(107 days)
No
The description details a standard automated immunoassay analyzer using chemiluminescent technology and a 4 Parameter Logistic Curve (4PLC) for data reduction. There is no mention of AI or ML algorithms being used for analysis or interpretation.
No
The device is an in vitro diagnostic (IVD) immunoassay analyzer used for the quantitative determination of D-Dimer, which aids in the diagnosis of venous thromboembolism. It is not used for treatment or therapy.
Yes
The "HemosIL AcuStar D-Dimer" is explicitly stated to be used "as an aid in the diagnosis of venous thromboembolism (VTE)". The "ACL AcuStar" is an "Automated immunoassay analyzer designed specifically for in vitro diagnostic use".
No
The device description clearly outlines a physical, automated immunoassay analyzer (ACL AcuStar) that performs chemical reactions and measures light output. While software is undoubtedly involved in controlling the instrument and processing data, the core of the device is hardware.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section for the ACL AcuStar explicitly states it is "designed specifically for in vitro diagnostic use in a clinical laboratory."
- Nature of the Test: The HemosIL AcuStar D-Dimer assay is described as a "fully automated chemiluminescent immunoassay for the quantitative determination of D-Dimer in human citrated plasma." This is a classic example of an in vitro diagnostic test, as it analyzes a biological sample (plasma) outside of the body to aid in diagnosis.
- Intended Use for Diagnosis: The intended use of the HemosIL AcuStar D-Dimer assay is "as an aid in the diagnosis of venous thromboembolism (VTE) [deep vein thrombosis (DVT) and pulmonary embolism (PE)]." This directly links the test results to a diagnostic purpose.
- Use in a Clinical Laboratory: The intended user/care setting is a "clinical laboratory," which is where IVD tests are typically performed.
- Controls: The existence of "HemosIL AcuStar D-Dimer Controls" for "quality control of D-Dimer assay performed on the ACL AcuStar" further supports its use as a regulated diagnostic test.
All these points clearly indicate that the ACL AcuStar system, along with the HemosIL AcuStar D-Dimer assay and controls, are intended for in vitro diagnostic use.
N/A
Intended Use / Indications for Use
- ACL AcuStar: Automated immunoassay analyzer designed specifically for in vitro diagnostic use in a clinical laboratory. The assay analysis is based on chemiluminescent technology. The system provides results for both direct measurements and calculated parameters.
- HemosIL AcuStar D-Dimer: Fully automated chemiluminescent immunoassay for the quantitative determination of D-Dimer in human citrated plasma on the ACL AcuStar as an aid in the diagnosis of venous thromboembolism (VTE) [deep vein thrombosis (DVT) and pulmonary embolism (PE)].
- HemosIL AcuStar D-Dimer Controls: For the quality control of D-Dimer assay performed on the ACL AcuStar.
Product codes (comma separated list FDA assigned to the subject device)
JPA, DAP, GGN
Device Description
ACL AcuStar: The AcuStar is an automated, bench-top system for lab use that measures the analyte amount in blood samples by:
- Subjecting the blood sample to reagents that cause a reaction with an antigen or antibody in the sample.
- Placing the cuvettes in a controlled environment to allow the reactants to bind into a complex.
- Separating out the complex from unused reactants.
- Treating this complex with a chemical that produces light in proportion to the analyte concentration.
- Measuring the light output to determine the amount of antibodies or antigens that were in the sample.
HemosIL AcuStar D-Dimer: The HemosIL AcuStar D-Dimer assay is a two-step immunoassay to quantify D-Dimer in human citrated plasma using magnetic particles as solid phase and a chemiluminescent detection system. In the first step, sample, anti-D-Dimer antibody coated magnetic particles, and assay buffer are combined, and the fibrin soluble derivatives containing the D-Dimer domain present in the sample bind to the anti-D-Dimer antibody coated magnetic particles. After magnetic separation and washing, an anti-XDP antibody labeled with isoluminol is added and incubated in a second step. After a new magnetic separation and washing, two triggers are added and the resulting chemiluminescent reaction is measured as relative light units (RLUs) by the ACL AcuStar optical system. The RLUs are directly proportional to the D-Dimer concentration in the sample. The ACL AcuStar D-Dimer assay utilizes a 4 Parameter Logistic Curve (4PLC) fit data reduction method to generate a Master Curve. The Master Curve is predefined lot dependent, and is stored in the instrument through the cartridge barcode. With the measurement of calibrators, the predefined Master Curve is transformed to a new, instrument specific 4PLC Working Curve. The concentration values of the calibrators are included in the calibrator plastic tube barcodes.
