ELECSYS 2010 ANALYZER

K961481 · Boehringer Mannheim Corp. · JJE · Jun 14, 1996 · Clinical Chemistry

Device Facts

• Record ID: K961481
• Device Name: ELECSYS 2010 ANALYZER
• Applicant: Boehringer Mannheim Corp.
• Product Code: JJE · Clinical Chemistry
• Decision Date: Jun 14, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.2160
• Device Class: Class 1

Intended Use

The Elecsys 2010 analyzer is intended to be used for the in vitro quantitative and qualitative analysis of analytes in body fluids.

Device Story

Elecsys 2010 analyzer is a fully automated, random access, computer-controlled system for clinical laboratory use. It processes human serum and plasma samples to perform quantitative and qualitative analyte determinations. The device utilizes an electrochemiluminescence (ECL) immunoassay method, differing from the predicate's enzyme-linked immunosorbent assay (ELISA). Input samples are processed via automated liquid handling, including liquid level and clot detection. The system features 30 sample positions and 15 reagent positions. The analyzer provides results to healthcare providers to assist in clinical decision-making regarding patient diagnosis and monitoring. It interfaces with laboratory information systems via an RS232C bidirectional connection.

Clinical Evidence

Bench testing only. Performance evaluated via comparative analysis against the ES300 predicate. Regression analysis performed for T4, FT4, TSH, T-Uptake, hCG, and Troponin-T. Results showed strong correlation (r = 0.908 to 0.991) and linear regression slopes ranging from 0.954 to 1.35. Sample sizes for specific analytes ranged from n=54 to n=319.

Technological Characteristics

Automated immunoassay analyzer; electrochemiluminescence (ECL) detection principle; flow-through detection cell; RS232C bidirectional connectivity; computer-controlled; 30 sample positions; 15 reagent positions; sample volume 10-50μL.

Indications for Use

Indicated for in vitro quantitative and qualitative determination of analytes in human serum and plasma.

Regulatory Classification

Identification

A discrete photometric chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes. Different models of the device incorporate various instrumentation such as micro analysis apparatus, double beam, single, or dual channel photometers, and bichromatic 2-wavelength photometers. Some models of the device may include reagent-containing components that may also serve as reaction units.

Predicate Devices

• Boehringer Mannheim ES300 Immunoassay system

Submission Summary (Full Text)

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JUN 14 1996
K961481

# 510(k) Summary

## Introduction

According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.

## 1) Submitter name, address, contact

Boehringer Mannheim Corporation
9115 Hague Rd.
Indianapolis, IN 46250
[phone]

Contact Person: John D. Stevens
Date Prepared: April 17, 1996

## 2) Device name

Proprietary name: Elecsys 2010® analyzer
Common name: immunoassay analyzer
Classification name: Discrete photometric analyzer for clinical use

## 3) Predicate device

We claim substantial equivalence to the Boehringer Mannheim ES300 Immunoassay system.

## 4) Device Description

The Elecsys 2010 analyzer is a fully automated, random access, computer controlled analytical system for quantitative and qualitative determinations of analytes in body fluids

## 5) Intended use

The Elecsys 2010 analyzer is intended to be used for the in vitro quantitative and qualitative analysis of analytes in body fluids.

Continued on next page

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# 510(k) Summary Elecsys® 2010 Analyzer, Continued

## 6) Comparison to predicate device

The Boehringer Mannheim Elecsys 2010 analyzer is substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed ES300 Immunoassay analyzer.

The following table compares the Elecsys 2010 with the predicate device. Specific data on the performance of the system have been incorporated into the draft labeling in attachment 5. Labeling for the predicate device is provided in attachment 6.

### Similarities:

| Feature | Elecsys 2010 Analyzer | ES300 Analyzer |
| --- | --- | --- |
| Intended use | Intended for the in vitro quantitative/qualitative determination of analytes in body fluids | Same |
| Number of reagents | Up to 2 | Same |
| Sample detection | Liquid level detection and clot detection | Same |
| Sample type | Serum and plasma | Same |
| Host interface | RS232C bidirectional | Same |

### Differences:

| Feature | Elecsys 2010 analyzer | ES300 analyzer |
| --- | --- | --- |
| Operating principle | Electrochemiluminescence immunoassay method type | Enzyme-linked immunosorbent assay method type |
| Detection system | Flow through electrochemiluminescence detection cell | Flow through cuvette with halogen lamp light source |
| Sample positions | 30 positions for samples, controls and calibrators | 150 positions for samples, controls and calibrators |
| Sample volume / test | 10 to 50μL | 5 to 200 μL |
| Reagent positions | 15 reagent positions
2 diluent/reagent positions
1 BlankCell position | 12 reagent positions
1 cleaning solution
2 universal substrate |

Continued on next page

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510(k) Summary, Elecsys 2010® Analyzer Continued

6) Comparison to predicate device, (cont.)

Performance Characteristics:

| Feature | Elecsys 2010 vs. ES300 Least Squares Regression |
| --- | --- |
| Method | Y = 1.02x +0.85 |
| Comparison | SEE = 5.39 |
| T4 | r = 0.947 |
| Method | Y = 0.954X + 0.18 |
| Comparison | SEE + 1.11 |
| FT4 | r + 0.981 |
| Method | Y = 1.09X + 0.14 |
| Comparison | SEE = 0.798 |
| TSH | r = 0.991; n = 132 |
| Method | Y = 0.99X - 0.03 |
| Comparison | SEE = 0.04 |
| T-Uptake | r = 0.908; n = 319 |
| Method | Y = 1.35X - 9.21 |
| Comparison | SEE = 17.50 |
| hCG | r = 0.989; n = 64 |
| Method | Y = -0.033 + 0.996 |
| Comparison | SEE = 0.547 |
| Troponin-T | r = 0.969; n = 54 |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration
2098 Gaither Road
Rockville MD 20850

# MAY 17 2000

Ms. Kay Taylor
Regulatory Affairs, Laboratory Systems
Roche Diagnostics Corporation
9115 Hague Road
P.O. Box 50457
Indianapolis, Indiana 46250-0457

Re: K961481
Trade Name: Elecsys 2010 Analyzer
Regulatory Class: II
Product Code: CDX, CEC, DHA, JJE, JLW, KHQ, MMI
Dated: May 29, 1996
Received: May 30, 1996

Dear Ms. Taylor:

This letter corrects our substantially equivalent letter of June 14, 1996, regarding the Elecsys 2010 Analyzer. The Elecsys 2010, associated reagents, and subsequent models within the Elecsys Family of analyzers referenced in K961481 were only classified as a class I device. Elecsys analyzers with their associated reagents are considered combination devices and carry the highest classification as stated in Blue Book memo #K86-3 "When such a device is found to be SE, it combines devices from different classes and is classified in the highest of the predicate device classifications."

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895.

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Page 2 – Ms. Taylor

A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the *Federal Register*. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for *in vitro* diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, “Misbranding by reference to premarket notification” (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven I. Gutman, M.D., M.B.A.
Director
Division of Clinical Laboratory Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K0101481

Device Name: Elecsys® 2010 Analyzer

Indications for Use:

The Elecsys 2010 analyzer is an immunoassay analyzer intended for the in vitro quantitative and qualitative determination of analytes in human serum and plasma


(Division Sign-Off)

Division of Clinical Laboratory Devices

510(k) Number K0101481

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

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