IL TEST APTT-SP

K973306 · Instrumentation Laboratory CO · GFO · Nov 4, 1997 · Hematology

Device Facts

• Record ID: K973306
• Device Name: IL TEST APTT-SP
• Applicant: Instrumentation Laboratory CO
• Product Code: GFO · Hematology
• Decision Date: Nov 4, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7925
• Device Class: Class 2

Intended Use

IL Test™ APTT-SP is intended for the in vitro diagnostic determination of Activated Partial Thromboplastin Time (APTT) in citrated plasma on IL Coagulation Systems as a general screening procedure for the evaluation of the intrinsic coagulation pathway and to monitor patients receiving heparin anticoagulant therapy.

Device Story

IL Test™ APTT-SP is an in vitro diagnostic reagent used on IL Coagulation Systems to measure Activated Partial Thromboplastin Time (APTT). The device processes citrated plasma samples to evaluate the intrinsic coagulation pathway and monitor heparin therapy. It is intended for use in clinical laboratory settings by trained personnel. The output is a time-based measurement (seconds) representing the clotting time of the plasma sample. Healthcare providers use these results to assess coagulation status and adjust heparin dosage, potentially improving patient management during anticoagulant therapy.

Clinical Evidence

Method comparison study of 73 plasma samples (50 abnormal, 23 normal) compared IL Test™ APTT-SP to the predicate IL Test™ APTT-C. Correlation (r) was 0.915 on ACL 300 and 0.907 on ACL Futura. Within-run precision (CV) on ACL 300 ranged from 0.65% to 1.32% across mean values of 27.27 to 74.65 seconds. On ACL Futura, CV ranged from 0.65% to 0.93% across mean values of 27.50 to 72.38 seconds.

Technological Characteristics

In vitro diagnostic reagent for coagulation testing. Utilizes the same test principle as the predicate IL Test™ APTT-C. Designed for use on automated IL Coagulation Systems (e.g., ACL 300, ACL Futura).

Indications for Use

Indicated for in vitro diagnostic determination of APTT in citrated plasma for patients requiring evaluation of the intrinsic coagulation pathway or monitoring of heparin anticoagulant therapy.

Regulatory Classification

Identification

A partial thromboplastin time test is a device used for primary screening for coagulation abnormalities, for evaluation of the effect of therapy on procoagulant disorders, and as an assay for coagulation factor deficiencies of the intrinsic coagulation pathway.

Predicate Devices

• IL Test™ APTT-C (K881367, K871973, K924098, K951891, K961991)

Submission Summary (Full Text)

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K973306

# SECTION 3 IL Test™ APTT-SP - 510(k) SUMMARY (Summary of Safety and Effectiveness)

## Submitted by:

NOV - 4 1997

Carol Marble Regulatory Affairs Engineer Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02173 Phone: [phone] [phone] Fax:

## Contact Persons:

Carol Marble Phone: [phone] Alternate: Betty Lane Phone: [phone]

#### Summary Prepared:

September 2, 1997

#### Name of the device:

IL Test™ APTT-SP

#### Classification name(s):

| 864.7925 | Partial Thromboplastin Time Tests |
|----------|-----------------------------------|
| 81 GFO | Activated Partial Thromboplastin |

#### Identification of predicate device(s):

IL Test™ APTT-C

K881367 for ACL 100, 200, 300 & 300+ Coagulation Analyzers K871973 for ACL 1000, 2000, 3000 & 3000+ Coagulation Analyzers K924098 for MCL-2 Coagulation Analyzer K951891 for ACL Futura K961991 for ACL 6000 Coagulation Analyzer

Class II

## Description of the device/intended use(s):

IL Test™ APTT-SP is intended for the in vitro diagnostic determination of Activated Partial Thromboplastin Time (APTT) in citrated plasma on IL Coagulation Systems as a general screening procedure for the evaluation of the intrinsic coagulation pathway and to monitor patients receiving heparin anticoagulant therapy.

## Statement of how the Technological Characteristics of the Device compare to the Predicate device:

IL Test™ APTT-SP uses the same test principle as the predicate IL Test™ APTT-C and is substantially equivalent in performance, intended use, and safety and effectiveness.

#### Summary of Performance Data:

In a method comparison study evaluating 73 plasma samples (50 abnormal/23 normal), the correlation (r) of the new IL Test™ APTT-SP to the predicate IL Test™ APTT-C on the ACL 300 was 0.915 and on the ACL Futura was 0.907. On the ACL 300, within run precision accessed over multiple runs gave a CV of 0.65% (at a mean of 27.27 seconds), 0.89% (at a mean of 52.05 seconds) and 1.32% (at a mean of 74.65 seconds). On the ACL Futura, within run precision accessed over multiple runs gave a CV of 0.65% (at a mean of 27.50 seconds), 0.84% (at a mean of 50.89 seconds) and 0.93% (at a mean of 72.38 seconds).

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Carol Marble Requlatory Affairs Engineer Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, Massachusetts 02173-3190

NOV - 4 1997

K973306 Re: IL Test™ APTT-SP Trade Name: Requlatory Class: II Product Code: GFO Dated: September 2, 1997 September 3, 1997 Received:

Dear Ms. Marble:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval) , 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CDIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number [phone] or at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Putman

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 Statement

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: IL Test™ APTT-SP

# Indications for Use:

IL Test™ APTT-SP is intended for the in vitro diagnostic determination of Activated Partial Thromboplastin Time (APTT) in citrated plasma on IL Coagulation Systems as a general screening procedure for the evaluation of the intrinsic coagulation pathway and to monitor patients receiving heparin anticoagulant therapy.

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|---------|
| (Division Sign-Off) | |
| Division of Clinical Laboratory Services | |
| 510(k) Number | k973360 |

| Prescription Use (Per 21 CFR 801.019) | |
|---------------------------------------|--|
|---------------------------------------|--|

OR Over-The-Counter Use

| Section 2 | IL Test™ APTT-SP 510(k) | Page 1 of 1 |
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