← Product Code [KQG](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/KQG) · K021976

# FIBRON-1, FIBRON-4, QUIKCOAG, FIBRON (K021976)

_Vital Scientific N.V. · KQG · Oct 25, 2002 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/KQG/K021976

## Device Facts

- **Applicant:** Vital Scientific N.V.
- **Product Code:** [KQG](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/KQG.md)
- **Decision Date:** Oct 25, 2002
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.5400
- **Device Class:** Class 2
- **Review Panel:** Hematology

## Indications for Use

The Fibron-1 is a photo-optical instrument used for the performance of in-vitro diagnostic clotting testing of citrated plasma samples in the clinical laboratory. The Fibrin-1, which uses clot formation as an endpoint, may be used for the performance of the Prothrombin Time Test (PT) and the Activated Partial Thromboplastin Test (APTT).

## Device Story

Fibron-1 is a manual photo-optical coagulation analyzer for clinical laboratories; processes citrated plasma samples. User manually pipettes samples and reagents into cuvettes. Instrument features temperature-regulated incubator block (36.5-37.5°C) with four measuring and eight pre-warming positions. High-intensity 620 nm LED light source detects clot formation as endpoint. Output consists of clotting time measurements; used by clinicians to assess coagulation status. Manual operation distinguishes it from semi-automated predicates. Benefits include standardized, objective clot detection compared to manual visual methods.

## Clinical Evidence

Bench testing only. Precision studies (within-run and day-to-day) performed across normal and abnormal control levels. Correlation studies compared Fibron-1 against ACL 100 and Electra 900C using PT and APTT reagents. PT correlation (Fibron-1 vs ACL 100) r=0.972; APTT correlation (Fibron-1 vs ACL 100) r=0.976; APTT correlation (Fibron-1 vs Electra 900C) r=0.981. Precision CVs for PT ranged 1.01-1.28%; APTT CVs ranged 0.86-2.45%.

## Technological Characteristics

Photo-optical coagulation analyzer; 620 nm LED light source; temperature-controlled incubator (36.5-37.5°C). Manual sample/reagent handling. Standalone benchtop form factor. No software algorithm details provided beyond basic optical signal detection.

## Regulatory 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](/device/K884863.md))
- ACL 100 ([K881367](/device/K881367.md))

## Submission Summary (Full Text)

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>
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# 510(k) Summary

## Fibron-1 Coagulation Analyzer

vital scientific

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510K number is: k021976

| Applicant: | Vital Scientific NV<br>One Gateway Center, Suite 415<br>Newton, MA 02158<br>Phone: 1-617-527-9933 x41<br>Fax: 1-617-527-8230 |
|------------|------------------------------------------------------------------------------------------------------------------------------|
|------------|------------------------------------------------------------------------------------------------------------------------------|

Israel M. Stein MD Contact:

August 22, 2002 Date:

#### Device Name:

Fibron-1 (Coagulation Instrument).

#### Common Name:

Coagulation Instrument

#### Classification Name:

Coagulation Instrument has been classified as Class II device. 21 CFR 864.5400 (Product Code KQG). This device is intended for clinical use in conjunction with certain materials to measure a clot formation.

#### Description of the Fibron-1

The Fibron-1 is a photo-optical instrument used for the performance of in-vitro diagnostic clotting testing of citrated plasma samples in the clinical laboratory. The instrument utilizes photo-optical principles for clot detection. The light source is a high intensity photodiode. The incubator block is temperature regulated to 36.5 - 37.5℃ and contains four measuring positions, 4 reagent and 4 cuvette pre-warming positions.

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#### Intended Use

The Fibron-1 is a photo-optical instrument used for the performance of in-vitro diagnostic clotting testing of citrated plasma samples in the clinical laboratory. The Fibrin-1, which uses clot formation as an endpoint, may be used for the performance of the Prothrombin Time Test (PT) and the Activated Partial Thromboplastin Test (APTT).

