HEMOSIL ROUTINE CONTROL LEVEL 1, LEVEL 2, LEVEL 3 UNASSAYED

K082859 · Instrumentation Laboratory CO · GGN · Dec 19, 2008 · Hematology

Device Facts

• Record ID: K082859
• Device Name: HEMOSIL ROUTINE CONTROL LEVEL 1, LEVEL 2, LEVEL 3 UNASSAYED
• Applicant: Instrumentation Laboratory CO
• Product Code: GGN · Hematology
• Decision Date: Dec 19, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Intended Use

HemosIL Routine Control Level 1 is for the quality control of coagulation assays in the normal range. The product is intended in the assessment of precision and accuracy for PT, APTT, and Fibrinogen tests performed on coagulation systems. HemosIL Routine Control Level 2 is for the quality control of coagulation assays in the low abnormal range. The product is intended in the assessment of precision and accuracy for PT, and APTT tests performed on coagulation systems. HemosIL Routine Control Level 1 is for the quality control of coagulation assays in the high abnormal range. The product is intended in the assessment of precision and accuracy for PT, and APTT tests performed on coagulation systems.

Device Story

Lyophilized human citrated plasma controls; used for quality control of coagulation assays (PT, APTT, Fibrinogen). Level 1 derived from healthy donors; Levels 2 and 3 modified via dedicated process to simulate abnormal coagulation samples. Used in clinical laboratory settings on coagulation systems (e.g., ACL series) to assess precision and accuracy of test results. Healthcare providers use control results to verify system performance before patient sample analysis.

Clinical Evidence

Bench testing only. Precision/reproducibility assessed via within-run and between-run %CVs on ACL 9000, ACL Advance, ACL 300, and ACL 6000 systems using various HemosIL reagents. Real-time stability studies support 36-month shelf life for Level 1 and 24-month shelf life for Levels 2 and 3.

Technological Characteristics

Lyophilized human citrated plasma; contains buffers, stabilizers, and preservatives (Level 1 only). No preservatives in Levels 2 and 3. Intended for use on automated coagulation systems.

Indications for Use

Indicated for quality control of coagulation assays (PT, APTT, Fibrinogen) on coagulation systems to assess precision and accuracy. Level 1: normal range. Level 2: low abnormal range. Level 3: high abnormal range.

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

• HemosIL Normal Control (K021023)
• HemosIL Low Abnormal Control (K021022)
• HemosIL High Abnormal Control (K021024)

Submission Summary (Full Text)

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#### 510(k) Summary

#### Applicant Contact Information:

| Applicant: | Instrumentation Laboratory Co. |
|--------------------|------------------------------------------------|
| Address: | 113 Hartwell Avenue<br>Lexington, MA 02421 |
| | DEC 19 2008 |
| Contact Person: | Carol Marble, Regulatory Affairs Director |
| Alternate Contact: | Gabriella Erdosy, Regulatory Affairs Associate |
| Phone Number: | 781-861-4467 |
| Fax Number: | 781-861-4207 |
| Preparation Date: | November 7, 2008 |

#### Device Trade Names (Products Sold Separately):

HemosIL Routine Control Level 1

HemosIL Routine Control Level 2

HemosIL Routine Control Level 3

#### Device Regulatory Information:

| Common Name: | Plasma, Coagulation Control |
|--------------------|-----------------------------|
| Classification: | Class II |
| Product Code: | GGN |
| Regulation Number: | 21 CFR 864.5425 |

#### Identification of Predicate Devices:

| K021023 | HemosIL Normal Control |
|---------|-------------------------------|
| K021022 | HemosIL Low Abnormal Control |
| K021024 | HemosIL High Abnormal Control |

#### Device Descriptions:

- The HemosIL Routine Control Level 1 is a lyophilized product prepared using human citrated ● plasma from healthy donors. It contains buffer, stabilizers and preservatives.
- The HemosIL Routine Control Level 2 is a lyophilized product prepared using human citrated . plasma from healthy donors (not heparinized plasma samples under oral anticoagulant therapy) and modified, by means of a dedicated process, to stimulate an abnormal coagulation sample. It contains buffer and stabilizers. No preservatives are included.
- The HemosIL Routine Control Level 3 is a lyophilized product prepared using human citrated . plasma from healthy donors (not heparinized plasma samples under oral anticoagulant therapy) and modified, by means of a dedicated process, to stimulate an abnormal coagulation sample. It contains buffer and stabilizers. No preservatives are included.

