(51 days)
K 992858
Not Found
No
The device description details a competitive immunoassay using chemiluminescent technology, which is a standard laboratory technique. There is no mention of AI or ML in the intended use, device description, or any of the provided sections. The performance study describes a method comparison using linear regression, a statistical method, not an AI/ML technique.
No
This device is an in vitro diagnostic test designed to measure a specific substance (total homocysteine) in biological samples to aid in diagnosis, not to treat a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states "Intended for in vitro diagnostic use" and that the measurement "can aid in the diagnosis and treatment of patients". This clearly indicates its purpose as a diagnostic device.
No
The device description clearly outlines a competitive immunoassay using reagents and a chemiluminescent technology, indicating a hardware-based in vitro diagnostic system (ACS:180 System) is required for its function.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states: "Intended for in vitro diagnostic use in the quantitative determination of total homocysteine (HCY) in serum or EDTA plasma..." This is the primary indicator of an IVD.
- Diagnostic Purpose: The intended use also mentions that the measurement "can aid in the diagnosis and treatment of patients suspected of having homocysteinuria or hyperhomocysteinemia." This clearly indicates a diagnostic purpose.
- Sample Type: The device analyzes biological samples (serum or EDTA plasma), which is characteristic of IVDs.
- Measurement Method: The "Device Description" details a laboratory-based assay (competitive immunoassay using chemiluminescent technology) performed on these samples.
All these factors align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the compatibility of transfused blood, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
Intended for in vitro diagnostic use in the quantitative determination of total homocysteine (HCY) in serum or EDTA plasma using the ACS:180 System. This diagnostic test is designed to quantitatively measure HCY in serum or EDTA plasma. Such measurement can aid in the diagnosis and treatment of patients suspected of having homocysteinuria or hyperhomocysteinemia.
Product codes (comma separated list FDA assigned to the subject device)
LPS, JIS
Device Description
The ACS:180 HCY assay is a competitive immunoassay using direct, chemiluminescent technology. It is intended to measure the amino acid Homocysteine (HCY) in serum or EDTA plasma. The homocysteine assay requires four separate reagents, which are added sequentially. A Reducing Reagent releases protein bound and dimerized HCY in a sample or control to free HCY. A Enzyme Reagent uses the enzyme S-adenosylhomocysteine hydrolase to convert the free HCY to S-adenosylhomocysteine (SAH). SAH from a calibrator, control, or sample competes with SAH bound to the Solid Phase for binding to a monoclonal anti SAH antibody-acridinium ester conjugate in the Lite Reagent. Following incubation. unbound SAH and anti SAH-acridinium ester conjugate are washed from the Solid Phase. The chemiluminescence of the acridinium ester bound to the Solid Phase is measured. The amount of chemiluminescence is inversely proportional to the amount of HCY that was present in the sample.
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
Not Found
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)
Method Comparison. 106 samples were assayed on both systems and vielded the following linear regression statistics: IMx = 0.98 (ACS:180) + 0.43 µmol/L, R = 0.981
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K 992858
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.
Not Found
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
§ 862.1377 Urinary homocystine (nonquantitative) test system.
(a)
Identification. A urinary homocystine (nonquantitative) test system is a device intended to identify homocystine (an analogue of the amino acid cystine) in urine. The identification of urinary homocystine is used in the diagnosis and treatment of homocystinuria (homosystine in urine), a heritable metabolic disorder which may cause mental retardation.(b)
Classification. Class II.
