HEMOSIL D-DIMER HS 500 CONTROL

K133582 · Instrumentation Laboratory · GGN · Aug 15, 2014 · Hematology

Device Facts

• Record ID: K133582
• Device Name: HEMOSIL D-DIMER HS 500 CONTROL
• Applicant: Instrumentation Laboratory
• Product Code: GGN · Hematology
• Decision Date: Aug 15, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Intended Use

HemosIL D-Dimer HS 500 Controls are assayed, human-sourced controls intended for the quality control of the HemosIL D-Dimer HS 500 assay as performed on the ACL TOP Family System, in a clinical laboratory setting. The controls are intended for in vitro diagnostic use. Level 1 D-D HS 500 Control is intended for the assessment of the assay around the clinical cutoff for VTE (500 ng/mL FEU). Level 2 D-D HS 500 Control is intended for the assessment of precision and accuracy of the assay at abnormal D-Dimer levels (above the cut-off).

Device Story

Liquid control materials containing partially purified D-Dimer (derived from human fibrin digested with human plasmin); used for quality control of HemosIL D-Dimer HS 500 assay on ACL TOP family analyzers. Device provides known concentrations of D-Dimer to verify assay precision and accuracy in clinical laboratories. Healthcare providers use control results to validate instrument performance before patient sample testing; ensures reliability of D-Dimer measurements used in VTE assessment. Kit includes two levels: Level 1 (near clinical cut-off) and Level 2 (abnormal levels).

Clinical Evidence

No clinical data. Bench testing only. Precision and reproducibility studies conducted on ACL TOP 300/500/700 analyzers. Precision study (N=80 per level/instrument) showed within-run CV% 1.80-4.59% and total CV% 2.69-5.86%. Reproducibility study across three sites (N=80 per level/site) met pre-specified acceptance criteria (repeatability CV% ≤8%, total CV% ≤12% for Level 1; ≤10% for Level 2). Instrument-to-instrument variability was <10%.

Technological Characteristics

Latex-based immunoturbidimetric immunoassay. Contains partially purified D-Dimer from human fibrin digested with human plasmin, bovine serum albumin, buffer, stabilizers, and preservative. Liquid form. On-board stability 24 hours at 15-25°C; open-vial stability 1 month at 2-8°C or 3 months at -20°C. Analyzed on ACL TOP family systems.

Indications for Use

Indicated for quality control of the HemosIL D-Dimer HS 500 assay on the ACL TOP Family System in clinical laboratory settings. Level 1 assesses performance near the 500 ng/mL FEU VTE clinical cutoff; Level 2 assesses precision and accuracy at abnormal levels above the cutoff.

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.

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 15, 2014

INSTRUMENTATION LABORATORY, INC. C/O MS CAROL MARBLE REGULATORY AFFAIRS DIRECTOR 180 HARTWELL ROAD BEDFORD MA 01730-2443

Re: K133582

Trade/Device Name: HemosIL D-Dimer HS 500 Controls Regulation Number: 21 CFR 864.5425 Regulation Name: Multipurpose system for in vitro coagulation studies Regulatory Class: II Product Code: GGN Dated: June 11, 2014 Received: July 03, 2014

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the

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electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

# Maria M. Chan -S

Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K133582

Device Name HemosIL D-Dimer HS 500 Controls

#### Indications for Use (Describe)

HemosIL D-Dimer HS 500 Controls are assayed, human-sourced controls intended for the quality control of the HemosIL D-Dimer HS 500 assay as performed on the ACL TOP Family System, in a clinical laboratory setting. The controls are intended for in vitro diagnostic use.

Level 1 D-D HS 500 Control is intended for the assessment of the assay around the clinical cutoff for VTE (500 ng/mL FEU).

Level 2 D-D HS 500 Control is intended for the assessment of precision and accuracy of the assay at abnormal D-Dimer levels (above the cut-off).

# Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

# PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

# FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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