CARESIDE LDH

{0}------------------------------------------------ C. D. E. F. Page 1 3 200-JUL May 14, 2002 K020484 ## 510(K) SUMMARY: CARESIDE LDH SAFETY AND EFFECTIVENESS #### I. Applicant Information - Applicant Name A. B. Applicant/Manufacturer Address Telephone Number # CARESIDE, Inc. 6100 Bristol Parkway Culver City, CA 90230 310-338-6767 Renate A. MacLaren, Ph.D. 310-670-6986 rmaclaren@CARESIDE.com May 14, 2002 - G. Date 510(k) Summary prepared Contact Person e-Mail Address FAX Number #### II. Device Information - A. Device Name (Trade) CARESIDE LDH Device Name B. LDH test system (Classification) C. Device Classification Clinical chemistry panel LDH test system Regulation Number: 21 CFR 862.1440 Regulatory Class II Classification Number: 75CFH D. Special controls and None applicable performance standards #### III. Substantial Equivalence Claim #### A. General Equivalency Claim The ability to monitor analyte-specific biochemical reactions in dry film and other formats is widely recognized and has gained widespread acceptance for use in chemistry assays. LDH in vitro diagnostic products, in both dry film and other formats, are legally marketed in the United States. - B. Specific equivalency claim The CARESIDE LDH test is substantially equivalent in principle, intended use, and clinical performance to the currently marketed Vitros slides for the quantitative measurement of LDH on the Vitros DT 60 II. | Name of Predicate Device: | Johnson and Johnson's (formerly Eastman Kodak, Inc.) Vitros LDH DT Slides for<br>Johnson and Johnson's Vitros DT 60<br>(formerly Eastman Kodak's DT 60 II). | | |-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | Predicate Device 510K number: | K912844/A | | | Product Code: | 75CFJ | | {1}------------------------------------------------ #### IV. Device Description CARESIDE LDH cartridges are used with the CARESIDE, Inc. CARESIDE Analyzer to measure LDH activity in anti-coagulated whole blood, serum or plasma specimens. The CARESIDE LDH cartridge, a single use disposable in vitro diagnostic test cartridge, delivers a measured volume of serum or plasma to a dry film to initiate the measurement of LDH activity. The patented film cartridge contains all reagents necessary to measure LDH activity. #### Explanation of Device Function A. The activity of the CARESIDE LDH test measures LDH activity in the direction of the conversion of lactate to pyruvate. Some other LDH tests measure the activity of the enzyme in the direction of the conversion of pyruvate to lactate. The two different methods yield clinically equivalent results when interpreted with respect to their own reference ranges although the results are different quantitatively. Each CARESIDE LDH cartridge consists of an LDH-specific multi-layer reagent film mounted in a plastic base with a hinged lid. The user introduces the specimen into the cartridge sample deposition well, closes the lid and inserts the cartridge into the CARESIDE Analyzer. Once loaded, the CARESIDE Analyzer scans the cartridge barcode, brings the cartridge and the contained specimen to 37℃, and spins the cartridge to move the sample from the sample deposition well into the cartridge channels and chambers. Approximately 8.5 microliters of sample remains in the metering passage. Any excess sample flows into an overflow well. The sample is automatically dispensed onto the multi-layer reagent film. The spreading and substrate layer distributes the LDH containing specimen uniformly. The sample moves through a reagent layer where the NADH formed in the LDH catalyzed reaction of lactate and NAD reacts with nitrotetrazolium blue (NTB) in a diaphorase catalyzed reaction to produce a bluish formazan dve. The rate of change of the dye's color intensity, as measured by the amount of reflected light at 570 nanometers, directly relates to the specimen LDH activity. ``` Test Reaction Sequence: L-Lactate + NAD+ ------------------------------------------------------------------------------------------------------------------------------------------------------------- NTB + NADH ------------------------------------------------------------------------------------------------------------------------------------------------------------------- ``` As the cartridges spin, a photodiode measures reflectance of light emitted by a wavelength-specific light emitting diode (LED) over a fixed time period. The instrument uses the reflectance measurements and the lot-specific standard curve to calculate LDH activity. {2}------------------------------------------------ #### B. Test Summary Lactate dehydrogenase (LDH) is distributed very widely in the body and is found in the in very high activities in the cytoplasm