(67 days)
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No
The provided text describes a laboratory test system for analyzing enzyme levels and does not mention any AI or ML components or functionalities.
No
The device aids in diagnosis, which is not a therapeutic function. Therapeutic devices treat or prevent diseases/conditions.
Yes
The text states that the SPIFE LD test system can be used "to aid in the diagnosis of myocardial infarction," indicating its role in identifying a medical condition.
No
The 510(k) summary describes a "test system" and mentions "CK isoenzyme studies," which strongly implies a laboratory-based system involving physical reagents, instruments, and the analysis of biological samples, not a standalone software application.
Based on the provided information, 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 SPIFE LD test system is used "in conjunction with CK isoenzyme studies to aid in the diagnosis of myocardial infarction." This clearly indicates that the device is intended to be used on samples taken from the human body (in vitro) to provide information for diagnostic purposes.
- Analysis of Biological Samples: The description mentions analyzing "LD isoenzyme studies," which are performed on biological samples like blood.
- Diagnostic Aid: The purpose is to "aid in the diagnosis" of various conditions, including myocardial infarction, anemias, renal necrosis, liver conditions, and lymphatic system involvements. This is a core function of an IVD.
The lack of information in other sections (Device Description, image processing, AI, etc.) does not negate the fact that the intended use clearly places it within the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SPIFE LD test system can be used in conjunction with CK isoenzyme studies to aid in the diagnosis of myocardial infarction. The LD1/LD2 "flip" can be present in patients after acute MI, severe anemias, renal necrosis and in-vivo or in-vitro hemolysis of any cause.
The LD5 is increased in skeletal muscle injury or diseases, cirrhosis, hepatitis and passive liver congestion.
Mid-zone fractions (LD2,3,4) are increased in cases of massive platelet destruction (pulmonary embolism) and in lymphatic system involvements such as mononucleosis, lymphomas and lymphocytic leukemias.
Product codes
CFE
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
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.1445 Lactate dehydrogenase isoenzymes test system.
(a)
Identification. A lactate dehydrogenase isoenzymes test system is a device intended to measure the activity of lactate dehydrogenase isoenzymes (a group of enzymes with similar biological activity) in serum. Measurements of lactate dehydrogenase isoenzymes are used in the diagnosis and treatment of liver diseases, such as viral hepatitis, and myocardial infarction.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all caps and appears to be in a sans-serif font.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Patricia Franks Assistant Director of Regulatory Affairs Helena Laboratories, Inc. 1530 Lindbergh Drive P.O. Box 752 Beaumont, TX 7704-0752
OCT 01 2002
Re: K022455
Trade/Device Name: SPIFE LD-12 Isoenzyme Kit Regulation Number: 21 CFR 862.1445 Regulation Name: Lactate dehydrogenase isoenzymes test system Regulatory Class: Class II Product Code: CFE Dated: July 19, 2002 Received: July 26, 2002
Dear Ms. Franks:
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 (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.
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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 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 ' 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/cdrlvdsmamain.html".
Sincerely yours,
Steven Putman
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
2
Page of
510(k) Number (if known):
SPIFE LD-12 Isoenzyme Kit Device Name:
Indications for Use:
The SPIFE LD test system can be used in conjunction with CK isoenzyme studies to aid in the diagnosis of myocardial infarction. The LD1/LD2 "flip" can be present in patients after acute MI, severe anemias, renal necrosis and in-vivo or in-vitro hemolysis of any cause.
The LD5 is increased in skeletal muscle injury or diseases, cirrhosis, hepatitis and passive liver congestion.
Mid-zone fractions (LD2,3,4) are increased in cases of massive platelet destruction (pulmonary embolism) and in lymphatic system involvements such as mononucleosis, lymphomas and lymphocytic leukemias.
Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K022455
(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-Counter Use
(Optional Format 1-2-96)