← Product Code [DCK](/productcode/DCK) · K960702

# CRP-LATEX SEIKEN XR REAGENT SYSTEM (K960702)

_Globe Management Support, Inc. · DCK · Apr 19, 1996 · Immunology · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K960702

## Device Facts

- **Applicant:** Globe Management Support, Inc.
- **Product Code:** [DCK](/productcode/DCK.md)
- **Decision Date:** Apr 19, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.5270
- **Device Class:** Class 2
- **Review Panel:** Immunology

## Indications for Use

This in vitro diagnostic procedure is intended to quantitatively measure CRP in human serum on the Cobas Mira chemistry analyzer. Such measurements are used in the diagnosis and treatment of bacterial infections and inflammation.

## Device Story

CRP-LATEX "SEIKEN" XR is an in vitro diagnostic reagent system for quantitative CRP measurement in human serum. Used with Cobas Mira chemistry analyzer; operates via latex agglutination principle where anti-CRP coated latex particles react with serum CRP. Absorbance change at 550 nm measured to determine concentration. Employs multistandard calibration curve (0-20 mg/dl). Results used by clinicians to assess bacterial infection and inflammation status. Benefits include rapid, automated quantification of inflammatory markers to guide clinical decision-making.

## Clinical Evidence

Bench testing only. Accuracy evaluated by comparing 122 serum samples against predicate (r=0.9976). Precision assessed via within-run (n=10, CV 2.02-3.77%) and between-run (10 days, CV 1.58-2.24%) studies. Linearity confirmed across 0.1-20.0 mg/dl range using three reagent lots (r=0.9998). Stability verified over 15 months at 4°C.

## Technological Characteristics

Reagent system utilizing latex particles coated with anti-CRP antibodies. Principle: latex agglutination measured by absorbance change at 550 nm. Designed for use on Cobas Mira chemistry analyzer. Multistandard calibration (0, 1, 5, 10, 15, 20 mg/dl). Reportable range: 0.1-20.0 mg/dl.

## Regulatory Identification

A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.

## Predicate Devices

- quantex CRP plus (k904312)

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
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K960702
APR 19 1996

# SUMMARY OF SAFETY AND EFFECTIVENESS

## CRP-LATEX "SEIKEN" XR on the Cobas Mira Chemistry Analyzer

Below summarizes and compares the performance of CRP-LATEX "SEIKEN" XR 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. This summary shows that the two reagent systems are substantially equivalent.

## INTENDED USE

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

|  METHOD | CRP-LATEX "SEIKEN" XR | k904312
quantex CRP plus
BIOKIT USA, Inc.
113 Hartwell Avenue
Lexington, MA 02173  |
| --- | --- | --- |
|  Product Code | 600554 | 3000-2092  |
|  Min. Detectable Conc. | 0.1 mg/dl | 0.3 mg/dl  |
|  Precision (Between-run) | 1.03 mg/dl 1.94%
5.03 mg/dl 2.24%
9.99 mg/dl 1.58% | less than 10%  |
|  Linearity | 0.1 - 20.0 mg/dl | 0.3 - 10.0 mg/dl  |
|  Correlation | y = 0.005 + 1.126X
y = CRP-LATEX "SEIKEN" XR
x = quantex CRP plus
n = 122
r = 0.9976 |   |

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

* Are reagent systems for the quantitation of the concentration of CRP in human serum.
* Are based on the agglutination of CRP in serum with latex particles coated with anti-CRP.
* Employ the absorbance change observed as the basis for quantitation.
* Are intended for use with the Cobas Mira chemistry analyzer.

# The CRP-LATEX "SEIKEN" XR and the quantex CRP plus are different in that:

* The CRP-LATEX "SEIKEN" uses a multistandard calibration curve and the quantex CRP plus a single point calibrator as the basis for calculating the concentration of CRP.
* The minimal detectable concentration for the CRP-LATEX "SEIKEN" XR is 0.1 mg/dl; that for the quantex CRP plus is 0.3 mg/dl.
* The maximum quantifiable concentration for the CRP-LATEX "SEIKEN" XR is 20.0 mg/dl; that for the Biokit system is 10.0 mg/dl

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

|  CRP | CRP-LATEX "SEIKEN" XR | quantex CRP plus  |
| --- | --- | --- |
|  S.VOL (ul) | 4 | 3  |
|  REAGENT VOL (R1) (ul) | 150 | 350  |
|  START R1 VOL (R2) (ul) | 85 | 80  |
|  START R2 VOL (R2) (ul) | -- | 80  |
|  CALC.STEP | RATE | ENDPOINT  |
|  STD | MULTI | 1 POINT  |
|   | (0,1,5,10,15,20) |   |
|  UNIT | mg/dl | mg/dl  |
|  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 **CRP-LATEX "SEIKEN" XR Reagent System**. The protocols used for data generation are given below, and the results are attached.

