples."
Performance Studies: The "Summary of Performance Studies" describes studies like method comparison, stability, and imprecision experiments, which are typical performance evaluations for IVD devices.
Predicate Devices: The mention of "Predicate Device(s)" with K numbers (K862019 and K862386) indicates that this device is being compared to other legally marketed IVD devices.

All of these points align with the definition and characteristics of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The IMMAGE Immunochemistry System Apoliooprotein A-1 (APA) and B (APB) Reagents, in conjunction with Beckman Apolipoprotein Calibrator (APO Cal), are intended for use in the quantitative determination of apolipoprotein A-1 and B in human serum samples by nephelometric immunoassay. These assays are designed for use with the IMMAGE Immunochemistry System.

Product codes (comma separated list FDA assigned to the subject device)

Not Found

Device Description

The IMMAGE System Apolipoprotein A-1 (APA) and B (APB) Reagents are designed for optimal performance on the IMMAGE Immunochemistry System. They are intended for use in the quantitative determination of apolipoprotein A-1 and B concentrations in human serum samples.

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. Equivalence is demonstrated through method companson, stability, and imprecision experiments that relate results obtained from the Beckman Immunochemistry Systems Apolipoprotein A-1 and B Reagents to the IMMAGE APA & APB Reagents.

Method Comparison Study Results IMMAGE APA & APB Reagents vs. Beckman Apolipoprotein A-1 and B Reagents

IMMAGE APA: Slope 0.998, Intercept 1.86, r 0.983, Predicate: Beckman Apolipoprotein A-1 Reagent on the ARRAY
IMMAGE APB: Slope 1.030, Intercept -1.34, r 0.991, Predicate: Beckman Apolipoprotein B Reagent on the ARRAY

Stability Study Results

IMMAGE APA: 24 months shelf-life, 14-day on board, 14 day calibration stability
IMMAGE APB: 24 months shelf-life, 14 open container stability, 14 day calibration stability

Estimated Within-Run Imprecision

APA Reagent:
- Level 1: MEAN 56.7 mg/dL, SD 3.12 mg/dL, %CV 5.5, Number of Results 80
- Level 2: MEAN 105 mg/dL, SD 3.4 mg/dL, %CV 3.2, Number of Results 80
- Level 3: MEAN 167 mg/dL, SD 4.8 mg/dL, %CV 2.9, Number of Results 80
APB Reagent:
- Level 1: MEAN 55.7 mg/dL, SD 1.78 mg/dL, %CV 3.2, Number of Results 80
- Level 2: MEAN 115 mg/dL, SD 2.9 mg/dL, %CV 2.5, Number of Results 80
- Level 3: MEAN 186 mg/dL, SD 4.6 mg/dL, %CV 2.5, Number of Results 80

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.

K862019, K 862386

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

Regulation Number and Section

§ 862.1475 Lipoprotein test system.

(a)
Identification. A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.

Summary

0

Image /page/0/Picture/1 description: The image shows the word "BECKMAN" in bold, black letters. The font is sans-serif and the letters are evenly spaced. The word is likely a brand name or a proper noun.

FEB

10

1997

K964010

Summary of Safety & Effectiveness IMMAGE™ Immunochemistry System Apolipoprotein A-1 (APA) and B (APB) Reagents

1.0 Submitted By:

Margie George Project Manager, Systems Development Beckman Instruments, Inc. 200 S. Kraemer Blvd., W-337 Brea, California 92822-8000 Telephone: (714) 961-3765 FAX: (714) 961-3759

2.0 Date Submitted:

03 Oct 1996

3.0 Device Name(s):

3.1 Proprietary Names

IMMAGE™ Immunochemistry System Apolipoprotein A-1 Reagent IMMAGE™ Immunochemistry System Apolipoprotein B Reagent

3.2 Classification Names

Lipoprotein test system (21 CFR 862.1475)

4.0 Predicate Device(s):

Beckman Immunochemistry Systems Apolipoprotein A-1 Reagent, K862019 Beckman Immunochemistry Systems Apolipoprotein B Reagent, K 862386

5.0 Description:

The IMMAGE System Apolipoprotein A-1 (APA) and B (APB) Reagents are designed for optimal performance on the IMMAGE Immunochemistry System. They are intended for use in the quantitative determination of apolipoprotein A-1 and B concentrations in human serum samples.

6.0 Intended Use:

The IMMAGE Immunochemistry System Apoliooprotein A-1 (APA) and B (APB) Reagents, in conjunction with Beckman Apolipoprotein Calibrator (APO Cal), are intended for use in the quantitative determination of apolipoprotein A-1 and B in human serum samples by nephelometric immunoassay. These assays are designed for use with the IMMAGE Immunochemistry System.

Beckman Instruments, Inc.

1

7.0 Comparison to Predicate(s):

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

Reagent	Aspect/Characteristic	Comments
SIMILARITIES
IMMAGE System APA Reagent	Assay method - rate nephelometry	Same as Beckman
Immunochemistry Systems
Apolipoprotein A-1 Reagent
	Sample/reagent ratios
	Measuring Range:
Initial 25 - 255 mg/dL
Extended 25 - 450 mg/dL
	Antibody
DIFFERENCES
IMMAGE System APA Reagent	Reaction Temperature	IMMAGE System APA assay
runs at 37°C and the predicate
runs at 26.7°C.
	Reagent Container	IMMAGE reagent is stored in a
plastic cartridge and the
predicate reagent is stored in
glass vials.

Reagent	Aspect/Characteristic	Comments
SIMILARITIES
IMMAGE System
APB Reagent	Assay method - rate nephelometry	Same as Beckman
Immunochemistry Systems
Apolipoprotein B Reagent
	Sample/reagent ratios
	Measuring Range:
Initial 35 - 255 mg/dL
Extended 35 - 450 mg/dL
	Antibody
DIFFERENCES
IMMAGE System
APB Reagent	Reaction Temperature	IMMAGE System APB assay
runs at 37°C and the predicate
runs at 26.7°C.
	Reagent Container	IMMAGE reagent is stored in a
plastic cartridge and the
predicate reagent is stored in
glass vials.

2

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 Immunochemistry Systems Apolipoprotein A-1 and B Reagents to the IMMAGE APA & APB Reagents.

Method Comparison Study Results IMMAGE APA & APB Reagents vs. Beckman Apolipoprotein A-1 and B Reagents

Analyte	Slope	Intercept	r	Predicate
IMMAGE
APA	0.998	1.86	0.983	Beckman
Apolipoprotein
A-1 Reagent on
the ARRAY
IMMAGE
APB	1.030	-1.34	0.991	Beckman
Apolipoprotein
B Reagent on
the ARRAY

Stability Study Results

Reagent	Product Claim
IMMAGE APA	24 months shelf-life
14-day on board
14 day calibration stability
IMMAGE APB	24 months shelf-life
14 open container stability
14 day calibration stability

Estimated Within-Run Imprecision

| Material | MEAN
(mg/dL) | SD
(mg/dL) | %CV | Number of
Results |
|----------|-----------------|---------------|-----|----------------------|
| | APA Reagent | | | |
| Level 1 | 56.7 | 3.12 | 5.5 | 80 |
| Level 2 | 105 | 3.4 | 3.2 | 80 |
| Level 3 | 167 | 4.8 | 2.9 | 80 |
| | APB Reagent | | | |
| Level 1 | 55.7 | 1.78 | 3.2 | 80 |
| Level 2 | 115 | 2.9 | 2.5 | 80 |
| Level 3 | 186 | 4.6 | 2.5 | 80 |

3

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.

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