FISHER DIAGNOSTICS THROMBOSCREEN 1000; PACIFIC HEMOSTASIS FIBRINOGEN REAGENT PLUS KAOLIN

K023362 · Fisher Diagnostics · GKP · Dec 9, 2002 · Hematology

Device Facts

• Record ID: K023362
• Device Name: FISHER DIAGNOSTICS THROMBOSCREEN 1000; PACIFIC HEMOSTASIS FIBRINOGEN REAGENT PLUS KAOLIN
• Applicant: Fisher Diagnostics
• Product Code: GKP · Hematology
• Decision Date: Dec 9, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5400
• Device Class: Class 2

Indications for Use

The Fisher Diagnostics ThromboScreen® 1000 is a photo-optical instrument used for the performance of in-vitro diagnostic coagulation testing of citrated plasma specimens in the clinical laboratory. Coagulation testing capabilities of the device include routine clotting tests such as Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT), and Fibrinogen. The Pacific Hemostasis® Fibrinogen Reagent plus Kaolin is intended to be used on the Fisher Diagnostics ThromboScreen® 1000 Coagulation Instrument for the quantitative determination of fibrinogen in plasma.

Device Story

ThromboScreen® 1000 (TS1000) is an automated photo-optical coagulation instrument for clinical laboratories. It accepts citrated plasma specimens; uses a 660 nm LED light source to measure light transmission changes as plasma clots in a temperature-regulated (36.5-37.5°C) incubator block. The device performs routine clotting tests (PT, APTT, Fibrinogen). Pacific Hemostasis® Fibrinogen Reagent plus Kaolin is used to enhance clot visibility in the stirred reaction cell. Operators (lab technicians) load samples and reagents; the instrument automates the timing and recording of clotting procedures. Output is a quantitative measurement of clotting time or fibrinogen concentration, which assists clinicians in assessing coagulation status and managing patients on anticoagulants like Coumadin or Heparin.

Clinical Evidence

Bench testing only. Method comparison studies performed at three sites (in-house and two external) using 60-100 samples per test type (PT, APTT, Fibrinogen) compared TS1000 to predicate devices. Correlation coefficients (r) ranged from 0.94 to 0.99. Precision studies (within-run and between-run) evaluated %CV across various coagulation levels; TS1000 demonstrated performance comparable to predicate devices. No clinical prospective/retrospective trials on human subjects were required.

Technological Characteristics

Photo-optical coagulation instrument. Features 660 nm LED light source, temperature-regulated incubator block (36.5-37.5°C) with six measuring and six reagent positions. Automated pipetting and stirring mechanism. Reagent: Fibrinogen Reagent plus Kaolin. Connectivity: Standalone clinical laboratory instrument.

Indications for Use

Indicated for in-vitro diagnostic coagulation testing (PT, APTT, Fibrinogen) of citrated plasma specimens in clinical laboratory settings. Used for quantitative determination of fibrinogen in plasma.

Regulatory Classification

Identification

A coagulation instrument is an automated or semiautomated device used to determine the onset of clot formation for in vitro coagulation studies.

Special Controls

*Classification.* Class II (special controls). A fibrometer or coagulation timer intended for use with a coagulation instrument 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

• MLA 900C (K884863)
• MLA 1600C (K931206)
• Fibrinogen Reagent (K781880)

Submission Summary (Full Text)

