(81 days)
K860371 Asserachrom® vWF
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No
The description details a standard turbidimetric immunoassay for quantitative determination of a protein, relying on light transmission measurements and standard statistical analysis (%CV, correlation) for performance evaluation. There is no mention of AI, ML, or any learning algorithms.
No.
The device is an in vitro diagnostic (IVD) device used for quantitative determination of a factor, not for therapeutic purposes.
Yes
The "Intended Use / Indications for Use" section explicitly states that "IL Test™ von Willebrand Factor is an in vitro diagnostic automated latex enhanced immunoassay for the quantitative determination of von Willebrand Factor Antigen (vWF:Ag)". The term "in vitro diagnostic" directly indicates its function as a diagnostic device.
No
The device description clearly states it is an "in vitro diagnostic automated latex enhanced immunoassay" and involves "Latex Reagent and the Reaction Buffer" and measures "decrease of transmitted light caused by the aggregates (turbidimetric immunoassay)". These are all hardware and chemical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "IL Test™ von Willebrand Factor is an in vitro diagnostic automated latex enhanced immunoassay..."
The "Device Description" section also states: "IL Test™ von Willebrand Factor is an in vitro diagnostic automated latex enhanced immunoassay..."
These statements clearly identify the device as an in vitro diagnostic product.
N/A
Intended Use / Indications for Use
IL Test™ von Willebrand Factor is an in vitro diagnostic automated latex enhanced immunoassay for the quantitative determination of von Willebrand Factor Antigen (vWF:Ag) in human citrated plasma on IL Coagulation Systems. When a plasma containing vWF:Ag is mixed with the Latex Reagent and the Reaction Buffer, the coated latex particles agglutinate. The degree of agglutination is directly proportional to the concentration of vWF:Ag in the sample and is determined by measuring the decrease of transmitted light caused by the aggregates (turbidimetric immunoassay).
Product codes (comma separated list FDA assigned to the subject device)
GGP
Device Description
IL Test™ von Willebrand Factor is an in vitro diagnostic automated latex enhanced immunoassay for the quantitative determination of von Willebrand Factor Antigen (vWF:Ag) in human citrated plasma on IL Coagulation Systems. When a plasma containing vWF:Ag is mixed with the Latex Reagent and the Reaction Buffer, the coated latex particles agglutinate. The degree of agglutination is directly proportional to the concentration of vWF:Ag in the sample and is determined by measuring the decrease of transmitted light caused by the aggregates (turbidimetric immunoassay).
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
In method comparison studies evaluating 120 citrated plasma samples with vWF:Ag levels ranging from 0.3% to 634.3% on an ACL 6000 and an ACL Futura, the slopes and correlation coefficients (r) for IL Test™ von Willebrand Factor versus the predicate device are shown below:
IL System: ACL Futura, Slope: 1.03, r: 0.997
IL System: ACL 6000, Slope: 1.00, r: 0.996
Within run precision assessed over multiple runs using both three levels of control plasma gave the following results:
ACL Futura: Normal Level Mean: 99.50, % CV: 3.51; Abnormal Level I Mean: 79.45, % CV: 2.48; Abnormal Level II Mean: 35.54, % CV: 3.16.
ACL 6000: Normal Level Mean: 101.52, % CV: 1.41; Abnormal Level I Mean: 80.83, % CV: 1.25; Abnormal Level II Mean: 33.67, % CV: 2.18.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Slope, r, %CV
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K860371 Asserachrom® vWF
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 864.7290 Factor deficiency test.
(a)
Identification. A factor deficiency test is a device used to diagnose specific coagulation defects, to monitor certain types of therapy, to detect coagulation inhibitors, and to detect a carrier state (a person carrying both a recessive gene for a coagulation factor deficiency such as hemophilia and the corresponding normal gene).(b)
Classification. Class II (performance standards).
