Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a reagent and a traditional immunochemistry system using rate nephelometry, with no mention of AI or ML terms or concepts.

Therapeutic

No
The device is described as a reagent for quantitative determination of alpha-1-microglobulin in urine, indicating it is an in-vitro diagnostic device used for measurement, not for treating or curing a disease.

Diagnostic

Yes
The device is intended for the quantitative determination of alpha-1-microglobulin in urine, which is a measurement used for diagnostic purposes. It provides data (analyte levels) that can aid in the diagnosis or monitoring of medical conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "Reagent" and is used in conjunction with a physical "Immunochemistry System" and "Calibrator," indicating it is a chemical/biological component, not software.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use explicitly states it's for the "quantitative determination of alpha-1-microglobulin in urine by rate nephelometry." This involves testing a sample (urine) taken from the human body in vitro (outside the body) to provide information about a patient's health status.
Device Description: The description reinforces that it's used for the "quantitative determination of alpha-1-Other Fotom Calibration is interesmples on Beckman's IMMAGE™ Immunochemistry System." This again points to testing biological samples outside the body.
Performance Studies: The performance studies describe method comparison, stability, and imprecision experiments using urine samples, which are typical evaluations for IVD devices.
Predicate Device: The predicate device listed (K933078 Beckman Alpha-1-Microglobulin A1M Reagent) is also an IVD, indicating that this type of product falls under the IVD category.

The core function of the device is to analyze a biological sample (urine) to measure a specific substance (alpha-1-microglobulin) for diagnostic purposes, which is the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The IMMAGE Immunochemistry System Alpha-1-Microglobulin (A1M) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Urine Protein Calibrator, is intended for the quantitative determination of of alpha-1-microglobulin in urine by rate nephelometry.

Product codes

Not Found

Device Description

The IMMAGE Immunochemistry System A1M Reagent in conjunction with Beckman Urine Protein Calibrator, is intended for use in the quantitative determination of alpha-1-Other Fotom Calibration is interesmples on Beckman's IMMAGE™ Immunochemistry System.

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 comparison, stability, and imprecision experiments that relate results obtained from the Beckman Reagent on the Array® 360 System to the IMMAGE System Reagent.

Method Comparison Study Results:
Analyte: IMMAGE A1M Reagent
Sample Type: Urine
Slope: 0.961
Intercept: 0.10
r: 0.993
n: 123
Predicate Method: Beckman Alpha-1-Microglobulin Reagent

Stability Study Results:
IMMAGE: month shelf-life, day open container stability, day calibration stability

Estimated Imprecision:
Within-Run Imprecision:
Level 1: Mean (mg/dL) 0.77, S.D. (mg/dL) 0.021, %C.V. 2.8, N 80
Level 2: Mean (mg/dL) 3.05, S.D. (mg/dL) 0.056, %C.V. 1.8, N 80
Level 3: Mean (mg/dL) 6.59, S.D. (mg/dL) 0.161, %C.V. 2.4, N 80
Total Imprecision:
Level 1: Mean (mg/dL) 0.77, S.D. (mg/dL) 0.031, %C.V. 4.1, N 80
Level 2: Mean (mg/dL) 3.05, S.D. (mg/dL) 0.061, %C.V. 2.0, N 80
Level 3: Mean (mg/dL) 6.59, S.D. (mg/dL) 0.194, %C.V. 2.9, N 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.

K933078

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

Not Found

Regulation Number and Section

§ 866.5400

Alpha -globulin immunological test system.(a)
Identification. Analpha- globulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques thealpha- globulin (a serum protein) in serum and other body fluids. Measurement ofalpha- globulin may aid in the diagnosis of inflammatory lesions, infections, severe burns, and a variety of other conditions.(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 § 866.9.

Summary

0

BECKMAN

APR 21 1997

K965033 Summary of Safety & Effectiveness

IMMAGE™ Immunochemistry System Alpha-1-Microglobulin (A1M) Reagent

1.0 Submitted By:

Annette Hellie 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:

16 December 1996

Device Name(s): 3.0

3.1 Proprietary Names

IMMAGE™ Immunochemistry System Alpha-1-Microglobulin (A1M) Reagent

Classification Name 3.2

Not classified

Predicate Device(s): 4.0

| IMMAGE System
Reagent | Predicate | Manufacturer | Docket
Number |
|---------------------------------------------------------|--------------------------------------------------|------------------------------|------------------|
| IMMAGE System
Alpha-1-Microglobulin
(A1M) Reagent | Beckman Alpha-1-
Microglobulin A1M
Reagent | Beckman Instruments,
Inc. | K933078 |

Beckman Instruments, Inc.

1

Beckman Instruments, Inc., Section 510(k) Notification IMMAGE™ Immunochemistry System Alpha-1-Microglobulin (A1M) Reagent Summary of Safety & Effectiveness

5.0 Description:

The IMMAGE Immunochemistry System A1M Reagent in conjunction with Beckman Urine Protein Calibrator, is intended for use in the quantitative determination of alpha-1-Other Fotom Calibration is interesmples on Beckman's IMMAGE™ Immunochemistry System.

Intended Use: 6.0

The IMMAGE Immunochemistry System Alpha-1-Microglobulin (A1M) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Urine Protein Calibrator, is intended for the quantitative determination of of alpha-1-microglobulin in urine by rate nephelometry.

Comparison to Predicate(s): 7.0

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 A1M Reagent	Analytic Range	Same as Beckman Alpha-1-Microglobulin Reagent
IMMAGE System A1M Reagent	Nephelometric methodology
IMMAGE System A1M Reagent	Antibody source (goat)
DIFFERENCES
IMMAGE System A1M Reagent	Antigen excess testing	IMMAGE A1M has antigen excess testing solution included in the reagent cartridge, while the Beckman Alpha-1-Microglobulin Reagent requires off-line preparation of the solution.
IMMAGE System A1M Reagent	Antibody concentration	IMMAGE A1M has a higher antibody concentration than the Beckman Alpha-1-Microglobulin Reagent

2

Beckman Instruments, Inc., Section 510(k) Notification IMMAGE™ Immunochemistry System Alpha-1-Microglobulin (A1M) Reagent Summary of Safety & Effectiveness

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 comparison, stability, and imprecision experiments that relate results obtained from the Beckman Reagent on the Array® 360 System to the IMMAGE System Reagent.

Method Comparison Study Results IMMAGE Alpha-1-Microglobulin (A1M) Reagent

Analyte	Sample Type	Slope	Intercept	r	n	Predicate Method
IMMAGE
A1M
Reagent	Urine	0.961	0.10	0.993	123	Beckman
Alpha-1-Microglobulin
Reagent

Stability Study Results

| Reagent Career State | coduct Claim
State of the state of the state of the state of the states of the states of the states of the states of the states of the states of the states of the states of the state of t | | |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| IMMAGE | month shelf-life | | |
| | day open container stability | | |
| | day calibration stability | | |

Estimated Imprecision

Sample	Mean (mg/dL)	S.D. (mg/dL)	%C.V.	N
Within-Run Imprecision
Level 1	0.77	0.021	2.8	80
Level 2	3.05	0.056	1.8	80
Level 3	6.59	0.161	2.4	80
Total Imprecision
Level 1	0.77	0.031	4.1	80
Level 2	3.05	0.061	2.0	80
Level 3	6.59	0.194	2.9	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.

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