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

Indications for 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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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY INSTRUMENT ONLY TEMPLATE

A. 510(k) Number:
K082248

B. Purpose for Submission:
Clearance of a modified cleared device

C. Manufacturer and Instrument Name:
Diagnostica Stago STA Satellite™ Automated Multi-Parametric Analyzer

D. Type of Test or Tests Performed:
Coagulation

E. System Descriptions:

1. Device Description:
The DSI STA Satellite™ is a fully automated bench-top system. Samples and test reagents are loaded into the instrument where sample handling, reagent delivery, analysis, and reporting or results are performed automatically.

The STA Satellite™ System consists of a cuvette, which holds patient sample and any needed reagent; a metal ball located in the cuvette that oscillates to measure coagulation; a needle that aspirates and dispenses sample and reagent into the cuvette; a camera to measure coagulation by chronometric method; a light source and sensor to transmit light through the cuvette and subsequently measure the light absorbed; and application software.

2. Principles of Operation:
The STA Satellite™ system uses the well established photometric and chronometric methods of detection. The photometric measurement is based on measured absorbance of monochromatic light passing through the cuvette as clotting takes place. The chronometric method consists of measuring variation of the oscillation amplitude of the metal ball in the sample cuvette. A decrease in amplitude corresponds to coagulation.

3. Modes of Operation:

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Automated, Random access, Stat

4. Specimen Identification:
Specimens are identified by barcode and rack position.

5. Specimen Sampling and Handling:
Centrifuged, open tube samples are loaded onto a sample carousel. Tubes are sampled by the instrument and loaded into the appropriate cuvette for assaying.

6. Calibration:
The STA Satellite™ automatically requires calibration for each lot of reagents used. The calibration can be automatically validated if calibration controls are used (user must define two control plasmas) or manually validated if control values are outside the acceptable range.

7. Quality Control:
QC for each test is mandatory. User can use up to three control plasmas, one of which must be defined. Control values outside a pre-determined range are flagged by the system.

8. Software:
FDA has reviewed applicant’s Hazard Analysis and Software Development processes for this line of product types:
Yes ☐ X or No ☐

F. Regulatory Information:

1. Regulation section:
21 CFR 864.5425

2. Classification:
Class II

3. Product code:
JPA

4. Panel:

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81 Hematology

G. Intended Use:

1. Indication(s) for Use:

The STA Satellite™ Automate 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.

2. Special Conditions for Use Statement(s):

H. Substantial Equivalence Information:

1. Predicate Device Name(s) and 510(k) numbers:

Diagnostica Stago STA-R ® Automated Multi-Parametric Analyzer (K983460)

2. Comparison with Predicate Device:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | An automated clinical instrument for the performance of tests on human plasmas, the results of which aid in the diagnosis of coagulation abnormalities or in the monitoring anticoagulant therapy. | same |
| Principle of Operation | Photometric and chronometric | same |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Technological characteristics | Chronometric detection method of a photo-optical detection | Chronometric detection of a mechanical detection system |
| Architecture | Bench top | Floor model |

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I. Special Control/Guidance Document Referenced (if applicable):

J. Performance Characteristics:

1. Analytical Performance:

a. Accuracy:

Data comparing the STA Satellite™ was collected at 3 sites- 2 foreign sites (one being the manufactures site) and 1 US site. Samples were obtained from liver disease patients, patients on Coumadin therapy, unfractionated heparin (UFH) and low molecular weight heparin (LMWH) therapy and normal outpatients.

Data was presented by site and pooled. Initial testing at the US site did not meet acceptance criteria. Routine preventive maintenance was performed and testing repeated which produced acceptable results.


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Instrument comparison: APTT, seconds

Instrument comparison : mean Fibrinogen, mg/dl

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Instrument Comparison: AT, mean % of normal

Instrument Comparison: UFH, IU/ml

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Instrument Comparison: LMWH, IU/ml

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# b. Precision/Reproducibility:

Within-run precision was evaluated on 21 single tests using the following controls: STA® Coag N + ABN (PT< APTT> Fibrinogen), STA® System Control P (AT III), STA® Heparin control (UFH), STA® Quality LMWH (LMWH) and STA® Liatest Control (D-Dimer). Precision was assessed on three instruments.

