STA SATELLITE AUTOMATED MULTI-PARAMETER ANALYZER

K082248 · Diagnostica Stago, Inc. · JPA · Dec 12, 2008 · Hematology

Device Facts

• Record ID: K082248
• Device Name: STA SATELLITE AUTOMATED MULTI-PARAMETER ANALYZER
• Applicant: Diagnostica Stago, Inc.
• Product Code: JPA · Hematology
• Decision Date: Dec 12, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Intended Use

The STA Satellite™ Automated Multi-Parametric AnalyzerSatellite® Automated Multi-Parametric Analyzer is a fully automatic clinical instrument indicated and intended for the performance of tests on human plasmas, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.

Device Story

STA Satellite™ is a fully automated bench-top clinical analyzer for coagulation testing. Input: human plasma samples loaded into cuvettes via automated needle aspiration. Operation: system uses photometric and chronometric detection; photometric method measures absorbance of monochromatic light through cuvette; chronometric method measures oscillation amplitude of a metal ball within the cuvette, where amplitude decrease indicates coagulation. Output: automated analysis and reporting of coagulation test results. Used in clinical laboratory settings; operated by laboratory personnel. Healthcare providers use results to diagnose coagulation abnormalities or monitor anticoagulant therapy (e.g., Coumadin, UFH, LMWH). Benefits: provides standardized, automated, and efficient coagulation assessment compared to manual methods.

Clinical Evidence

Bench testing only. Validation study conducted at one internal and two external sites comparing STA Satellite to STA-R predicate. Samples analyzed in duplicate. Statistical analysis included mean, standard deviation, 95% confidence intervals, and correlation. Results demonstrated correlation within acceptance criteria for all assays; no significant difference between instruments or sites.

Technological Characteristics

Fully automatic bench-top system. Sensing principles: chronometric (viscosity-based oscillation amplitude) and photometric (optical density). Energy source: electrical. Connectivity: central processing unit for data management and reporting. Reagent management via barcode or manual entry. Software-controlled automated analysis.

Indications for Use

Indicated for use on human plasma samples to aid in the diagnosis of coagulation abnormalities or monitoring of anticoagulant therapy. Intended for clinical laboratory use.

Regulatory Classification

Identification

A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.

Special Controls

*Classification.* Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

Predicate Devices

• STA-R® Automated Multi-Parametric Analyzer (K983460)
• AMAX Destiny Coagulation Analyzer (K021162)

Submission Summary (Full Text)

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## Attachment - 6

## 510(k) SUMMARY

DEC 1 2 2008

# Diagnost

## Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared:

Umberto V. Parrotta Diagnostica Stago, Inc. Five Century Drive Parsippany, New Jersey 07054

Phone: (973) -631-1200, x-2044 Facsimile: (973) -695-0095

Contact Person: Umberto V. Parrotta

Date Prepared: August 06, 2008

#### Name of Modified Device and Name/Address of Sponsor:

STA Satellite®

Diagnostica Stago, Inc. Five Century Drive Parsippany, New Jersey 07054

#### Common or Usual Name:

- IVD Coagulation Device/Instrument. ●
- . Automated and Semi-Automated Hematology Device.
- Multi-Parametric Analyzer ●

#### Classification Name:

System, Multipurpose for In Vitro Coagulation Studies

#### Predicate Devices:

- Diagnostica Stago SAS' STA-R® Automated Multi-Parametric Analyzer . (K983460).
- Sigma Diagnostic Inc.'s AMAX Destiny Coagulation Analyzer (K021162). .

File: DSI-Satellite-Attachment-06v4-510(k)Summary.doc

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CONFIDENTIAL

Attachment - 6

## 510(k) SUMMARY

## Predicate Device Manufacturer:

Diagnostica Stago SAS

#### Purpose of the Special 510(k) notice:

The STA Satellite® is a modification to the company's own legally marketed device, STA-R®.

#### Indication/Intended Use:

The STA Satellite™ Automated Multi-Parametric AnalyzerSatellite® Automated Multi-Parametric Analyzer is a fully automatic clinical instrument indicated and intended for the performance of tests on human plasmas, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.