HemosIL AcuStar D-Dimer Controls: The Low, High, and Very High D-Dimer Controls are prepared by means of a dedicated process and contain different concentrations of partially purified D-Dimer obtained by digestion of Factor XIIIa cross-linked human fibrin with human plasmin.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinical laboratory
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision:
Precision was assessed over multiple runs using the three levels of HemosIL AcuStar D-Dimer Controls and the kit Calibrator Level 1 on an ACL AcuStar instrument.
Low D-Dimer Control: Mean (ng/m L) 234, CV% (Within run) 4.0%, CV% (Total) 6.8%
High D-Dimer Control: Mean (ng/m L) 841, CV% (Within run) 2.3%, CV% (Total) 4.9%
Very High D-Dimer Control: Mean (ng/m L) 8467, CV% (Within run) 2.5%, CV% (Total) 5.6%
Calibrator 1: Mean (ng/m L) 358, CV% (Within run) 2.7%, CV% (Total) 5.4%
Method Comparison:
An in-house method comparison study was performed to compare the performance of HemosIL AcuStar D-Dimer on an ACL AcuStar versus the VIDAS D-Dimer Exclusion Assay.
n: 179, Slope: 1.16, r: 0.888
Management Study:
A management study was performed on 344 frozen citrated plasmas from patients admitted to an emergency unit with suspected PE or DVT (frequency of venous thrombosis disease 28.2%). Of the 344 samples, 97 were confirmed as VTE positive (64 PE and 33 DVT) by standard objective tests and the remaining 247 were confirmed as negative.
ACL AcuStar: N 344, Cut-off 500 ng/mL, % Sensitivity (95% CI) 100% (96.3%-100.0%), % Specificity (95% CI) 55.5% (49.0%-61.8%), % NPV (95% CI) 100% (97.3%-100.0%)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 100% (95% CI: 96.3%-100.0%)
Specificity: 55.5% (95% CI: 49.0%-61.8%)
NPV: 100% (95% CI: 97.3%-100.0%)
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.
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.
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).
Not Found
§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
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.(b)
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.
0
510(k) Summary
Applicant Contact Information:
MAR 1 3 2009
| Applicant: | Instrumentation Laboratory Co. |
|---|---|
| Address: | 113 Hartwell Avenue |
| Lexington, MA 02421 | |
| 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: | February 26, 2009 |
Device Trade Names:
ACL™ AcuStar™ HemosIL™ AcuStar™ D-Dimer HemosIL™ AcuStar™ D-Dimer Controls
Device Regulatory Information:
| Regulation Nos.: | 21 CFR 864.7320 (Assay); 21 CFR 864.5425 (Instrument and Controls) |
|---|---|
| Regulation Names: | Multipurpose System for In Vitro Coagulation Studies |
| Fibrinogen and Fibrin Split Products, Antigen, Antiserum, Control (Assay) | |
| Plasma, Coagulation Controls (Controls) | |
| Regulatory Class: | Class II |
| Product Codes: | JPA (Instrument), DAP (Assay) and GGN (Controls) |
| Panel: | Hematology |
Predicate Devices:
| K891385 | VIDAS Instrument |
|---|---|
| K040882 | VIDAS D-Dimer Exclusion Assay |
| K073377 | ACL TOP |
| K070927 | HemosIL D-Dimer HS |
| K972696 | HemosIL D-Dimer Controls |
Device Indications for Use:
·
- . ACL AcuStar: Automated immunoassay analyzer designed specifically for in vitro diagnostic use in a clinical laboratory. The assay analysis is based on chemiluminescent technology. The system provides results for both direct measurements and calculated parameters.
- HemosIL AcuStar D-Dimer: Fully automated chemiluminescent immunoassay for the quantitative . determination of D-Dimer in human citrated plasma on the ACL AcuStar as an aid in the diagnosis of venous thromboembolism (VTE) [deep vein thrombosis (DVT) and pulmonary embolism (PE)].
- . HemosIL AcuStar D-Dimer Controls: For the quality control of D-Dimer assay performed on the ACL AcuStar.
Attachment B K083518: ACL AcuStar, HemosIL AcuStar D-Dimer and Controls Page 1 of 4
1
510(k) Summary (Cont.)
Device Descriptions:
ACL AcuStar: .