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| 11.0 | PREMARKET NOTIFICATION 510(K) SUMMARY |
|------|---------------------------------------|
|------|---------------------------------------|

| | DEC 09 2002 |
|----------------------|----------------------------------------|
| Applicant: | Jerald Steiner |
| | Fisher Diagnostics |
| | 8365 Valley Pike |
| | Middletown, Virginia 22645 |
| | Telephone: [phone] |
| | Fax: [phone] |
| Contact: | Jerald Steiner |
| | Telephone: [phone] |
| | Fax: [phone] |
| Date: | 10/4/02 |
| Trade Name: | Fisher Diagnostics ThromboScreen® 1000 |
| | Pacific Hemostasis® Fibrinogen Reagent |
| | plus Kaolin |
| Common Name: | Automatic Coagulation Instrument |
| | Fibrinogen Reagent |
| Classification Name: | Coagulation Instrument |
| | 21 CFR 864.5400 |
| | Fibrinogen Test |
| | 21 CFR 864.7340 |
| Equivalent Devices: | MLA 900C (K884863) |
| | MLA 1600C (K931206) |
| | Fibrinogen Reagent (K781880) |

| | K023362 |
|--|---------|
|--|---------|

#### Description of the Devices

The ThromboScreen® 1000 (TS1000) is a photo-optical instrument used for the performance of in-vitro diagnostic clotting procedures in the clinical laboratory. The instrument utilizes photo-optical principles to measure and record the time required for subject plasma specimens to clot. The TS1000 light source is provided by a 660 nm LED. The incubator block is temperature regulated to 36.5 - 37.5°C and contains six measuring positions and six reagent positions. A detailed description of the device, including an explanation of how it functions, is described in the TS 1000 Operator's Manual, Section l , Introduction.

The Pacific Hemostasis® Fibrinogen Reagent plus Kaolin is identical to the Pacific Hemostasis® Thrombin for Fibrinogen Kit, except that the thrombin is reconstituted with water containing kaolin rather than water. Kaolin is added to increase the visibility of the clot in the stirred reaction cell.

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### Intended Use of the Devices

The Fisher Diagnostics ThromboScreen® 1000 is a photo-optical instrument used for the performance of in-vitro diagnostic coagulation testing of citrated plasma specimens in the clinical laboratory. Coagulation testing capabilities of the device include routine clotting tests such as Prothrombin Time (PT). Activated Partial Thromboplastin Time (APTT), and Fibrinogen.

The Pacific Hemostasis® Fibrinogen Reagent plus Kaolin is intended to be used on the Fisher Diagnostics ThromboScreen® 1000 Coagulation Instrument for the quantitative determination of fibrinogen in plasma.

#### Summary of Substantial Equivalence Comparisons

The ThromboScreen® 1000 (TS1000) was compared to the MLA 900C and the MLA 1600C (K884863 & K931206, respectively). All three instruments have a similar intended use: for in-vitro diagnostic coagulation testing in the clinical laboratory. Further, the proposed device and the predicate devices have the same measurement system for clotting assays: photo-optical clot detection systems.

The TS1000 is an automated coagulation instrument. In contrast, the MLA 900C is semiautomated and the MLA 1600C is a fully-automated instrument. The MLA 900C requires manual save an automatic pipetting system, which adds both sample and test reagent. The light source for the MLA instruments is a Halogen lamp and the wavelength is set at 550 nm (for clotting assays). In contrast, the TS1000 utilizes an LED optic at 660 nm. Although differences in light source and wavelength exist, all instruments have been optimized for their light source/filter combinations. The performance data generated support this statement (Tables 1-3).

Comparison testing was performed in-house and at two external testing laboratories using Pacific Hemostasis (PH) brand reagents. As part of this submission, kaolin was added to the fibrinogen reagent used on the TS1000 to optimize detection. Specimens were evaluated from apparently healthy individuals and from subjects with different pathological conditions which are expected to affect the results for a particular assay. Table 1 summarizes the results of the comparison studies between the proposed and the predicate devices.