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Section 3 IL Test™ von Willebrand Factor - 510(k) Summary (Summary of Safety and Effectiveness)
Submitted by:
Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02421 Phone: 781-861-4467 781-861-4464 Fax:
Contact Person:
Carol Marble, Regulatory Affairs Manager Phone: 781-861-4467 / Fax: 781-861-4464
Summary Prepared:
August 11, 1999
Name of the Device:
IL Test™ von Willebrand Factor
Classification Name(s):
| 864.7290 | Factor Deficiency Test | Class II |
|---|---|---|
| 81GGP | Test, Qualitative and Quantitative Factor Deficient |
Identification of predicate device(s):
K860371 Asserachrom® vWF
Description of the device/intended use(s):
IL Test™ von Willebrand Factor is an in vitro diagnostic automated latex enhanced immunoassay for the quantitative determination of von Willebrand Factor Antigen (vWF.Ag) in human citrated plasma on IL Coagulation Systems. When a plasma containing vWF:Ag is mixed with the Latex Reagent and the Reaction Buffer, the coated latex particles agglutinate. The degree of agglutination is directly proportional to the concentration of vWF:Ag in the sample and is determined by measuring the decrease of transmitted light caused by the aggregates (turbidimetric immunoassay).
Statement of Technological Characteristics of the Device Compared to Predicate Device:
IL Test™ von Willebrand Factor is substantially equivalent to the commercially available predicate device (Asserachrom® vWF) in performance and intended use.
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Section 3 IL Test™ von Willebrand Factor - 510(k) Summary (Cont.) (Summary of Safety and Effectiveness)
Summary of Performance Data:
In method comparison studies evaluating 120 citrated plasma samples with vWF:Ag levels ranging from 0.3% to 634.3% on an ACL 6000 and an ACL Futura, the slopes and correlation coefficients (r) for IL Test™ von Willebrand Factor versus the predicate device are shown below:
| %vWF:Ag | ||
|---|---|---|
| IL System | Slope | r |
| ACL Futura | 1.03 | 0.997 |
| ACL 6000 | 1.00 | 0.996 |
Within run precision assessed over multiple runs using both three levels of control plasma gave the following results:
| %vWF:Ag | ||||
|---|---|---|---|---|
| ACL Futura | Normal | |||
| Level | Abnormal | |||
| Level I | Abnormal | |||
| Level II | ||||
| Mean | 99.50 | 79.45 | 35.54 | |
| % CV | 3.51 | 2.48 | 3.16 | |
| %vWF:Ag | ||||
| Normal | ||||
| Level | Abnormal | |||
| Level I | Abnormal | |||
| Level II | ||||
| ACL 6000 | ||||
| Mean | 101.52 | 80.83 | 33.67 | |
| % CV | 1.41 | 1.25 | 2.18 |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
NOV - 1 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Carol Marble Regulatory Affairs Manager Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, Massachusetts 02421
Re: K992704 Trade Name: IL Test™ von Willebrand Fractor Regulatory Class: II Product Code: GGP Dated: August 11, 1999 Received: August 12, 1999
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 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). 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 requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (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 (CLIA-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 (770) 488-7655.
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"(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 (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/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 Statement
510(k) Number (if known): K992704
Device Name: IL Test™ von Willebrand Factor
Indications for Use:
IL Test™ von Willebrand Factor is an in vitro diagnostic automated latex enhanced immunoassay for the quantitative determination of von Willebrand Factor Antigen (vWF:Ag) in human citrated plasma on IL Coagulation Systems. When a plasma containing vWF:Ag is mixed with the Latex Reagent and the Reaction Buffer, the coated latex particles agglutinate. The degree of agglutination is directly proportional to the concentration of vWF:Ag in the sample and is determined by measuring the decrease of transmitted light caused by the aggregates (turbidimetric immunoassay).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Pete-9. Madini
Prescription Use
(Per 21 CFR 801.019)
✓
OR Over-The-Counter Use
Section 2
IL Test™ von Willebrand Factor 510(k)
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