0
DEC 21 2001
Bayer Diagnostics ACS:180 HCY Assay
Section 2 - Summary of Safety and Effectiveness
-
- Submitter Information
Contact Person: | Kenneth T. Edds, Ph.D. | |
---|---|---|
Address: | Bayer Diagnostic Corporation | |
511 Benedict Ave. | ||
Tarrytown, N.Y. 10591 | ||
Phone: (914) 524 2446 | ||
FAX: (914) 524 2500 | ||
e-mail: ken.edds.b@bayer.com | ||
Date Summary Prepared: | 10/24/01 | |
2. | Device Information | |
Propriety Name: | ACS:180 HCY Assay | |
Common Name: | HCY assay | |
Classification Name: | ||
Class: | ||
CFR: | ||
Product Code: | Homocysteine Assay | |
II | ||
862.1377 | ||
75 LPS |
-
- Predicate Device Information
Name: | IMx Homocysteine | |
---|---|---|
Manufacturer: | ||
Manufactured by: | Axis-Shield ASA | |
Ulvenveien 87 | ||
N-0581 Oslo, Norway | ||
Manufactured for: | Abbott Laboratories | |
Abbott Park Road | ||
Abbott Park, Il. 60064 | ||
510(k) Number: | K 992858 |
1
4. Device Description
The ACS:180 HCY assay is a competitive immunoassay using direct, chemiluminescent technology. It is intended to measure the amino acid Homocysteine (HCY) in serum or EDTA plasma. The homocysteine assay requires four separate reagents, which are added sequentially. A Reducing Reagent releases protein bound and dimerized HCY in a sample or control to free HCY. A Enzyme Reagent uses the enzyme S-adenosylhomocysteine hydrolase to convert the free HCY to S-adenosylhomocysteine (SAH). SAH from a calibrator, control, or sample competes with SAH bound to the Solid Phase for binding to a monoclonal anti SAH antibody-acridinium ester conjugate in the Lite Reagent. Following incubation. unbound SAH and anti SAH-acridinium ester conjugate are washed from the Solid Phase. The chemiluminescence of the acridinium ester bound to the Solid Phase is measured. The amount of chemiluminescence is inversely proportional to the amount of HCY that was present in the sample.
-
- Statement of Intended Use
Intended for in vitro diagnostic use in the quantitative determination of total homocysteine (HCY) in serum or EDTA plasma using the ACS:180 System. This diagnostic test is designed to quantitatively measure HCY in serum or EDTA plasma. Such measurement can aid in the diagnosis and treatment of patients suspected of having homocysteinuria or hyperhomocysteinemia.
- Statement of Intended Use
6. Summary of Technological Characteristics
The ACS:180 HCY assay is similar to the Abbott IMx Homocysteine assay in several ways. Both require a chemical and enzymatic step to occur before the actual immunoassay starts. The similarities between the Bayer and Abbott reagents are summarized below:
| Step | Bayer Active
Compound(s) | Abbott Active
Compound(s) |
|--------------------------------------------------------|--------------------------------------|--------------------------------------|
| | | |
| Chemical reduction of protein bound HCY to
free HCY | Dithiothreitol | Dithiothreitol |
| Enzymatic conversion of HCY to SAH | S-adenosyl
homocysteine hydrolase | S-adenosyl
homocysteine hydrolase |
| Analyte in Calibrator | SAH | SAH |
| Antibody | Mouse monoclonal anti-
SAH | Mouse monoclonal anti-
SAH |
The systems differ in their detection systems, Abbott assay uses fluorescence polarization while the ACS:180 uses chemiluminescence.
7. Method Comparison
We have compared the ACS:180 HCY assay to the Abbott IMx Homocysteine assay in performance. 106 samples were assayed on both systems and vielded the following linear regression statistics:
IMx = 0.98 (ACS:180) + 0.43 µmol/L, R = 0.981
2
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 or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird figure.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 2 1 2001
Kenneth T. Edds, Ph.D. Manager, Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, NY 10591-5097
K013606 Re:
Trade/Device Name: Homocysteine Assay for the ACS:180 Regulation Number: 21 CFR 862.1377; 21 CFR 862.1150 Regulation Name: Urinary homocystine (non-quantitative) test system; Calibrator Regulatory Class: Class II; Class II Product Code: LPS; JIS Dated: October 29, 2001 Received: October 31, 2001
Dear Dr. Edds:
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 for are and in to May 28, 1976, the enactment date of the Medical Device Amendments, or to conimer to Prize to 112) 2011 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 Orth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
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 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 1 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" (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/cdrb/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
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
Page 1 of 1
大013606 510(k) Number:
Device Name: HCY Assay for the ACS:180
Indications for Use:
Intended for in vitro diagnostic use in the quantitative determination of total homocysteine (HCY) in serum or EDTA plasma using the ACS:180® System. This nomocyooms (1101) igned to quantitatively measure HCY in serum or EDTA diagnosis tool is acception of can aid in the diagnosis and treatment of patients suspected of having homocysteinuria or hyperhomocysteinemia.
Thomas C. Mort for Ann Cooper
(Division Sign-Off)
Division of Clinical Laboratory 510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-CounterUse
(Optional Format 1-2-96)