The AcuStar is an automated, bench-top system for lab use that measures the analyte amount in blood samples by:
- Subjecting the blood sample to reagents that cause a reaction with an antigen or antibody in the � sample.
- Placing the cuvettes in a controlled environment to allow the reactants to bind into a complex. . Q
- . Separating out the complex from unused reactants.
- . Treating this complex with a chemical that produces light in proportion to the analyte concentration.
- Measuring the light output to determine the amount of antibodies or antigens that were in the � sample.
. HemosIL AcuStar D-Dimer:
The HemosIL AcuStar D-Dimer assay is a two-step immunoassay to quantify D-Dimer in human citrated plasma using magnetic particles as solid phase and a chemiluminescent detection system. In the first step, sample, anti-D-Dimer antibody coated magnetic particles, and assay buffer are combined, and the fibrin soluble derivatives containing the D-Dimer domain present in the sample bind to the anti-D-Dimer antibody coated magnetic particles. After magnetic separation and washing, an anti-XDP antibody labeled with isoluminol is added and incubated in a second step. After a new magnetic separation and washing, two triggers are added and the resulting chemiluminescent reaction is measured as relative light units (RLUs) by the ACL AcuStar optical system. The RLUs are directly proportional to the D-Dimer concentration in the sample. The ACL AcuStar D-Dimer assay utilizes a 4 Parameter Logistic Curve (4PLC) fit data reduction method to generate a Master Curve. The Master Curve is predefined lot dependent, and is stored in the instrument through the cartridge barcode. With the measurement of calibrators, the predefined Master Curve is transformed to a new, instrument specific 4PLC Working Curve. The concentration values of the calibrators are included in the calibrator plastic tube barcodes.
HemosIL AcuStar D-Dimer Controls: .
The Low, High, and Very High D-Dimer Controls are prepared by means of a dedicated process and contain different concentrations of partially purified D-Dimer obtained by digestion of Factor XIIIa cross-linked human fibrin with human plasmin.
2
| 1
4
| 1 |
|---|
| P |
| POW BA == 30 MA T ============================================================================================================================================================ |
| t |
、
10(k) Summary (Cont
| Substantial Equivalence:
Differences and
Similarities | New Device:
ACL AcuStar and
HemosIL AcuStar D-Dimer
and HemosIL AcuStar D-Dimer Ctrls | Predicate Devices:
ACL TOP (K073377) with
HemosIL D-Dimer HS (K070927)
and HemosIL D-Dimer Controls
(K972696) | Predicate Devices:
VIDAS Instrument (K891385) with
VIDAS D-Dimer Exclusion Assay
(K040882) |
|-------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | Fully automated chemiluminescent
immunoassay for the quantitative
determination of D-Dimer in human
citrated plasma on the ACL AcuStar as an
aid in the diagnosis of venous
thromboembolism (VTE) [deep vein
thrombosis (DVT) and pulmonary
embolism (PE)]. | Automated latex enhanced
immunoassay for the quantitative
determination of D-Dimer in human
citrated plasma on the ACL TOP
Family Systems for use in conjunction
with a clinical pretest probability (PTP)
assessment model to exclude venous
thromboembolism (VTE) in outpatients
suspected of deep venous thrombosis
(DVT) and pulmonary embolism (PE). | Automated quantitative test for use on the
VIDAS analyzers for the immunoenzymatic
determination of fibrin degradation products
(FbDP) in citrated human plasma using the
ELFA techniques (Enzyme Linked
Fluorescent Assay). The VIDAS
D-Dimer Exclusion assay is indicated for
use in conjunction with a clinical Pre-test
Probability (PTP) assessment model to
exclude deep venous thrombosis (DVT) and
pulmonary embolism (PE) in outpatients
suspected of DVT and PE. |
| Physical Format | Single cartridge containing reagents | Lyophilized Latex Reagent | Ready-to-use strips |
| Assay Principle | Two-step chemiluminescent immunoassay | Latex-enhanced immunoturbidmetric
assay | Two-step enzyme immunoassay sandwich
method with a final fluorescent detection |
| Instrument Platform | ACL AcuStar | ACL TOP family of analyzers | VIDAS instruments |
| Sample Type | Citrated Plasma | Same | Same |
| Calibrator | D-Dimer Calibrator (included in kit) | D-Dimer Calibrator (included in kit) | D-Dimer Calibrator (included in kit) |
| Quality Controls | AcuStar D-Dimer Controls,
Low, High and Very High (sold
separately) | HemosIL D-Dimer Controls,
Low and High (sold separately) | D-Dimer Controls (included in kit) |
| Detection Limit | 6.51 ng/mL | 21 ng/mL | 45 ng/mL (FEU) |
| Linear Range | 54.3 - 1110000 ng/mL with Auto Rerun | 150 - 69000 ng/mL with Auto Rerun | 45-10000 ng/mL (FEU) |
| Clinical Cut-off | 500 ng/mL (FEU) | 230 ng/mL (D-Dimer Units) | 500 ng/mL (FEU) |
83518: ACL AcuStar, HemosIL AcuStar D-Dimer and Contro
Attachment B
Page 3 of 4
3
510(k) Summary (Cont.)
