RF-LATEX SEIKEN REAGENT SYSTEM

K960703 · Globe Management Support, Inc. · DHR · Apr 19, 1996 · Immunology

Device Facts

• Record ID: K960703
• Device Name: RF-LATEX SEIKEN REAGENT SYSTEM
• Applicant: Globe Management Support, Inc.
• Product Code: DHR · Immunology
• Decision Date: Apr 19, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5775
• Device Class: Class 2

Intended Use

This in vitro diagnostic procedure is intended to quantitatively measure RF in human serum on the Cobas Mira chemistry analyzer. Such measurements are used in the diagnosis and treatment of rheumatoid arthritis.

Device Story

Reagent system for quantitative measurement of rheumatoid factor (RF) in human serum; utilizes latex particles coated with anti-RF (human IgG); agglutination reaction measured via absorbance change at 550 nm on Cobas Mira chemistry analyzer; RF concentration determined by interpolation from multi-point calibration curve; used in clinical laboratory settings by trained personnel; results assist clinicians in diagnosing and monitoring rheumatoid arthritis.

Clinical Evidence

Bench testing only. Accuracy evaluated by testing 92 serum samples in parallel with predicate; correlation r=0.984, y = -0.947 + 1.053x. Precision assessed via within-run (n=10 replicates) and between-run (10 days) studies; CVs < 2%. Linearity confirmed across 3-120 IU/ml range using 3 reagent lots. Stability tested over 15 months at 4°C.

Technological Characteristics

Latex agglutination immunoassay; reagents contain latex particles coated with anti-RF (human IgG); endpoint calculation method; 550 nm wavelength; multi-point calibration; intended for use on automated chemistry analyzers (e.g., Cobas Mira).

Indications for Use

Indicated for the quantitative measurement of rheumatoid factor (RF) in human serum to aid in the diagnosis and treatment of rheumatoid arthritis.

Regulatory Classification

Identification

A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.

Predicate Devices

• quantex RF plus (BIOKIT USA, Inc.)

Submission Summary (Full Text)

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K960703 APR 19 1996

# SUMMARY OF SAFETY AND EFFECTIVENESS

## RF-LATEX "SEIKEN" on the Cobas Mira Chemistry Analyzer

Below summarizes and compares the performance of RF LATEX "SEIKEN" and a similar device previously given FDA clearance for marketing in the US. The information contained in this summary was obtained from data prepared at and which is on file at Denka Seiken, Co. Inc. The summary shows that the two reagent systems are substantially equivalent.

## INTENDED USE

This *in vitro* diagnostic procedure is intended to quantitatively measure RF in human serum on the Cobas Mira chemistry analyzer. Such measurements are used in the diagnosis and treatment of rheumatoid arthritis.

| METHOD | RF-LATEX "SEIKEN" | quantex RF plus
BIOKIT USA, Inc.
113 Hartwell Avenue
Lexington, MA 02173 |
| --- | --- | --- |
| Product Code | 602534 | 3000-2095 |
| Min. Detectable Conc. | 3 IU/ml | 5 IU/ml |
| Precision (Between-run) | 20.3 IU/ml 5.23%
40.2 IU/ml 3.14%
59.2 IU/ml 1.26% | less than 10% |
| Linearity | 3 - 120 IU/ml | 5 - 100 IU/ml |
| Correlation | y = -0.947 + 1.053x
y = RF-LATEX "SEIKEN"
x = quantex RF plus
r = 0.984
n = 92 | |

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The RF-LATEX "SEIKEN" and the quantex RF plus are similar in that both :

* Are reagent systems for the quantitation of the concentration of rheumatoid factor (RF) in human serum.
* Are based on the agglutination of RF in serum with latex particles coated with anti-RF (human IgG).
* Employ the absorbance change observed as the basis for quantitation.
* Calculate the amount of RF by interpolation from a calibration curve prepared from calibrators of known concentration.
* Are intended for use with the Cobas Mira chemistry analyzer (or other suitable analyzer).

The RF-LATEX "SEIKEN" and the quantex RF plus are different in that:

* The minimal detectable concentration for the RF-LATEX "SEIKEN" is 3 IU/ml; that for the quantex RF plus is 5 IU/ml.
* The maximum quantifiable concentration for the RF-LATEX "SEIKEN" system is 120 IU/ml; that for the quantex RF plus is 100 IU/ml.

The following further summarizes similarities and differences between the two reagent systems.

| RF | RF-LATEX "SEIKEN" | quantex RF plus |
| --- | --- | --- |
| S.VOL (ul) | 6 | 6 |
| REAGENT VOL (R1) (ul) | 180 | 350 |
| START R1 VOL (R2) (ul) | 60 | 50 |
| CALC. STEP | ENDPOINT | ENDPOINT |
| STD | MULTI (5) | MULTI (4) |
| UNIT | IU/ml | IU/ml |
| WAVELENGTH | 550 nm | 550 nm |

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# PROTOCOL AND DATA SUMMARY

This section provides data generated by Denka Seiken Co., Ltd. characterizing the performance of the RF-LATEX "SEIKEN" Reagent System. The protocols used for data generation are given below, and the results are attached.

