(55 days)
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No
The summary describes a reagent for a laboratory test and does not mention any AI or ML components.
No
This device is an in vitro diagnostic (IVD) device used to measure homocysteine for diagnosis and treatment of hyperhomocysteinemia, not a device that directly provides therapy.
Yes
The "Intended Use / Indications for Use" states that "Homocysteine measurements are used in the diagnosis and treatment of hyperhomocysteinemia," directly indicating its role in diagnosis.
No
The device description clearly states "Homogeneous Enzymic Homocysteine Reagent," indicating a chemical reagent, which is a physical component, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is an "in vitro device intended to measure total homocysteine quantitatively in serum or plasma." This directly aligns with the definition of an in vitro diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The "Homogeneous Enzymic Homocysteine Reagent" further supports this, as reagents are a common component of IVD test systems used to analyze biological samples.
N/A
Intended Use / Indications for Use
A homocysteine test system is an in vitro device intended to measure total homocysteine quantitatively in serum or plasma. Homocysteine measurements are used in the diagnosis and treatment of hyperhomocysteinemia.
Product codes
LPS
Device Description
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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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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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§ 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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Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services (USA). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the top half of the circle. In the center of the seal is a stylized image of an eagle with its wings spread.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL 2 5 2001
Ms. Joan Cathey Ouality Systems Director Intersect Systems, Inc. PO Box 2219 Longview, WA 98632
Re: 510(k) Number: K011692 Trade/Device Name: Homogeneous Enzymic Homocysteine Reagent Regulation Number: 862.1377 Regulatory Class: II Product Code: LPS Dated: May 25, 2001 Received: May 31, 2001
Dear Ms. Cathey:
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 to 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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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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 notification. The FDA mining of baction 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 il you desire specific advice for your actic devices), please contact the Office of Compliance at additionally 807.10 for mirrido diaglestions on the promotion and advertising of your device, (301) 594-4568. Additionally, 18. quee at (301) 594-4639. Also, please note the regulation please contact the Orneo or Compilance (21CFR 807.97). Other general entitled, TMIsoranding of reference to perched to persons of our the Division of Small
information on your responsibilities under the Act may 1001 - 1001 - 100 - 1607 miormation on your responsibilities areas and in (800) 638-2041 or (301) 443-6597 or at its Maindractdrors 115615x4200ww.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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Indication for Use
Trade Name of the Device:
Homogeneous Enzymic Homocysteine Reagent
510(k) Number: KOII 692
Classification Name; Number:
Urinary Homocystine (Nonquantitative) Test System; 21 CFR §862.1377
Indications for Use
A homocysteine test system is an in vitro device intended to measure total homocysteine quantitatively in serum or plasma. Homocysteine measurements are used in the diagnosis and treatment of hyperhomocysteinemia.
Good Luck
vision Sign-Off) (Bivision of Clinical Laboratory Devices K011692 $10(k) Number.