Summary Performance Data:
Precision
Precision was assessed over multiple runs using the three levels of HemosIL AcuStar D-Dimer Controls and the kit Calibrator Level 1 on an ACL AcuStar instrument:
| ACL AcuStar | Mean (ng/m L) | CV% (Within run) | CV% (Total) |
|---|---|---|---|
| Low D-Dimer Control | 234 | 4.0% | 6.8% |
| High D-Dimer Control | 841 | 2.3% | 4.9% |
| Very High D-Dimer Control | 8467 | 2.5% | 5.6% |
| Calibrator 1 | 358 | 2.7% | 5.4% |
Method Comparison
An in-house method comparison study was performed to compare the performance of HemosIL AcuStar D-Dimer on an ACL AcuStar versus the VIDAS D-Dimer Exclusion Assay with the following results:
| n | Slope | r |
|---|---|---|
| 179 | 1.16 | 0.888 |
Management Study
A management study was performed on 344 frozen citrated plasmas from patients admitted to an emergency unit with suspected PE or DVT (frequency of venous thrombosis disease 28.2%). Of the 344 samples, 97 were confirmed as VTE positive (64 PE and 33 DVT) by standard objective tests and the remaining 247 were confirmed as negative.
| Instrument | N | Cut-off | % Sensitivity
(95% CI) | % Specificity
(95% CI) | % NPV
(95% CI) |
|-------------|-----|-----------|---------------------------|---------------------------|------------------------|
| ACL AcuStar | 344 | 500 ng/mL | 100%
(96.3%-100.0%) | 55.5%
(49.0%-61.8%) | 100%
(97.3%-100.0%) |
Attachment B K083518: ACL AcuStar, HemosIL AcuStar D-Dimer and Controls
4
Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" encircles the eagle. The text is arranged in a circular fashion around the eagle, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" at the bottom and ". USA" at the top.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 1 3 2009
Instrumentation Laboratory Co. c/o Ms. Carol Marble Regulatory Affairs Director 113 Hartwell Avenue Lexington, MA 02421
Re: K083518
Trade/Device Name: ACL™ AcuStar™, HemosIL™ AcuStar™ D-Dimer and HemsIL™ AcuStar™ D-Dimer Controls
Regulation Number: 21 CFR 864.7320 Regulation Name: Fibrinogen/Fibrin Degradation Product Assay Regulatory Class: Class II Product Code: JPA, DAP, GGN Dated: February 26, 2009 Received: February 27, 2009
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
5
Page 2 - Ms. Carol Marble
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 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
ia m chan
Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety
Center for Devices and Radiological Health
Enclosure
6
Indications for Use Statement
510(k) Number (if known):
Devices Name: ACL™ AcuStar™ HemosIL™ AcuStar™ D-Dimer HemosIL™ AcuStar™ D-Dimer Controls
Indications for Use:
- ACL AcuStar: Automated immunoassay analyzer designed specifically for in vitro . diagnostic use in a clinical laboratory. The assay analysis is based on chemiluminescent The system provides results for both direct measurements and calculated technology. parameters.
- HemosIL AcuStar D-Dimer: Fully automated chemiluminescent immunoassay for the . quantitative determination of D-Dimer in human citrated plasma on the ACL AcuStar as an aid in the diagnosis of venous thromboembolism (VTE) [deep vein thrombosis (DVT) and pulmonary embolism (PE)].
- HemosIL AcuStar D-Dimer Controls: For the quality control of D-Dimer assay performed . on the ACL AcuStar.
Prescription Use
(Part 21 CFR 801 Subpart D) √
AND/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 office office official official official official official official official official official official official official official official official official official In Vitro Diagnostic Device Evaluation and Safety
510(k) K083518
Section 4
ACL AcuStar, HemosIL AcuStar D-Dimer and Controls 510(k)
Page 1 of 1