## ACCURACY

One hundred and twenty two serum samples with values spanning the reportable range for the assay were obtained and tested in parallel using the CRP-LATEX "SEIKEN" XR and the quantex CRP 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 twelve calibrators, covering the reportable range of the assay, with three 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 CRP plus / CRP-LATEX "SEIKEN"

![img-0.jpeg](img-0.jpeg)

Correlation quantex CRP plus / CRP-LATEX "SEIKEN"

NUMBER OF CASES : 122
INTERCEPT (a) = 0.0054380
r = 0.9976

REGRESSION EQUATION : $y = a + bX$
SLOPE (b) = 1.1258245
r = 0.9952

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# CRP-LATEX "SEIKEN" XR

## PRECISION (WITHIN-RUN)

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

|  SAMPLE NO. | MEAN | SD | C.V. %  |
| --- | --- | --- | --- |
|  1 | 1.06 | 0.04 | 3.36  |
|  2 | 3.09 | 0.07 | 2.35  |
|  3 | 5.10 | 0.10 | 2.02  |
|  4 | 10.01 | 0.32 | 3.20  |
|  5 | 15.02 | 0.57 | 3.77  |

## PRECISION (BETWEEN-RUN)

|  DAY | mg/dl  |   |   |
| --- | --- | --- | --- |
|   |  Sample 1 | Sample 2 | Sample 3  |
|  1 | 1.04 | 4.85 | 10.14  |
|  2 | 1.05 | 5.02 | 9.69  |
|  3 | 1.05 | 5.14 | 10.16  |
|  4 | 1.01 | 5.03 | 9.82  |
|  5 | 1.06 | 4.96 | 9.99  |
|  6 | 1.02 | 5.14 | 9.85  |
|  7 | 1.03 | 5.13 | 10.02  |
|  8 | 1.02 | 5.11 | 10.08  |
|  9 | 1.05 | 4.85 | 9.99  |
|  10 | 1.00 | 5.09 | 10.15  |
|  Average | 1.03 | 5.03 | 9.99  |
|  SD | 0.02 | 0.11 | 0.16  |
|  C.V. % | 1.94 | 2.24 | 1.58  |

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LINEARITY

|  mq/dl | mq/dl  |   |   |   |
| --- | --- | --- | --- | --- |
|   |  Lot. 1 | Lot. 2 | Lot.3 | Average  |
|  0.50 | 0.57 | 0.54 | 0.42 | 0.51  |
|  1.00 | 1.06 | 1.10 | 1.03 | 1.06  |
|  2.00 | 2.06 | 2.10 | 2.11 | 2.09  |
|  4.00 | 3.91 | 3.87 | 3.97 | 3.92  |
|  6.00 | 5.71 | 5.76 | 5.75 | 5.74  |
|  8.00 | 7.94 | 7.79 | 7.95 | 7.89  |
|  10.00 | 9.76 | 9.78 | 9.87 | 9.80  |
|  12.00 | 11.58 | 11.25 | 11.75 | 11.53  |
|  14.00 | 13.64 | 13.86 | 13.68 | 13.73  |
|  16.00 | 15.86 | 15.65 | 15.93 | 15.81  |
|  18.00 | 17.87 | 17.80 | 18.06 | 17.91  |
|  20.00 | 19.76 | 19.76 | 19.62 | 19.71  |
|  A = | -0.007 | -0.009 | -0.010 | -0.009  |
|  B = | 0.985 | 0.981 | 0.989 | 0.985  |
|  r = | 0.9998 | 0.9996 | 0.9998 | 0.9998  |
|  y = A + B x  |   |   |   |   |

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STABILITY Stored at 4 °C.

|  MONTH | Lot. 1 (mq/dl) |   |   | Lot.2 (mq/dl)  |   |   |
| --- | --- | --- | --- | --- | --- | --- |
|   |  Sample 1 | Sample 2 | Sample 3 | Sample 1 | Sample 2 | Sample 3  |
|  0 | 1.07 | 5.21 | 10.31 | 1.08 | 4.93 | 9.72  |
|  3 | 1.07 | 4.83 | 10.02 | 0.96 | 5.17 | 10.59  |
|  6 | 0.99 | 5.33 | 10.30 | 0.99 | 5.04 | 10.06  |
|  12 | 0.93 | 5.10 | 9.98 | 1.03 | 4.94 | 9.90  |
|  15 | 1.02 | 5.16 | 10.45 | 1.05 | 5.05 | 9.77  |

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**Source:** [https://fda-staging.innolitics.com/device/K960702](https://fda-staging.innolitics.com/device/K960702)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

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