Statistical Summary of the STA-Satellite® Intra-run Precision

| | Mean | Std Dev | C.V. | 95% CI |
| --- | --- | --- | --- | --- |
| PT Normal | 13.71 | 0.14 | 1.06 | 13.28 – 14.15 |
| PT Abnormal | 21.46 | 0.3 | 1.40 | 20.55 – 22.36 |
| APTT Normal | 35.25 | 0.16 | 0.45 | 34.78 – 35.72 |
| APTT Abnormal | 54.39 | 0.41 | 0.75 | 53.16 – 55.61 |

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| Fibrinogen Normal | 326.86 | 11.17 | 3.42 | 293.36 – 360.35 |
| --- | --- | --- | --- | --- |
| Fibrinogen Abnormal | 106.06 | 4.71 | 4.44 | 91.92 – 120.21 |
| AT Normal | 97.56 | 1.67 | 1.72 | 92.54 – 102.57 |
| AT Abnormal | 43.49 | 0.72 | 1.65 | 41.35 – 45.64 |
| UFH Normal | 0.28 | 0.01 | 4.95 | 0.24 – 0.32 |
| UFH Abnormal | 0.57 | 0.01 | 2.23 | 0.53 – 0.60 |
| LMWH Normal | 0.74 | 0.03 | 3.58 | 0.66 – 0.82 |
| LMWH Abnormal | 1.45 | 0.06 | 4.15 | 1.27 – 1.63 |
| D-Dimer Normal | .24 | 0.04 | 17.36 | 0.11 – 0.36 |
| D-Dimer Abnormal | 2.08 | 0.05 | 2.27 | 1.93 – 2.22 |

Inter-run (day-to-day) precision was evaluated on $n \geq 20$ days with the results of the daily controls: STA® Coag N + ABN (PT< APTT> Fibrinogen), STA® System Control P (AT III), STA® Heparin control (UFH), STA® Quality LMWH (LMWH) and STA® Liatest Control (D-Dimer).

| | Mean | Std Dev | C.V. | 95% CI |
| --- | --- | --- | --- | --- |
| PT Normal | 13.93 | 0.20 | 1.45 | 13.32 – 14.53 |
| PT Abnormal | 20.99 | 0.25 | 1.20 | 20.23 – 21.74 |
| APTT Normal | 33.92 | 0.39 | 1.15 | 32.75 – 35.09 |
| APTT Abnormal | 55.25 | 1.16 | 2.11 | 51.76 – 58.75 |
| Fibrinogen Normal | 337.00 | 9.98 | 2.96 | 307.06 – 366.94 |
| Fibrinogen Abnormal | 115.07 | 3.05 | 2.65 | 105.92 - 124.22 |
| AT Normal | 109.43 | 2.85 | 2.60 | 100.89 – 117.98 |
| AT Abnormal | 44.70 | 2.74 | 6.14 | 36.47 – 52.93 |
| UFH Normal | 0.29 | 0.01 | 4.72 | 0.25 – 0.33 |

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| UFH Abnormal | 0.58 | 0.02 | 3.00 | 0.53 – 0.63 |
| --- | --- | --- | --- | --- |
| LMWH Normal | 0.75 | 0.02 | 3.26 | 0.68 – 0.82 |
| LMWH Abnormal | 1.45 | 0.06 | 4.18 | 1.27 – 1.63 |

c. Linearity:

A Fibrinogen reportable range of 150-900 mg/dl was demonstrated by testing 13 samples containing fibrinogen from 140 to 1040 mg/dl, on two STA Satellite® analyzers. Percent recovery (STA Satellite value/expected value x 100%) varied from 94 – 105 % across the range of values.

An ATIII reportable range of up to 140% for the photometric ATIII assay was demonstrated by testing 13 samples containing 0 to 153% ATIII, on two STA Satellite® analyzers. Percent recovery (STA Satellite value/expected value x 100%) varied from 84 – 105 % across the range of values.

Unfractionated Heparin (UFH) linearity of up to 0.70 anti-Xa IU/ml for the UFH assay was demonstrated by testing 13 samples containing 0 to 0.75 IU/ml UFH, on two STA Satellite® analyzers. Percent recovery (STA Satellite value/expected value x 100%) varied from 89 to 110%.

A D-Dimer reportable range of 0.0 -4.0 µg/ml was demonstrated by testing 14 samples containing from 0 -4 µg/ml of d-dimer, on two STA Satellite® analyzers. Percent recovery (STA Satellite value/expected value x 100%) varied from 93 – 105 % across the range of values.

Low Molecular Weight Heparin (LMWH) linearity of up to 2.0 anti-Xa IU/ml was demonstrated by testing samples containing 0 to 2.40 anti-Xa IU/ml of LMWH on two STA Satellite® analyzers. Percent recovery (STA Satellite value/expected value x 100%) varied from 92 to 103%.

d. Carryover:

Sample to sample carry-over was evaluated on three STA Satellite™ analyzers. A normal human plasma pool was prepared and divided into two portions. 10 IU of UFH was added to one portion which caused the APTT value to be >100 secs. The heparinized pool was tested five times followed by the normal pool. This cycle was repeated five times. The APTT values of the normal pool remained unaffected by the heparinized pool, demonstrating the lack of sample-to-sample carryover.

e. Interfering Substances:

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N/A

2. Other Supportive Instrument Performance Data Not Covered Above:

K. Proposed Labeling:

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

L. Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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