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#### Device Indications for Uses:

- . HemosIL Routine Control Level 1 is for the quality control of coagulation assays in the normal range. The product is intended in the assessment of precision and accuracy for PT, APTT and Fibrinogen tests performed on coagulation systems.
- HemosIL Routine Control Level 2 is for the quality control of coagulation assays in the low . abnormal range. The product is intended in the assessment of precision and accuracy for PT and APTT tests performed on coagulation systems.
- HemosIL Routine Control Level 3 is for the quality control of coagulation assays in the high . abnormal range. The product is intended in the assessment of precision and accuracy for PT and APTT tests performed on coagulation systems.

#### Statement of Technological Characteristics of the Device Compared to Predicate Devices:

HemosIL Routine Control Levels 1, 2 and 3 are substantially equivalent to the predicate devices in performance, intended use and safety and effectiveness for the claimed analytes.

| Characteristic | New Device:<br>HemosIL Routine Control Level 1 | Predicate Device:<br>HemosIL Normal Control<br>(K021023) |
|----------------|---------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| Intended Use | For the quality control of<br>coagulation assays in the normal<br>range. | Same, except additional analytes are<br>claimed for the indications for use. |
| Matrix | Human Plasma | Same |
| Form | Lyophilized | Same |
| Characteristic | New Device:<br>HemosIL Routine Control Level 2 | Predicate Device:<br>HemosIL Low Abnormal Control<br>(K021022) |
| Intended Use | For the quality control of<br>coagulation assays in the low<br>abnormal range. | Same, except additional analytes are<br>claimed for the indications for use. |
| Matrix | Human Plasma | Same |
| Form | Lyophilized | Same |
| Characteristic | New Device:<br>HemosIL Routine Control Level 3 | Predicate Device:<br>HemosIL High Abnormal Control<br>(K021024) |
| Intended Use | For the quality control of<br>coagulation assays in the high<br>abnormal range. | Same, except additional analytes are<br>claimed for the indications for use. |
| Matrix | Human Plasma | Same |
| Form | Lyophilized | Same |

#### Substantial Equivalence Comparison Table:

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#### Summary Performance Data:

#### Precision

Within run precision was assessed over multiple runs using the three levels of HemosIL Routine Control with specific lots of reagents on representative coagulation systems:

| HemosIL Routine Control Level 1 | | | | |
|------------------------------------------------------------|------------------------------------------------------|-------------|----------------|-------------------|
| Analyte | Reagent | Instrument | Mean<br>(n=80) | Within-Run<br>%CV |
| Prothrombin<br>Time (PT)<br>(Seconds) | HemosIL<br>PT-Fibrinogen<br>Recombinant<br>(K981479) | ACL 9000 | 9.9 | 2.27 |
| | HemosIL<br>PT-Fibrinogen<br>(K862301) | ACL Advance | 11.5 | 1.48 |
| | HemosIL<br>PT-Fibrinogen<br>HS Plus<br>(K060931) | ACL 300 | 13.4 | 1.46 |
| Fibrinogen<br>(mg/dL) | HemosIL<br>PT-Fibrinogen<br>Recombinant<br>(K981479) | ACL 6000 | 270.9 | 3.91 |
| | HemosIL<br>PT-Fibrinogen<br>(K862301) | ACL Advance | 319.0 | 3.13 |
| | HemosIL<br>PT-Fibrinogen<br>HS Plus<br>(K060931) | ACL 300 | 283.4 | 4.41 |
| Activated Partial<br>Thromboplastin<br>(APTT)<br>(Seconds) | HemosIL<br>APTT-SP<br>(K973306) | ACL 9000 | 28.7 | 0.98 |
| | HemosIL<br>SynthAFax<br>(K955638) | ACL 6000 | 20.5 | 0.91 |
| | HemosIL<br>SynthASil<br>(K060688) | ACL Advance | 30.1 | 1.15 |

