IMMAGE IMMUNOCHEMISTRY SYSTEM HAPTOGLOBIN (HPT) REAGENT

K963286 · Beckman Instruments, Inc. · DAD · Oct 7, 1996 · Immunology

Device Facts

• Record ID: K963286
• Device Name: IMMAGE IMMUNOCHEMISTRY SYSTEM HAPTOGLOBIN (HPT) REAGENT
• Applicant: Beckman Instruments, Inc.
• Product Code: DAD · Immunology
• Decision Date: Oct 7, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5460
• Device Class: Class 2

Intended Use

The IMMAGE Immunochemistry System Haptoglobin (HPT) reagent, in conjunction with Beckman Calibrator 1, is intended for use in the quantitative determination of human haptoglobin concentrations in human serum samples by rate nephelometry. This assay is designed for use with Beckman's IMMAGE Immunochemistry System.

Device Story

The IMMAGE Immunochemistry System Haptoglobin (HPT) reagent is an in vitro diagnostic assay used on the Beckman IMMAGE Immunochemistry System. It measures haptoglobin concentrations in human serum samples using rate nephelometry. The system automates the reaction process, which occurs at 37°C, utilizing a prediluted antigen excess solution (AGXS) contained within the reagent cartridge. The device is intended for use in clinical laboratory settings by trained laboratory personnel. The system provides quantitative results that assist healthcare providers in assessing patient haptoglobin levels, which are relevant for diagnosing and monitoring various clinical conditions. The automated nature of the IMMAGE system streamlines the assay workflow compared to predicate systems that require off-line preparation of reagents.

Clinical Evidence

Bench testing only. Method comparison study between IMMAGE HPT and predicate (Array Systems) showed a slope of 1.004, intercept of -6.80, and r=0.996. Imprecision studies (n=80 per level) demonstrated %CVs of 1.4% (60.8 mg/dL), 2.5% (136 mg/dL), and 2.8% (322 mg/dL). Stability testing confirmed a 24-month shelf-life, 14-day open container stability, and 14-day calibration stability.

Technological Characteristics

Rate nephelometry assay; reaction temperature 37°C. Reagent includes prediluted antigen excess solution (AGXS). Analytic range 35-350 mg/dL; extended range 5.8-12,600 mg/dL. Designed for use on the IMMAGE Immunochemistry System.

Indications for Use

Indicated for the quantitative determination of haptoglobin concentrations in human serum samples to aid in the diagnosis and monitoring of conditions involving haptoglobin levels.

Regulatory Classification

Identification

A haptoglobin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the haptoglobin (a protein that binds hemoglobin, the oxygen-carrying pigment in red blood cells) in serum. Measurement of haptoglobin may aid in the diagnosis of hemolytic diseases (diseases in which the red blood cells rupture and release hemoglobin) related to the formation of hemoglobin-haptoglobin complexes and certain kidney diseases.

Special Controls

*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 § 866.9.

Predicate Devices

• Beckman Immunochemistry Systems HPT Haptoglobin Reagent

Reference Devices

• Array® Systems

Submission Summary (Full Text)

{0}

OCT 7 1996
K 96 3286

# Summary of Safety & Effectiveness

IMMAGE™ Immunochemistry System Haptoglobin (HPT) Reagent

## 1.0 Submitted By:

Margie George
Project Manager, System Development
Beckman Instruments, Inc.
200 S. Kraemer Blvd., W-337
Brea, California 92822-8000
Telephone: [phone]
FAX: [phone]

## 2.0 Date Submitted:

23 Aug-1996

## 3.0 Device Name(s):

### 3.1 Proprietary Names

IMMAGE™ Immunochemistry System Haptoglobin (HPT) Reagent

### 3.2 Classification Names

Haptoglobin immunological test system(21 CFR 866.5460)

## 4.0 Predicate Device(s):

Beckman Immunochemistry Systems HPT Haptoglobin Reagent

## 5.0 Description:

The IMMAGE Immunochemistry System Haptoglobin (HPT) reagent, in conjunction with Beckman Calibrator 1, is intended for use in the quantitative determination of human haptoglobin concentrations in human serum samples.

## 6.0 Intended Use:

The IMMAGE Immunochemistry System Haptoglobin (HPT) reagent, in conjunction with Beckman Calibrator 1, is intended for use in the quantitative determination of human haptoglobin concentrations in human serum samples by rate nephelometry. This assay is designed for use with Beckman's IMMAGE Immunochemistry System.

file: hpt510k.see

{1}

Beckman Instruments, Inc., Section 510(k) Notification
IMMAGE™ Immunochemistry System Haptoglobin (HPT) Reagent
Summary of Safety & Effectiveness

# 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 (HPT) Reagent | Assay method - rate nephelometry | Same as Beckman's HPT Haptoglobin Reagent |
| | Analytic Range 35 - 350 mg/dL
Extended Range 5.8 - 12,600 mg/dL | Same as Beckman's HPT Haptoglobin Reagent |
| | Sample and reagent ratios | Same as Beckman's HPT Haptoglobin Reagent |
| | Antibody | Same as Beckman's HPT Haptoglobin Reagent |
| | Shelf life of 24 months (stored at 2-8°C) | Same as Beckman's HPT Haptoglobin Reagent |
| DIFFERENCES | | |
| IMMAGE System (HPT) Reagent | Reaction Temperature | IMMAGE System HPT assays run at 37°C and the predicate runs at 26.7°C |
| | Antigen excess solution (AGXS) | IMMAGE System HPT Reagent AGXS is prediluted and present in the reagent cartridge while the predicate requires off-line preparation of the solution. |

file: hpt510k.sse

{2}

Beckman Instruments, Inc., Section 510(k) Notification
IMMAGE™ Immunochemistry System Haptoglobin (HPT) Reagent
Summary of Safety & Effectiveness

## 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. Equivalence is demonstrated through method comparison, stability, and imprecision experiments that relate results obtained from the Beckman Haptoglobin Reagent to the IMMAGE HPT Reagent.

### Method Comparison Study Results
IMMAGE HPT Reagent vs. Beckman Haptoglobin Reagent

| Analyte | Slope | Intercept | r | Predicate |
| --- | --- | --- | --- | --- |
| IMMAGE HPT | 1.004 | -6.80 | 0.996 | Beckman's HPT Haptoglobin Reagent on the Array® Systems |

### Stability Study Results

| Reagent | Product Claim |
| --- | --- |
| IMMAGE HPT | 24 month shelf-life
14 day open container stability
14 day calibration stability |

### Estimated Within-Run Imprecision

| MATERIAL | MEAN (mg/dL) | SD (mg/dL) | %CV | Number of Results |
| --- | --- | --- | --- | --- |
| HPT Reagent | | | | |
| Level 1 | 60.8 | 0.87 | 1.4 | 80 |
| Level 2 | 136 | 3.4 | 2.5 | 80 |
| Level 3 | 322 | 9.7 | 2.8 | 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.

file: hpt510k.sse