(162 days)
No
The summary describes a chromogenic assay for measuring heparin levels and mentions performance data determined using a specific instrument (Electra 900C®). There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the device description, intended use, or performance studies. The performance studies focus on method comparison and precision, which are standard for in vitro diagnostic assays.
No
This device is an in vitro diagnostic (IVD) assay used to quantitatively determine therapeutic heparin levels in human plasma by measuring factor IIa inhibition. It is not an instrument that directly provides therapy to a patient.
Yes
The "Intended Use / Indications for Use" states that the kit is "for in vitro diagnostic use," indicating its role in diagnosing and monitoring health conditions.
No
The device is an in vitro diagnostic (IVD) kit, which is a physical product containing reagents and other materials for laboratory testing. It is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "This kit is for in vitro diagnostic use."
N/A
Intended Use / Indications for Use
ACTICHROME® Heparin (anti-fIIa) is a chromogenic assay intended for the quantitative determination of therapeutic heparin in human plasma by measurement of factor IIa (thrombin) inhibition. The Electra 900C® was used to determine performance data. This kit is for in vitro diagnostic use.
Product codes
KFF
Device Description
Not Found
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
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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
Method comparison studies versus the predicate device were performed with one lot of ACTICHROME Heparin (anti-fila). The regression statistics in Table 1 indicate a positive correlation between the ACTICHROME Heparin (anti-flla) assay and the predicate device.
Table 1: Correlation (Y= ACTICHROME, X= predicate device)
Lot 010 (N=88): Regression Equation Y=0.845X+.027, R=0.967, Sy.x (ng/ml) = 0.03, Sample Range (ng/ml) = 0.02-0.71
Lot 010 (N=32): Regression Equation Y=0.764X+.032, R=0.917, Sy.x (ng/ml) = 0.05, Sample Range (ng/ml) = 0.00-0.55
Precision studies evaluated intra-assay and inter-assay variability:
Table 2a: Precision N=80
ACTICHROME Heparin (anti-IIa) Lot 010:
Hepanorm Control 6: Mean (USP/ml) = 0.42, Intra-Assay CV% = 4.7, Inter-Assay CV% = 7.6
Hepanorm Control 3: Mean (USP/ml) = 0.23, Intra-Assay CV% = 10.8, Inter-Assay CV% = 9.6
Table 2a: Precision N=40
ACTICHROME Heparin (anti-IIa) Lot 010:
Control Plasma spiked with 0.5 U/ml Heparin: Mean (USP/ml) = 0.51, Intra-Assay CV% = 3.8, Inter-Assay CV% = 8.5
Control Plasma spiked with 0.25 U/ml Heparin: Mean (USP/ml) = 0.23, Intra-Assay CV% = 9.5, Inter-Assay CV% = 9.4
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.7525 Heparin assay.
(a)
Identification. A heparin assay is a device used to determine the level of the anticoagulant heparin in the patient's circulation. These assays are quantitative clotting time procedures using the effect of heparin on activated coagulation factor X (Stuart factor) or procedures based on the neutralization of heparin by protamine sulfate (a protein that neutralizes heparin).(b)
Classification. Class II (performance standards).
0
APR 1 6 2002
Section 3
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS ACTICHROME® Heparin (anti-fIIa) Heparin Assay (per 21CFR864.7525)
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K013637
Submitted by:
American Diagnostica Inc. 222 Railroad Avenue Greenwich, CT 06830 Phone: 203 661-0000 203 661-7784 Fax:
Contact:
Clare Santulli Field Trial Coordinator Phone: 203 661-0000
Summary Revised
March 21, 2002
Name of the Device:
ACTICHROME® Heparin (anti-fIIa) Product No. 820
Classification:
864.7525 Heparin Assay, Class II Product Code KFF
Predicate Device:
Spectrolyse® Heparin (anti-IIa) K972209
Intended Use:
ACTICHROME® Heparin (anti-fila) is a chromogenic assay intended for the quantitative determination of therapeutic heparin in human plasma by measurement of factor IIa (thrombin) inhibition. The Electra 900C® was used to determine performance data.
1
Summary of Substantial Equivalence:
ACTICHROME Heparin (anti-flla) kit is substantially equivalent to the commercially available predicate device, Spectrolyse® Heparin (anti-IIa), manufactured by Biopool International, Ventura, CA, in performance and intended use.
Summary of Performance Data:
Method Comparison
Method comparison studies versus the predicate device were performed with one lot of ACTICHROME Heparin (anti-fila). The regression statistics in Table 1 indicate a positive correlation between the ACTICHROME Heparin (anti-flla) assay and the predicate device.
| ACTICHROME
Heparin (anti-fIIa) | N | Regression Equation | R | Sy.x
(ng/ml) | Sample Range
(ng/ml) |
|-----------------------------------|----|---------------------|-------|-----------------|-------------------------|
| Lot 010 | 88 | $Y=0.845X+.027$ | 0.967 | 0.03 | 0.02-0.71 |
| Lot 010 | 32 | $Y=0.764X+.032$ | 0.917 | 0.05 | 0.00-0.55 |
Table 1: Correlation (Y= ACTICHROME, X= predicate device)
Precision
Precision studies evaluated intra-assay and inter-assay variability with 2 control samples run in replicates of 4 over 20 runs (N=80 per control) and with two control samples run in replicates of 4 over 10 runs (N=40 per control), respectively.
Table 2a: Precision N=80
| ACTICHROME
Heparin (anti-IIa)
Lot 010 | Mean
(USP/ml) | Intra-Assay
CV% | Inter-Assay
CV% |
|---------------------------------------------|------------------|--------------------|--------------------|
| Hepanorm Control 6 | 0.42 | 4.7 | 7.6 |
| Hepanorm Control 3 | 0.23 | 10.8 | 9.6 |
Table 2a: Precision N=40
| ACTICHROME
Heparin (anti-IIa) Lot 010 | Mean
(USP/ml) | Intra-Assay
CV% | Inter-Assay
CV% |
|----------------------------------------------|------------------|--------------------|--------------------|
| Control Plasma spiked with 0.5 U/ml Heparin | 0.51 | 3.8 | 8.5 |
| Control Plasma spiked with 0.25 U/ml Heparin | 0.23 | 9.5 | 9.4 |
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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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR 1 6 2002
Mr. John B. Berryman Director of Regulatory Affairs American Diagnostics Inc. 222 Railroad Avenue Greenwich, Connecticut 06830
Re: K013637
Trade/Device Name: ACTICHROME® Heparin Assay (anti-fIIa) Regulation Number: 21 CFR § 864.7525 Regulation Name: Heparin Assay Regulatory Class: II Product Code: KFF Dated: March 22, 2002 Received: March 25, 2002
Dear Mr. Berryman:
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 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2
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 nvedicate 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 11 you doshe open 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer 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 Autman
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
4
510(k) Notification
Section 2
STATEMENT OF INDICATIONS FOR USE
Applicant: ___________________________________________________________________________________________________________________________________________________________________
510(k) Number: K013637
Device:
Indications for Use:
ACTICHROME® Heparin (anti-flia) is a chromogenic assay intended for the quantitative determination of therapeutic heparin in human plasma by measurement of factor IIa (thrombin) inhibition. The Electra 9000 was used to determine performance data.
This kit is for in vitro diagnostic use.
Josephine Bautista
(Division Sign-Off) Division of Clinical Laboratory Devices
510(k) Number.
Concurrence of CDRH, Office of Device Evaluation (ODE)