DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE

K043546 · Dade Behring, Inc. · CDT · Jan 18, 2005 · Clinical Chemistry

Device Facts

• Record ID: K043546
• Device Name: DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE
• Applicant: Dade Behring, Inc.
• Product Code: CDT · Clinical Chemistry
• Decision Date: Jan 18, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1705
• Device Class: Class 1

Intended Use

The Dimension® RxL Max™ with StreamLAB® Analytical Workeell and Sample Transfer Module is a discrete photometric chemistry analyzer for clinical use intended to duplicate 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.

Device Story

The Dimension® RxL Max™ is a discrete, random-access, microprocessor-controlled clinical chemistry system. The modified device integrates a StreamLAB® Analytical Workcell and Sample Transfer Module to automate specimen preparation. The system processes human body fluid samples, performing automated pipetting, filtrate preparation, heating, and color intensity measurement to quantify analytes and enzyme activities. It also supports high-sensitivity chromium-based heterogeneous immunoassays via an HM module. Used in clinical laboratory environments by trained personnel, the system provides quantitative results that assist healthcare providers in diagnosing and monitoring patient health. The automation components streamline workflow by managing sample transport and preparation prior to analysis on the chemistry system.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, operating principles, and performance characteristics identical to the predicate device.

Technological Characteristics

Discrete, random-access, microprocessor-controlled photometric chemistry analyzer. Includes integrated StreamLAB® Analytical Workcell and Sample Transfer Module for automated sample handling. Supports heterogeneous immunoassays via HM module. System is networked for laboratory automation. Sterilization and specific material standards are not detailed.

Indications for Use

Indicated for clinical use in laboratory settings to measure various analytes and enzyme activities in human body fluids via automated photometric analysis.

Regulatory Classification

Identification

A triglyceride test system is a device intended to measure triglyceride (neutral fat) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.

Predicate Devices

• Dimension RxL Max™ (K043546)

Submission Summary (Full Text)

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# JAN | 8 2005

Special 510(k): Device Modification

Dimension® RxL Max™ Clinical Chemistry System with StreamLAB® Analytical Workcell and Samle Transfer Module

### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS For Dimension® RxL Max™ Clinical Chemistry System with Automation System

### 1. Manufacturer and Contact Information:

| Manufacturer: | Dade Behring Inc.<br>101 Silvermine Road.<br>Brookfield, CT 06904 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Information: | Stanley P. Gorak.<br>Quality Systems and Compliance Manager<br>Dade Behring, Inc.<br>500 GBC Drive, M/S 514<br>P.O. Box 6101<br>Newark, DE 19714-6101<br>Tel: [phone]<br>Fax: [phone] |

### Date Summary Prepared: 2.

December 16, 2004

#### 3. Device Trade Namel Common Name:

Dimension® RxL Max™ / StreamLAB® Analytical Workcell/ Sample Transfer Module

#### Device Classification Name: 4.

Analyzer, chemistry (photometric, discrete), for clinical use has been classified as Class I, JJE by the Clinical Chemistry and Clinical Toxicology Devices Panel, (21 CFR 862.2160). No performance standards have been established under Section 514 of the Food, Drug, and Cosmetic Act.

#### ક. Intended Use:

The Dimension RXL Max™ clinical chemistry system with automation system is a discrete, randomaccess, microprocessor-controlled, integrated instrument/chemistry system that measures a variety of analytes, including enzyme activities, in body fluids. It can also process high-sensitivity chromiumbased heterogeneous immunoassays with its HM module.

### Device Description: 6.

The modified device includes the connection of a StreamLAB® Analytical Workcell and Sample Transfer Module. These are used to prepare specimens from the human body for testing on the Dimension® RxL Max™ system.

### 7. Substantial Equivalence

The modified device has the same operating principles, design, manufacturing materials, method of manufacture, assay performance characteristics and intended use as the predicate device. In conclusion the modified Dimension® RxL Max ™ with automation system is substantially equivalent to the predicate Dimension RxL Max™ .

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Stanley P. Gorak, Jr. Quality Systems and Compliance Manager Dade Behring Inc. 500 GBC Drive, M/S 514 P.O. Box 6101 Newark, DE 19714-6101

Re: k043546 Trade/Device Name: Dimension® RxL Max™ with StreamLAB® Analytical Workcell and Sample Transfer Module Regulation Number: 21 CFR 862.1770 Regulation Name: Urea nitrogen test system Regulatory Class: Class II Product Code: CDQ, CDT, CEC, CEK, CEM, CHO, CFI, CFQ, CFR, CGS, CGX, CGZ, CHH, CHI, CIC, CIG, CIT, CJF. CIW, CKA, CKE, C/W, DBI. DCF, DCN, DDG, DDR, DHA, DIH, DIO, DIP, DIS, DIG, DIR. DKI, DKZ, DI.Z, DMI, JFJ, JFL, JGJ, JHC, JHM, JHT, JIHY, JIF, JIH, JJE, JLW, JMG, JMO, JQB, JXM, KHP, KHQ, KHS, KLB, KLI, KLR, KLS, KLT, KXT, LAN, LAR, LCD, LCM, LCP, LDJ, LDP, LEG, LEH, LFM, MKW, MMI, MRR, NBC Dated: December 21, 2004 Received: December 23, 2004

JAN 1 8 2005

Dear Mr. Gorak:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (sec above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Txisting major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act many Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Cornelia B. Rooks

Cornelia B. Rooks, MA Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE STATEMENT

## 510(k) Number (If Known):

### Device(s) Name(s):

Dimension@ RxL Max™ with StreamLAB® Analytical Workeell and Sample Transfer Module

### Indications for Use:

The Dimension® RxL Max™ with StreamLAB® Analytical Workeell and Sample Transfer Module is a discrete photometric chemistry analyzer for clinical use intended to duplicate 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.

**Prescription Use**
(Part 21 CFR 801 Subpart D)
✓

and/or

Over-the-counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Carol Benson
Division Sign-Off

Office of In Vitro Diagnostic
Device Evaluation and Safety

5104: K043546

Dade Behring, Inc.