SPOTCHEM II LDH TEST

K050790 · Arkray, Inc. · CFH · Jun 6, 2005 · Clinical Chemistry

Device Facts

• Record ID: K050790
• Device Name: SPOTCHEM II LDH TEST
• Applicant: Arkray, Inc.
• Product Code: CFH · Clinical Chemistry
• Decision Date: Jun 6, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1440
• Device Class: Class 2

Intended Use

The SPOTCHEM II LDH test is intended to measure the activity of the enzyme lactate dehydrogenase in serum, plasma, and whole blood. 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.

Device Story

SPOTCHEM II LDH test is an in vitro diagnostic reagent system for measuring lactate dehydrogenase activity. Input samples include serum, plasma, or whole blood. The device utilizes enzymatic reaction principles to quantify LDH levels. Used in clinical settings by healthcare professionals to assist in diagnosing and monitoring liver conditions, myocardial infarction, and specific tumors. Output is a quantitative LDH measurement, which clinicians use to inform diagnostic and therapeutic decisions. Benefits include rapid assessment of enzyme activity to support clinical management of hepatic and cardiac pathologies.

Clinical Evidence

No clinical data provided; the document is a 510(k) clearance letter focusing on regulatory determination of substantial equivalence.

Technological Characteristics

In vitro diagnostic reagent system for LDH measurement. Operates via enzymatic activity quantification. Designed for use with the SPOTCHEM II analyzer platform. Class II device under 21 CFR 862.1440.

Indications for Use

Indicated for the measurement of lactate dehydrogenase (LDH) activity in serum, plasma, and whole blood to aid in the diagnosis and treatment of liver diseases (e.g., acute viral hepatitis, cirrhosis, metastatic carcinoma), cardiac diseases (e.g., myocardial infarction), and tumors of the lung or kidneys.

Regulatory Classification

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.

Special Controls

*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.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20850

August 12, 2013

Arkrav, Inc. C/O Ms. Helen Landicho, RAC Director of Regulatory Affairs Polymedco Inc. 510 Furnace Dock Rd. COURTLANDT MANOR NY 10567

Re:k050790

Trade/Device Name: Arkray SPOTCHEM II LDH test Regulation Number: 21 CFR 862.1440 Regulation Name: Lactate dehydrogenase test system Regulatory Class: Class II Product Code: CFH Dated: March 18, 2005 Received: March 31, 2005

Dear Ms. Landicho:

This letter corrects our substantially equivalent letter of June 6, 2005.

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. 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 [SELECT ONE: Part 801 [or, for IVDs only] Parts 801 and 809 ] ); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809 ), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

## Carol C. Benson -S for

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): k050790

Device Name: Arkray SPOTCHEM II LDH test

Indications for Use:

The SPOTCHEM II LDH test is intended to measure the activity of the enzyme lactate dehydrogenase in serum, plasma, and whole blood. 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.

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 Diagnostics and Radiological Health (OIR)

Ruth A. Chesler -S

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

k050790 510(k)