(687 days)
The LIASYS 600 Electrolyte Measurement System is intended for the quantitative determination of sodium, chloride, and potassium in human serum. Sodium measurements are used in the diagnosis and treatment of aldosteronism (excessive secretion of hormone aldosterone), diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. Measurements of potassium are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
The LIASYS 600 creatinine reagent is intended for the quantitative determination of creatinine in human serum. Packaged for the ease of use with LIASYS 600. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
The LIASYS 600 is a random access, computer controlled, standalone clinical analyzer intended for the in-vitro determination of analytes in human serum.
The LIASYS 600 is a random access, computer controlled, standalone clinical analyzer intended for the in-vitro determination of analytes in human serum.
This FDA document describes the clearance of the LIASYS 600 Electrolyte Measurement System and LIASYS 600 Creatinine reagent. It does not contain information about acceptance criteria or specific study results that proves the device meets acceptance criteria. The document only confirms that the device is substantially equivalent to legally marketed predicate devices for the specified indications for use.
Therefore, I cannot provide the requested information based on the provided text. The document is a 510(k) clearance letter, which affirms substantial equivalence rather than detailing performance acceptance criteria and study findings.
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June 12, 2019
AMS Diagnostics Samuel Burgos Director of Operations 1790 N Commerce Parkway Weston, FL 33326
Re: K172232
Trade/Device Name: LIASYS 600 Electrolyte Measurement System LIASYS 600 Creatinine reagent LIASYS 600 Regulation Number: 21 CFR 862.1665 Regulation Name: Sodium test system Regulatory Class: Class II Product Code: JGS, CEM, CGZ, CGX, JJE Dated: May 15, 2019 Received: May 16, 2019
Dear Samuel Burgos:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Kellie B. Kelm, Ph.D. Acting Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K172232
Device Name
LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 600
Indications for Use (Describe)
The LIASYS 600 Electrolyte Measurement System is intended for the quantitative determination of sodium, chloride, and potassium in human serum. Sodium measurements are used in the diagnosis and treatment of aldosteronism (excessive secretion of hormone aldosterone), diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. Measurements of potassium are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
The LIASYS 600 creatinine reagent is intended for the quantitative determination of creatinine in human serum. Packaged for the ease of use with LIASYS 600. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
The LIASYS 600 is a random access, computer controlled, standalone clinical analyzer intended for the in-vitro determination of analytes in human serum.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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§ 862.1665 Sodium test system.
(a)
Identification. A sodium test system is a device intended to measure sodium in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.(b)
Classification. Class II.