#### Substantial Equivalence:

The Fibron-1 is comparable to the MLA-900C (K884863) and the ACL 100 (K881367). The instruments have a similar intended use for in-vitro diagnostic coagulation testing in the clinical laboratory. Further, the proposed device and the predicate devices utilize photo-optical measurement principles for clot detection. The Fibron-1 is also typical of photo-optical coagulation systems in general.

Fibron-1 is a "manual" coagulation instrument, in that the user must pipettes both sample and test reagent. In contrast, the MLA-900C is semi-automated which requires manual sample addition, but has an automatic pipette for reagent addition. The light source for the MLA instruments is a halogen lamp and the wavelenath is set at 550 nm for clotting assays. An LED at 620 nm is used by the Fibron-1. Although the Fibron-1 uses a different wavelength for clotting assays compared to the MLA, it has been optimized for this specific light source. The performance data generated support this statement.

Comparison instrument testing was performed in-house and at a community hospital and the results are shown in Tables 1 and 2. Specimens were evaluated from healthy individuals and from patients with different pathological conditions, which are expected to affect the results for a particular assay. Clotting time ranged from 10 to 39 seconds.

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Image /page/2/Figure/0 description: The image contains a table and a scatter plot. The table shows the instrument, parameter, slope, intercept, and correlation for Fibron-1 vs ACL 100 for clotting time and INR. For clotting time, the slope is 1.24, the intercept is -2.46, and the correlation is 0.972. The scatter plot shows the correlation between Fibron PT clotting times and ACL 100 PT clotting times, with a correlation of 0.972.

Table 1 Instrument to Instrument Correlation with PT Reagent.

| Table 2: Instrument to Instrument Correlation with APTT Reagent. |  |  |
|------------------------------------------------------------------|--|--|
|------------------------------------------------------------------|--|--|

| Instruments             | Correlation | Intercept | Slope |
|-------------------------|-------------|-----------|-------|
| Fibron-1 / ACL 100      | 0.976       | 6.68      | 0.763 |
| Fibron-1 / Electra 900C | 0.981       | 2.05      | 0.892 |

Image /page/2/Figure/4 description: The image is a scatter plot titled "Intrument Correlation with APTT: Fibron-1 vs Electra 900C". The x-axis is labeled "Electra 900C APTTclotting times (sec.)" and ranges from 20.0 to 90.0. The y-axis is labeled "Fibron APTT clotting times (sec.)" and ranges from 20.0 to 90.0. The data points are clustered around a straight line, indicating a strong positive correlation, and the correlation coefficient is 0.981.

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Within-run and Day--to-Day run precision studies were performed as shown in Tables 3 and 4 which summarize the data obtained from these studies.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

| Control         | Fibron-1          | MLA 900C          |
|-----------------|-------------------|-------------------|
| Control Level 1 | $12.0 \pm 2.0 \%$ | $11.5 \pm 2.0 \%$ |
| Average ± %CV   | (n = 20)          | (n = 20)          |
| Control Level 2 | $20.0 \pm 1.9 \%$ | $18.7 \pm 1.2 \%$ |
| Average ± %CV   | (n = 19)          | (n = 20)          |