## ACCURACY

Ninety two serum samples with values spanning the reportable range for the assay were obtained and tested in parallel using the RF-LATEX "SEIKEN" and the quantex RF plus Reagent System.

## PRECISION

Within run precision was determined by analyzing ten replicates each of five levels of commercial control serum. Between run precision was determined by analyzing three levels of commercial control serum once per day for ten days.

## LINEARITY

Linearity was determined by analyzing a series of six calibrators, covering the reportable range of the assay, with 3 separate lot numbers of reagents.

## STABILITY

Stability was determined by analyzing three levels of commercial control serum at three month intervals over the shelf life of two lot numbers of reagents.

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# CORRELATION

## quantex RF Plus / RF-LATEX "SEIKEN"


Correlation: quantex RF plus / RF-LATEX "SEIKEN"

NUMBER OF CASES : 92
INTERCEPT (a) = -0.94678
r = 0.9840

REGRESSION EQUATION: $y = a + bX$
SLOPE (b) = 1.0532006
$r^2 = 0.9683$

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# RF-LATEX "SEIKEN"

## PRECISION (WITHIN-RUN)

NO. OF CUPS SELECTED THAT WERE RUN = 10
RUN PRECISION ON CONC. DATA IN IU / ML

| SAMPLE NO. | MEAN | SD | C.V. % |
| --- | --- | --- | --- |
| 1 | 10.29 | 0.30 | 2.95 |
| 2 | 19.85 | 0.18 | 0.91 |
| 3 | 29.51 | 0.33 | 1.11 |
| 4 | 39.00 | 0.55 | 1.41 |
| 5 | 48.37 | 0.69 | 1.43 |

## PRECISION (BETWEEN-RUN)

| DAY | IU/ml | | |
| --- | --- | --- | --- |
| | Sample 1 | Sample 2 | Sample 3 |
| 1 | 10.5 | 19.6 | 38.0 |
| 2 | 10.6 | 20.1 | 37.6 |
| 3 | 10.6 | 19.8 | 37.2 |
| 4 | 10.2 | 19.7 | 37.8 |
| 5 | 10.4 | 20.1 | 37.8 |
| 6 | 10.5 | 19.5 | 37.0 |
| 7 | 10.8 | 20.4 | 39.2 |
| 8 | 10.5 | 19.9 | 37.6 |
| 9 | 10.5 | 19.9 | 37.2 |
| 10 | 10.3 | 19.6 | 37.8 |
| Average | 10.49 | 19.86 | 37.72 |
| SD | 0.17 | 0.28 | 0.61 |
| C.V. % | 1.59 | 1.41 | 1.62 |

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# LINEARITY

| IU/ml | IU/ml | | | |
| --- | --- | --- | --- | --- |
| | Lot. 1 | Lot. 2 | Lot.3 | Average |
| 20.0 | 10.4 | 10.0 | 9.3 | 9.9 |
| 40.0 | 19.3 | 21.2 | 19.0 | 19.8 |
| 60.0 | 28.1 | 28.2 | 28.4 | 28.2 |
| 80.0 | 39.1 | 38.6 | 38.7 | 38.8 |
| 100.0 | 47.6 | 49.0 | 49.7 | 48.8 |
| 120.0 | 59.3 | 60.0 | 58.4 | 59.2 |
| A = | -0.07 | 0.12 | -0.87 | -0.29 |
| B = | 0.973 | 0.982 | 0.994 | 0.983 |
| r = | 0.9989 | 0.9996 | 0.9996 | 0.9995 |
| y = A + B x | | | | |

# STABILITY Stored at 4 °C

| MONTH | Lot. 1 (IU/ml) | | | Lot.2 (IU/ml) | | |
| --- | --- | --- | --- | --- | --- | --- |
| | Sample 1 | Sample 2 | Sample 3 | Sample 1 | Sample 2 | Sample 3 |
| 0 | 10.2 | 19.4 | 39.5 | 11.8 | 18.4 | 39.7 |
| 3 | 10.4 | 19.3 | 39.3 | 9.3 | 18.4 | 38.6 |
| 6 | 10.4 | 19.9 | 37.7 | 9.7 | 18.2 | 39.3 |
| 12 | 10.7 | 19.2 | 37.4 | 9.8 | 17.8 | 37.6 |
| 15 | 10.0 | 19.0 | 36.3 | 9.5 | 17.6 | 38.1 |