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| Test<br>(Reagent, Unit) | | Site & Sample # | Correlation<br>Coefficient, r | Regression<br>Equation |
|----------------------------------------------------------------------------|-----------------------------|---------------------------------------------|-------------------------------|---------------------------------------------------------------|
| Prothrombin Time<br>(PT)<br>(Thromboplastin DS,<br>seconds) | General Clinical<br>Samples | Site 1 - 60<br>Site 2 - 60<br>Site 3 - 60 | 0.98<br>0.99<br>0.97 | y = 1.475x - 6.66<br>y = 1.045x - 1.26<br>y = 1.126x - 2.51 |
| Prothrombin Time<br>(Thromboplastin DS,<br>INR) | | Site 1<br>Site 2<br>Site 3 | 0.99<br>0.98<br>0.98 | y = 1.437x - 0.41<br>y = 1.037x - 0.11<br>y = 1.031x - 0.02 |
| Prothrombin Time<br>(PT)<br>(Thromboplastin DS,<br>seconds) | Coumadin<br>Samples | Site 1 - 100<br>Site 2 - 100<br>Site 3 - 92 | 0.96<br>0.97<br>0.96 | y = 1.142x - 1.16<br>y = 1.142x - 1.27<br>y = 0.924x + 6.04 |
| Prothrombin Time<br>(Thromboplastin DS,<br>INR) | | Site 1<br>Site 2<br>Site 3 | 0.96<br>0.97<br>0.96 | y = 1.066x + 0.14<br>y = 0.984x + 0.13<br>y = 0.786x + 0.68 |
| Activated Partial<br>Thromboplastin Time*<br>(APTT-LS reagent,<br>seconds) | General Clinical<br>Samples | Site 1 - 58<br>Site 2 - 60<br>Site 3 - 60 | 0.99<br>0.98<br>0.98 | y = 1.189x - 2.99<br>y = 1.205x - 4.24<br>y = 1.161x - 2.93 |
| | Heparin Samples | Site 1 - 60<br>Site 2 - 60<br>Site 3 - 60 | 0.94<br>0.97<br>0.94 | y = 1.219x - 6.16<br>y = 0.896x + 6.87<br>y = 1.108x - 3.23 |
| Fibrinogen<br>Concentration<br>(mg/dL) | General Clinical<br>Samples | Site 1 - 28<br>Site 2 - 30<br>Site 3 - 30 | 0.97<br>0.95<br>0.96 | y = 0.735x + 43.3<br>y = 0.696x + 56.09<br>y = 0.818x - 22.07 |

## Table 1 Summary of Method Comparison Studies Between the ThromboScreen® 1000 and the MLA 900C/1600C

Precision studies were also performed to assess the performance of the TS1000. The following coefficients of variation were obtained for within-run and between-run precision studies:

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| | TS1000 | | | MLA 900C/1600C | | |
|-----------------------------|--------|--------|--------|----------------|--------|--------|
| Test | Coag 1 | Coag 2 | Coag 3 | Coag 1 | Coag 2 | Coag 3 |
| PT | | | | | | |
| Site 1 | 2.2% | 3.2% | 5.8% | 2.9% | 5.1% | 3.1% |
| Site 2 | 1.9% | 2.3% | 4.8% | | | |
| Site 3 | 1.4% | 2.2% | 2.8% | | | |
| APTT | | | | | | |
| Site 1 | 1.2% | 2.0% | 3.0% | 0.9% | 2.0% | 0.7% |
| Site 2 | 1.6% | 3.4% | 3.1% | | | |
| Site 3 | 1.5% | 1.8% | 2.0% | | | |
| Fibrinogen<br>Concentration | | | | | | |
| Site 1 | 1.2% | 2.0% | 3.0% | 0.9% | 2.0% | 0.7% |
| Site 2 | 1.6% | 3.4% | 3.1% | | | |
| Site 3 | 1.5% | 1.8% | 2.0% | | | |