## Table 3 Within-run Precision

## Table 4 – Day-to-Day Precision

ﮯ

| Table 4 - Day-to-Day Precision |                           |                           |
|--------------------------------|---------------------------|---------------------------|
| Control and Day                | Fibron-1<br>Average ± %CV | MLA 900C<br>Average ± %CV |
| Normal - Day 1                 | 12.0 ± 2.0 %<br>(n = 20)  | 11.6 ± 0.7 %<br>(n = 20)  |
| Normal - Day 2                 | 11.0 ± 2.4 %<br>(n = 4)   | 11.3±0.4 %<br>(n = 4)     |
| Normal - Day 3                 | 11.6 ± 1.5 %<br>(n = 4)   | 11.6 ± 1.6 %<br>(n = 3)   |
| Normal - Day 4                 | 11.6 ± 2.1 %<br>(n = 4)   | 11.4 ± 0.9 %<br>(n = 3)   |
| Normal - Day 5                 | 11.8 ± 1.3 %<br>(n = 4)   | 11.6 ± 1.8 %<br>(n = 4)   |
| Average ± %CV                  | 11.6 ± 3.2 %              | 11.5 ± 1.2 %              |
| Low Abnormal - Day 1           | 20.0 ± 1.9 %<br>(n = 19)  | 18.7 ± 1.2 %<br>(n = 20)  |
| Low Abnormal - Day 2           | 19.1 ± 1.4 %<br>(n = 4)   | 17.7±0.7 %<br>(n = 4)     |
| Low Abnormal - Day 3           | 19.5 ± 1.6 %<br>(n = 4)   | 18.4 ± 0.6 %<br>(n = 3)   |
| Low Abnormal - Day 4           | 19.4 ± 1.1 %<br>(n = 4)   | 18.3 ± 0.3 %<br>(n = 3)   |
| Low Abnormal - Day 5           | 20.1 ± 1.2 %<br>(n = 4)   | 18.3 ± 1.4 %<br>(n = 3)   |
| Average ± %CV                  | 19.6 ± 2.1 %              | 18.3 ± 2.0 %              |

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Precision and correlation studies were performed for PT and APTT. Tables 5 and 6 summarize the data obtained from these studies.

| PT                              | Average<br>%CV<br>of<br>Duplicates | Stand. Dev.<br>Average<br>%CV |
|---------------------------------|------------------------------------|-------------------------------|
| Normal Control<br>18 duplicates | 1.28%                              | 1.28%                         |
| Low Abnormal<br>17 duplicates   | 1.12%                              | 0.77%                         |
| High Abnormal<br>18 duplicates  | 1.01%                              | 0.75%                         |
| All levels<br>52 duplicates     | 1.14%                              | 1.14%                         |

Table 4

#### Table 5

| APTT                            | Average<br>%CV<br>of<br>Duplicates | Stand. Dev.<br>Average<br>%CV |
|---------------------------------|------------------------------------|-------------------------------|
| Normal Control<br>18 duplicates | 1.90%                              | 1.75%                         |
| Low Abnormal<br>16 duplicates   | 0.86%                              | 0.60%                         |
| High Abnormal<br>18 duplicates  | 2.45%                              | 2.77%                         |
| All levels<br>51 duplicates     | 1.59%                              | 2.03%                         |

The data for precision and accuracy demonstrate general agreement with levels that are comparable to other systems approved for marketing commercially in the United States. The data demonstrate positive correlation and substantial equivalence.

The Fibron-1 operates in the normal laboratory environment. The product does not support or sustain life and does not present a reasonable risk of illness or injury. When procedures found in the Operations Manual are followed the device is safe in general laboratory use.

Vital Scientific NV, concludes that the Fibron-1 has a similar intended use, technological characteristics and combined performance data which support the statement that the Fibron-1 is substantially equivalent to the predicate device.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with flowing lines, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol. The logo is in black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Israel M. Stein, M.D. Managing Director Vital Scientific NV One Gateway Center, Suite 415 Newton, Massachusetts 02158

> k021976 Trade/Device Name: Fibron-1 Regulation Number: 21 CFR § 864.5400 Regulation Name: Coagulation Instrument Regulatory Class: II Product Code: KQG, JBT Dated: September 18, 2002 Received: September 23, 2002

Dear Dr. Stein:

Re:

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 (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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrl/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

- 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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## INDICATIONS FOR USE STATEMEN

510(k) Number (if known): K 021976

Device Name: Fibron -1

Indications For Use: ·

The Fibron-1 is a photo-optical instrument used for the performance of in-vitro diagnostic clotting testing of citrated plasma samples in the clinical laboratory. The Fibrin-1, which uses clot formation as an endpoint, may be used for the performance of the Prothrombin Time Test (PT) and the Activated Partial Thromboplastin Test (APTT).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Josephine Bautista

(Division Sign-Off)
Division of Clinical Laboratory Devices

510(k) Number-

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use (Optional Format 1-2-96)

---

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