(120 days)
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No
The description details a standard immunoassay technology (CMIA) and does not mention any AI or ML components in the device description, intended use, or performance studies.
No.
The device is an in vitro diagnostic (IVD) assay designed to quantitatively determine homocysteine levels in human samples, which assists in diagnosis. It does not directly treat or prevent disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Homocysteine values can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria." This directly indicates a diagnostic purpose. Additionally, it is labeled "For in vitro diagnostic use."
No
The device is an in vitro diagnostic (IVD) assay that utilizes chemiluminescent microparticle immunoassay (CMIA) technology on a specific hardware system (ARCHITECT i System). The description details chemical reactions and physical processes, indicating it is a hardware-dependent assay, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "For in vitro diagnostic use."
- Nature of the Test: The device performs a quantitative determination of total L-homocysteine in human serum or plasma. This is a laboratory test performed on biological samples outside of the body, which is the definition of an in vitro diagnostic test.
- Purpose of the Test: The results of the test "can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria." This indicates the test is used for medical purposes in a diagnostic context.
- Components: The description mentions calibrators and controls, which are standard components of IVD assays used for quality control and accurate measurement.
N/A
Intended Use / Indications for Use
The ARCHITECT Homocysteine assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of total L-homocysteine in human serum or plasma on the ARCHITECT i System.
Homocysteine values can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.
The ARCHITECT Homocysteine Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of total 1-homocysteine in human serum or plasma.
The ARCHITECT Homocysteine Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System (reagents, calibrators and instrument), when used for the quantitative determination of total r-homocysteine in human serum or plasma.
For in vitro diagnostic use.
Product codes (comma separated list FDA assigned to the subject device)
LPS, JIT, JJX
Device Description
The ARCHITECT Homocysteine assay is a one-step immunoassay for the quantitative determination of total L-homocysteine in human serum or plasma using CMIA technology, with flexible assay protocols, referred to as Chemiflex. Bound or dimerised homocysteine (oxidized form) is reduced by dithiothreitol (DTT) to free homocysteine, which is then converted to Sadenosyl homocysteine (SAH) by the action of the recombinant enzyme S-adenosyl homocysteine hydrolase (rSAHHase) in the presence of excess adenosine. The SAH then competes with acridinium-labeled S-adenosyl cysteine for particle-bound monoclonal antibody. Following a wash stage and magnetic separation, pre-trigger and trigger solutions are added to the reaction mixture and the resulting chemiluminescence is measured as relative light units (RLUs). An indirect relationship exists between the amount of homocysteine in the sample and the RLUs detected by the ARCHITECT i System optics.
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)
Summary of Non-Clinical Performance: The ARCHITECT Homocysteine assay is substantially equivalent to the AxSYM Homocysteine assay in terms of precision, linearity and interferences as demonstrated in non-clinical performance data in this 510(k) submission.
Summary of Clinical Performance: The ARCHITECT Homocysteine assay demonstrated substantially equivalent performance to the AxSYM Homocysteine indicated by a method comparison study.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Passing-Bablok linear regression method comparison was performed on 456 plasma samples in the range of 3.70 to 49.94 umol/L. The ARCHITECT Homocysteine versus AxSYM Homocysteine gave a slope of 0.98 (95% Confidence interval 0.97 to 1.00) and an intercept of -0.74 (95% Confidence interval -0.99 to -0.54). ARCHITECT Homocysteine versus AxSYM Homocysteine gave an r value of 0.98 (95% Confidence interval 0.98 to 0.99).
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.
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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).
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.
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510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K073640
Submission correspondent:
Dr Claire Dora Regulatory Affairs Officer Axis-Shield Diagnostics, Ltd. The Technology Park Dundee DD2 1XA, UK Telephone: +44 13 82 422000 Date prepared: December 19, 2007
Device Name: ARCHITECT Homocysteine
Reagents:
Classification Name: Urinary Homocystine (Nonquantitative) Test System Trade Name: ARCHITECT Homocysteine Common Name: Homocysteine Enzyme Immunoassay Governing Regulation: 21 CFR 862.1377 Device Classification: Class II Classification Panel: Clinical Chemistry Product Code: LPS
Calibrators:
Classification Name: Calibrator, Secondary Trade Name: ARCHITECT Homocysteine Calibrators Common Name: Calibrator Governing Regulation: 862.1150 Device Classification: Class II Classification Panel: Clinical Chemistry Product Code: JIT
Controls:
Classification Name: Single (specified) analyte controls (assayed and unassayed) Trade Name: ARCHITECT Homocysteine Control Common Name: Control Governing Regulation: 862.1660 Device Classification: Class I Classification Panel: Clinical Chemistry Product Code: JJX
Legally marketed device to which equivalency is claimed:
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AxSYM Homocysteine Assay; K992858.
