(16 days)
Not Found
Not Found
No
The summary describes a reagent set for a standard laboratory test and contains no mention of AI or ML.
No.
The device is described as being for "in vitro diagnostic use only" to determine lactate dehydrogenase in serum, which is a diagnostic purpose, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" section explicitly states that the product is "to be used in a diagnostic laboratory setting" and for "the diagnosis and treatment of myocardial infarctions," indicating its role in identifying medical conditions.
No
The device description explicitly states "Liquid LDH-L Reagent Set," indicating a physical reagent kit, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "for in vitro diagnostic use only" and describes the quantitative determination of Lactate dehydrogenase in serum or leomonogram for diagnostic purposes (diagnosis and treatment of myocardial infarctions, liver disease, etc.).
- Device Description: While the description is brief ("Liquid LDH-L Reagent Set"), it describes a reagent used in a laboratory setting for testing biological samples.
- Intended User/Care Setting: The intended user is "qualified laboratory technologists" in a "diagnostic laboratory setting," which is typical for IVDs.
The combination of these factors clearly indicates that this product is designed to be used outside of the body (in vitro) to diagnose or aid in the diagnosis of medical conditions.
N/A
Intended Use / Indications for Use
This product is to be used in a diagnostic laboratory setting, by qualified laboratory technologists, for the quantitative determination of Lactate dehydrogenase in serum or leomonogram in the for in vitro diagnostic use only. The determination of Lactate dehydrogenase in serum is most commonly performed for the diagnosis and treatment of myocardial infarctions. LD elevations are also observed in liver disease, pernicious anemia, some cases of renal disease, and in cases of skeletal muscle trauma.
Product codes
CFJ
Device Description
Liquid LDH-L Reagent Set
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
diagnostic laboratory setting, by qualified laboratory technologists
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1440 Lactate dehydrogenase test system.
(a)
Identification. A lactate dehydrogenase test system is a device intended to measure the activity of the enzyme lactate dehydrogenase in serum. Lactate dehydrogenase measurements are used in the diagnosis and treatment of liver diseases such as acute viral hepatitis, cirrhosis, and metastatic carcinoma of the liver, cardiac diseases such as myocardial infarction, and tumors of the lung or kidneys.(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 § 862.9.
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Image /page/0/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The seal is black and white.
OCT - 8 1997
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
William F. Walters, Jr. .Vice President, Technical Operations Pointe Scientific, Inc. 1025 John A. Papalas Drive Lincoln Park, Michigan 48146
K973589 Re : Liquid LDH-L Reagent Kit Regulatory Class: I Product Code: CFJ Dated: September 16, 1997 Received: September 22, 1997
Dear Mr. Waters:
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 (for the indications for use stated in the enclosure) 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 Requlations, Title 21, Parts 800 to 895. ਸੇਂ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. 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 requlations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity (chin 007) chip device may required, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA described in your six (n) pivalence 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 enc regulation chercred/ (21 CFR 807.97) Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Litman
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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Page 1 of 1
510 (k) Number (if known):__Unknown at this time
Device Name:_Liquid LDH-L Reagent Set
Indications for use:
This product is to be used in a diagnostic laboratory setting, by qualified laboratory technologists, for the quantitative determination of Lactate dehydrogenase in serum or leomonogram in the for in vitro diagnostic use only. The determination of Lactate dehydrogenase in serum is most commonly performed for the diagnosis and treatment of myocardial infarctions. LD elevations are also observed in liver disease, pernicious anemia, some cases of renal disease, and in cases of skeletal muscle trauma.
(Division Sign-Off)
Division of Clinical Labormonvic
510(k) Number K973589
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | |
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| (Per 21 CFR 801.109) |
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OR
Over-The-Counter Use