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### Summary Performance Data (Cont.):

### Precision

| HemosIL Routine Control Level 2 | | | | |
|------------------------------------------------------------|------------------------------------------------------|-------------|----------------|-------------------|
| Analyte | Reagent | Instrument | Mean<br>(n=80) | Within-Run<br>%CV |
| Prothrombin<br>Time (PT)<br>(Seconds) | HemosIL<br>PT-Fibrinogen<br>Recombinant<br>(K981479) | ACL 9000 | 27.2 | 2.49 |
| | HemosIL<br>PT-Fibrinogen<br>(K862301) | ACL Advance | 22.6 | 1.24 |
| | HemosIL<br>PT-Fibrinogen<br>HS Plus<br>(K060931) | ACL 300 | 41.3 | 1.56 |
| Activated Partial<br>Thromboplastin<br>(APTT)<br>(Seconds) | HemosIL<br>APTT-SP<br>(K973306) | ACL 9000 | 47.9 | 1.69 |
| | HemosIL<br>SynthAFax<br>(K955638) | ACL 6000 | 40.9 | 1.26 |
| | HemosIL<br>SynthASil<br>(K060688) | ACL Advance | 47.2 | 1.26 |

:

:

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## Summary Performance Data (Cont.):

## Precision

| HemosIL Routine Control Level 3 | | | | |
|------------------------------------------------------------|------------------------------------------------------|-------------|----------------|-------------------|
| Analyte | Reagent | Instrument | Mean<br>(n=80) | Within-Run<br>%CV |
| Prothrombin<br>Time (PT)<br>(Seconds) | HemosIL<br>PT-Fibrinogen<br>Recombinant<br>(K981479) | ACL 9000 | 37.0 | 2.65 |
| | HemosIL<br>PT-Fibrinogen<br>(K862301) | ACL Advance | 31.4 | 2.61 |
| | HemosIL<br>PT-Fibrinogen<br>HS Plus<br>(K060931) | ACL 300 | 63.5 | 1.40 |
| Activated Partial<br>Thromboplastin<br>(APTT)<br>(Seconds) | HemosIL<br>APTT-SP<br>(K973306) | ACL 9000 | 60.7 | 0.62 |
| | HemosIL<br>SynthAFax<br>(K955638) | ACL 6000 | 55.4 | 1.98 |
| | HemosIL<br>SynthASil<br>(K060688) | ACL Advance | 56.3 | 1.14 |

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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 with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is depicted in black, and the text is also in black against a white background.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 1 9 2008

Instrumentation Laboratory Co. C/o Carol Marble 113 Hartwell Avenue Lexington, Massachusetts 02421

Rc: k082859

Trade/Device Name: HemosIL Routine Control Level 1, 2, and 3 Regulation Number: 21 CFR 864.5425 Regulation Name: Multipurpose System for In Vitro Coagulation Studies Regulatory Class: Class II Product Code: GGN Dated: September 26, 2008 Received: September 29, 2008

Dear Ms. Marble:

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 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

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Page 2 - Ms. Marble

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,

Josephine Bautista
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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### Indications for Use Statement

182859 510(k) Number (if known):

Device Name: HemosIL Routine Control Levels 1, 2 and 3

#### Indications for Use:

- Hemos L Routine Control Level 1 is for the quality control of coagulation assays in the . normal range. The product is intended in the assessment of precision and accuracy for PT, APTT and Fibrinogen tests performed on coagulation systems.
- Hemos IL Routine Control Level 2 is for the quality control of coagulation assays in the low . abnormal range. The product is intended in the assessment of precision and accuracy for PT and APTT tests performed on coagulation systems.
- . HemosIL Routine Control Level 3 is for the quality control of coagulation assays in the high abnormal range. The product is intended in the assessment of precision and accuracy for PT and APTT tests performed on coagulation systems.

For in vitro diagnostic use.

V Prescription Use (Part 21 CFR 801 Subpart D)

OR

Over-The-Counter Use (21 CFR 807 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)

Josephine Bautista
Division Sign Off

Office of In Vitro Diagnostic Device Evaluation and Safe

- 510(k)

K082859

Attachment A