Table 2 Summary of Within-Run Precision Studies, %CV

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| | | Coag 1 | Coag 2 | Coag 3 |
|--------|------------|--------|--------|--------|
| TS1000 | | | | |
| | Site 1 | | | |
| | Within-run | 2.3% | 3.0% | 4.9% |
| | Run-to-run | 2.8% | 4.3% | 8.0% |
| | Day-to-day | 3.6% | 4.5% | 9.4% |
| | Total | 2.5% | 3.7% | 6.6% |
| | Site 2 | | | |
| | Within-run | 1.1% | 1.7% | 2.3% |
| | Run-to-run | 2.1% | 2.6% | 6.9% |
| | Day-to-day | 1.8% | 2.6% | 7.4% |
| | Total | 1.8% | 2.2% | 5.1% |
| | Site 3 | | | |
| | Within-run | 1.8% | 1.8% | 2.9% |
| | Run-to-run | 2.7% | 3.2% | 4.4% |
| | Day-to-day | 3.4% | 3.5% | 4.2% |
| | Total | 2.3% | 2.6% | 3.7% |
| | | | | |
| MLA | | | | |
| | Site 1 | | | |
| | Within-run | 1.8% | 2.0% | 2.4% |
| | Run-to-run | 2.5% | 8.8% | 8.8% |
| | Day-to-day | 3.0% | 6.4% | 8.5% |
| | Total | 2.2% | 6.4% | 6.4% |
| | Site 2 | | | |
| | Within-run | 2.1% | 2.7% | 2.6% |
| | Run-to-run | 2.9% | 9.3% | 9.4% |
| | Day-to-day | 3.2% | 10.3% | 11.1% |
| | Total | 2.5% | 6.8% | 6.8% |
| | Site 3 | | | |
| | Within-run | 1.5% | 2.2% | 2.3% |
| | Run-to-run | 3.9% | 6.9% | 8.2% |
| | Day-to-day | 4.3% | 6.9% | 9.6% |
| | Total | 3.0% | 5.1% | 6.0% |
| | | Coag 1 | Coag 2 | Coag 3 |
| TS1000 | Site 1 | | | |
| | Within-run | 1.7% | 2.1% | 2.7% |
| | Run-to-run | 2.9% | 5.3% | 2.9% |
| | Day-to-day | 2.2% | 7.2% | 3.3% |
| | Total | 2.4% | 4.0% | 2.9% |
| | Site 2 | | | |
| | Within-run | 1.4% | 1.7% | 1.9% |
| | Run-to-run | 4.9% | 4.9% | 4.8% |
| | Day-to-day | 4.5% | 4.5% | 5.9% |
| | Total | 3.8% | 3.8% | 4.4% |
| | Site 3s | | | |
| | Within-run | 2.2% | 1.7% | 2.3% |
| | Run-to-run | 6.0% | 7.1% | 10.4% |
| | Day-to-day | 7.3% | 7.2% | 13.2% |
| | Total | 4.5% | 5.1% | 7.5% |
| MLA | Site 1 | | | |
| | Within-run | 1.5% | 0.4% | 0.7% |
| | Run-to-run | 2.6% | 3.6% | 3.8% |
| | Day-to-day | 2.9% | 4.4% | 3.6% |
| | Total | 2.2% | 2.5% | 2.7% |
| | Site 2 | | | |
| | Within-run | 1.1% | 0.8% | 0.9% |
| | Run-to-run | 3.1% | 3.3% | 3.4% |
| | Day-to-day | 3.2% | 3.3% | 3.8% |
| | Total | 2.3% | 3.7% | 2.5% |
| | Site 3 | | | |
| | Within-run | 0.9% | 0.9% | 0.8% |
| | Run-to-run | 6.1% | 8.0% | 7.6% |
| | Day-to-day | 5.8% | 10.7% | 8.9% |
| | Total | 4.2% | 5.6% | 5.3% |

Table 3a Summary of Between-Run Precision Testing - PT

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Table 3b Summary of Between-Run Precision Testing - APTT