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Intended Use of Device:
The ARCHITECT Homocysteine assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of total L-homocysteine in human serum or plasma on the ARCHITECT i System.
Homocysteine values can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.
Description of Device:
The ARCHITECT Homocysteine assay is a one-step immunoassay for the quantitative determination of total L-homocysteine in human serum or plasma using CMIA technology, with flexible assay protocols, referred to as Chemiflex. Bound or dimerised homocysteine (oxidized form) is reduced by dithiothreitol (DTT) to free homocysteine, which is then converted to Sadenosyl homocysteine (SAH) by the action of the recombinant enzyme S-adenosyl homocysteine hydrolase (rSAHHase) in the presence of excess adenosine. The SAH then competes with acridinium-labeled S-adenosyl cysteine for particle-bound monoclonal antibody. Following a wash stage and magnetic separation, pre-trigger and trigger solutions are added to the reaction mixture and the resulting chemiluminescence is measured as relative light units (RLUs). An indirect relationship exists between the amount of homocysteine in the sample and the RLUs detected by the ARCHITECT i System optics.
Comparison of Technological Characteristics:
ARCHITECT Homocysteine and AxSYM Homocysteine are both automated immunoassays for the quantitative determination of total L-homocysteine in human serum or plasma.
The ARCHITECT and AxSYM systems differ in their detection methods; the ARCHITECT is a chemiluminescent microparticle immunoassay (CMIA) whereas the AxSYM is a fluorescence polarization immunoassay (FPIA).
Summary of Non-Clinical Performance:
The ARCHITECT Homocysteine assay is substantially equivalent to the AxSYM Homocysteine assay in terms of precision, linearity and interferences as demonstrated in non-clinical performance data in this 510(k) submission.
Summary of Clinical Performance:
The ARCHITECT Homocysteine assay demonstrated substantially equivalent performance to the AxSYM Homocysteine indicated by a method comparison study.
Passing-Bablok linear regression method comparison was performed on 456 plasma samples in the range of 3.70 to 49.94 umol/L. The ARCHITECT Homocysteine versus AxSYM Homocysteine gave a slope of 0.98 (95% Confidence interval 0.97 to 1.00) and an intercept of -0.74 (95% Confidence interval -0.99 to -0.54). ARCHITECT Homocysteine versus AxSYM
Homocysteine gave an r value of 0.98 (95% Confidence interval 0.98 to 0.99).
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR 2 4 2008
Axis-Shield Diagnostics, Ltd. c/o Dr. Claire Dora Acting Regulatory Affairs Manager Luna Place. The Technology Park Dundee, DD2 1XA, Scotland United Kingdom
Re: K073640
Trade/Device Name: ARCHITECT Homocysteine Reagents, ARCHITECT Homocysteine Calibrators, and ARCHITECT Homocysteine Controls Regulation Number: 21 CFR 862.1377 Regulation Name: Urinary homocystine (non-quantitative) test system. Regulatory Class: II Product Code: LPS, JIT, JJX Dated: March 13, 2008 Received: March 17, 2008
Dear Dr. Dora:
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
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This letter will allow you to begin 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Cooper, M.S., D.v.M.
Jean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indication for Use
510(k) Number (if known): K073640
Device Name: AR CHITECT Homocysteine Reagents, ARCHITECT Homocysteine Calibrators and ARCHITECT Homocysteine Controls
Indication For Use:
Reagents:
Homocysteine assay is a chemiluminescent microparticle The ARCHITECT immunoassay (CMIA) for the quantitative determination of total 1-homocysteine in human serum or plasma on the ARCHITECT i System. Homocysteine values can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.
Calibrators:
The ARCHITECT Homocysteine Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of total 1-homocysteine in human serum or plasma.
Controls:
The ARCHITECT Homocysteine Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System (reagents, calibrators and instrument), when used for the quantitative determination of total r-homocysteine in human serum or plasma.
For in vitro diagnostic use.
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use __ (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Carol C. Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K073640
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