#### Technological Characteristics:

The STA Satellite® Automated Multi-Parametric Analyzer is designed as a fully automatic bench-top system. Samples and test reagents are loaded into the instrument where sample handling, reagent delivery, analysis, and reporting of results are performed automatically. A central processing unit controls instrument functions such as, management of patient results, quality control, system supervision, support for instrument maintenance, and work load optimization. The STA Satellite® is the bench-top version of the company's STA-R®, legally marketed predicate device.

The instrument utilizes Diagnostica Stago reagents in addition to open adaptation of other currently available reagents. Barcoding of test reagents, calibrators, and controls facilitate their use on the system and permits reagent management simple. Manual entry of reagent information enables the use of non-barcoded reagents.

The instrument performs multiple test methodologies in random access as selected by the user. These include clotting time or clot-based tests (i.e. Chronometricchronometric) measurements and photometric assays (at specific wave lengths) on plasma samples. The principle of the chronometric method consists in measuring the variation of the oscillation amplitude of the ball (in the cuvette). A decrease in oscillation amplitude corresponds to an increase in the viscosity of the media (i.e. ., coagulation). The principle of the photometric measurements on the instrument is based on measured absorbance (also referred

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CONFIDENTIAL

## Attachment - 6

## 510(k) SUMMARY

to as Optical Density, or OD) of monochromatic light of predetermined wavelength passing through the cuvette as a (clotting) reaction takes place.

### Performance Data:

Comparison of the device and predicate device performance characteristics was conducted during the performance validation study. Validation of the STA -Satellite® with the STA-R® predicate device was performed at an internal site and two external sites.

Test samples were analyzed in duplicate on the STA -Satellite and the STA-R. Results were analyzed by standard statistical methods (mean, standard deviation, 95% confidence intervals, correlation between instruments and comparison to acceptance criteria).

Correlation data between the STA -Satellite and the STA-R were within the acceptance criteria for all assays and all sites (see Table below for assays performed). There was no significant difference or clinically significant difference between the results from the instruments between the sites and instruments.

In addition, the STA Satellite® is CE Marked and has been in commerce in France since September 2004. There have been no adverse performance-related events or analogous complaints resulting in recalls with regards to its design during this time that would raise questions of safety and effectiveness.

In conclusion, performance validation study comparison results between the STA Satellite® and the STA-R device instrument and predicate device indicate statistically similar results. , Analysis of which demonstrates substantial equivalence.

#### Substantial Equivalence:

The STA Satellite® has the same intended use and similar indications, principles of operation, and technological characteristics as the STA-R® and the AMAX predicate devices. The differences in the external architecture, software, and chronometric viscosity detection do not raise any new questions of safety or effectiveness. Performance data and risk assessment demonstrate that the STA Satellite® is as safe and effective as STA-R@the predicate devices. Thus, the STA Satellite® is substantially equivalent to its predicate devices.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Diagnostica Stago, Inc. C/o Umberto V. Parrotta Five Century Drive Parsippany, New Jersey 07054

## DEC 1 2 2008

Re: k082248

Trade/Device Name: STA Satellite® Automated Multi-Parametric Analyzer Regulation Number: 21 CFR 864.5425 Regulation Name: Multipurpose System for In Vitro Coagulation Studies Regulatory Class: Class II Product Code: JPA Dated: October 03, 2008 Received: October 06, 2008

#### Dear Mr. Parrotta:

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. Isting 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 (PMA), it may be subject to such additional controls. Existing 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 or any 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 (OS) regulation (21 CFR Part 820). 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

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Page 2 - Mr. Parrotta

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), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at 240-276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

Marian Chan, PhD

Acting Division Director

Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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CONFIDENTIAL Attachment - 2A

## Indications for Use Form

510(k) Number (if known): KO822248

Device Name:

Satellite™ Automated Multi-Parametric Analyzer

Indications for Use:

The Satellite™ is a fully automatic clinical instrument designed for the performance of tests on human plasmas, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off

Office of In Vitro Diagnostic Device

Office of In Vitro Diamostic Device Evaluation and Safely

Prescription Use (Per 21 C.F.R. 801.109)

510(k) OR K082246 Over-The-Counter Use

(Optional Format 1-2-96)

File: DSI-Satellite-Attachment-2A-IndicationsForUseStatementForm.doc