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| | | Low Fib | | Coag 1 | | High Fib | |
|--------|------------|---------|------|--------|------|----------|------|
| | | time | conc | time | conc | time | conc |
| TS1000 | Site 1 | | | | | | |
| | Within-run | 3.2% | | 4.1% | | 5.2% | |
| | Within-day | | 5.4% | | 5.3% | | 6.4% |
| | Run-to-run | 6.7% | | 5.3% | | 8.2% | |
| | Day-to-day | 8.0% | 8.2% | 4.2% | 3.5% | 9.1% | 7.7% |
| | Total | 5.1% | 6.8% | 4.7% | 4.5% | 6.8% | 7.1% |
| | Site 2 | | | | | | |
| | Within-run | 3.5% | | 2.4% | | 4.1% | |
| | Within-day | | 3.6% | | 3.8% | | 6.5% |
| | Run-to-run | 4.4% | | 4.1% | | 8.7% | |
| | Day-to-day | 5.2% | 5.4% | 3.7% | 3.4% | 8.9% | 7.6% |
| | Total | 4.1% | 4.6% | 3.3% | 3.5% | 6.1% | 7.1% |
| | Site 3 | | | | | | |
| | Within-run | 4.9% | | 2.3% | | 3.6% | |
| | Within-day | | 8.7% | | 5.5% | | 7.5% |
| | Run-to-run | 7.8% | | 6.9% | | 9.4% | |
| | Day-to-day | 7.3% | 8.1% | 7.6% | 6.5% | 10.6% | 9.0% |
| | Total | 6.5% | 8.5% | 5.1% | 6.0% | 7.4% | 8.2% |

Table 3b Summary of Between-Run Precision Testing - Fibrinogen

In conclusion, the similar intended use, technological characteristics and performance data support the claim that the ThromboScreen® 1000 is substantially equivalent to the MLA 900C and the MLA 1600C.

Furthermore, the TS1000 specific fibrinogen assay reagent, Fibrinogen Reagent plus Kaolin, is substantially equivalent the Pacific Hemostasis® Fibrinogen Reagent.

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Image /page/7/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Jerald Steiner, Ph.D. Senior Applications Scientist Fisher Diagnostics 8365 Valley Pike P.O. Box 307 Middletown, Virginia 22645-0307

DEC 0 9 2002

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Re: k023362

Trade/Device Name: Fisher Diagnostics ThromboScreen 1000; Pacific Hemostasis Fibrinogen Reagent plus Kaolin

Regulation Number: 21 CFR § 864.5400 Regulation Name: Coagulation Instrument Regulatory Class: II Product Code: GKP, GIS Dated: October 4, 2002 Received: October 7, 2002

#### Dear Dr. Steiner:

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. Iisting 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 (QS) 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 predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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#### Page 2

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). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours,

Steven Putman

Steven I. Gutman, M.D., M.B.A. Director 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):

K023362

Device Name:

Pacific Hemostasis® Fibrinogen Reagent plus Kaolin

Sponsor Name:

Fisher Diagnostics

Indications for Use:

The Pacific Hemostasis® Fibrinogen Reagent plus Kaolin is intended to be used on the Fisher Diagnostics ThromboScreen® 1000 Coagulation Instrument for the quantitative determination of fibrinogen in plasma.

Do Not Write Below This Line - Continue on Another Page if Needed

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use Over-The-Counter Use

12

Jouchina Bautista

(Division Sign-Off) Division of Clinical Laboratory Devices 023362 510(k) Number -

{10}------------------------------------------------

# INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

KO23362

Fisher Diagnostics ThromboScreen® 1000

Sponsor Name:

Device Name: :

Fisher Diagnostics

Indications for Use:

The Fisher Diagnostics ThromboScreen® 1000 is a photo-optical instrument used for the performance of in-vitro diagnostic coagulation testing of citrated plasma specimens in the clinical laboratory. Coagulation testing capabilities of the device include routine clotting tests such as Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT), and Fibrinogen.

Do Not Write Below This Line - Continue on Another Page if Needed

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use Over-The-Counter Use

17 0

Giuseppina Fantini

(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number .