of cells in the heart, liver, kidney, and skeletal muscle, and in lesser amounts in lung, smooth muscle, erythrocytes, brain and pancreas. Because activities of LDH are much higher in tissues than in plasma, injury to tissue, with accompanying leakage of the cytoplasm into the peripheral blood, can increase the blood LDH dramatically. At least five forms of LDH are separable by electrophoresis. The predominant form in the blood varies with the tissue of origin, and therefore, LDH sub-typing may have diagnostic value. Above-normal LDH activities in blood (> 220 U/L) are seen in several hematologic, neoplastic, cardiac, hepatic, skeletomuscular, and renal diseases. Very high elevations (> 500 U/L) of LDH activity have been seen in megaloblastic anemia, extensive carcinomatosis, viral hepatitis, shock, hypoxia, and extreme hyperthermia. Somewhat lower elevations (>300 U/L) occur after myocardial or pulmonary infarction, leukemia, and hemolytic anemia. Moderate elevations occur in cirrhosis, obstructive jaundice, and neoplastic diseases. Thus, an elevated LDH activity is only a nonspecific finding. #### V. Intended Use - Intended Use A. The CARESIDE LDH cartridge is intended for in vitro diagnostic use in conjunction with the CARESIDE Analyzer to quantitatively measure LDH activity in anti-coagulated whole blood, serum or plasma. - B. Indications for Use For in vitro diagnostic use with the CARESIDE Analyzer to measure LDH activity from anti-coagulated whole blood, serum or plasma specimens to aid in the diagnosis and treatment of patients with certain liver diseases, heart diseases, and tumors of the lung, kidneys, and liver. {3}------------------------------------------------ #### Technological Characteristics VI. #### Similarities A. | | CARESIDE LDH | Vitros LDH DT Slides | |----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------| | Intended Use | For in vitro diagnostic use | Same | | Indications | Primarily to aid in the diagnosis<br>and treatment of patients with<br>certain liver diseases, heart disease,<br>and tumors of the lung, kidneys,<br>and liver. | Same | | Measurement | Quantitative | Quantitative | | Method<br>Principle | Dry film based reflectance<br>measurement of NAD reduction to<br>NADH consequent to conversion of<br>lactate to pyruvate. | Dry film based reflectance<br>measurement of NADH oxidation to<br>NAD consequent to conversion of<br>pyruvate to lactate. | | Specimen<br>Dilution | Not required | Not required | | Materials | Lithium lactate, NAD+,<br>nitrotetrazolium blue, and<br>diaphorase | NADH and sodium pyruvate | | Detector | Reflectance (570 nm) | Reflectance (340 nm) | | Test time | Approx. 4-minute warm-up (on-<br>board) plus 4 minute test time. | 15 minutes slide warm-up (off-line)<br>plus 5 minutes test time. | | Sample Type | Anti-coagulated whole<br>blood,<br>serum or plasma | Serum or plasma | | Specimen<br>Volume | 8.5 μl test volume<br>(90 ± 10 μl applied volume) | 10 μl | | Calibration | Calibration information bar-coded<br>on each cartridge. Calibration<br>information may change with each<br>lot. | Run Vitros DT II calibrators<br>whenever a new slide lot is used or<br>when necessary. | | Quality<br>Control | 2 levels | 2 levels | | Reporting<br>Units | U/L | U/L | | Reaction<br>Temp. | 37 °C | 37 °C | | | CARESIDE LDH | Vitros LDH DT Slides | | Specimen Pre-<br>treatment | Not Required | Not Required | | Reportable<br>Range | 50 to 650 U/L | 100 to 1750 U/L | | Accurate<br>pipetting | Not required | Required | | Reagent pre-<br>warming | Not required | Required | {4}------------------------------------------------ #### B. Differences #### C. Comparative Performance Characteristics | | CARESIDE LDH | Vitros LDH DT Slides | |------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------| | Detection limit | 50 U/L | 100 U/L | | Reportable range | 50 - 650 U/L | 100 - 1750 U/L | | Recovery (Mean) | 103% | Not available | | Linearity | Linearity by dilution yielded slope and correlation coefficient within acceptable limits | | | Interference | No significant interference observed at tested concentration of interferent:<br>Ascorbic Acid, 20 mg/dL<br>Bilirubin, 20 mg/dL<br>Triglycerides 3000 mg/dL | | | Precision | Total CV, 335 U/L, 7.2% | Total CV, 649 U/L, 2.9% | | Rel. Accuracy | Careside = 0.97 (BM/Hitachi 902) + 9.1 U/L r = 0.99 | | #### D. Conclusion The nonclinical and clinical data provided demonstrate that the CARESIDE LDH product is substantially equivalent to the legally marketed predicate device. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized human profiles facing to the right. JUL 3 2002 Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Renate A. MacLauren, Ph.D. Clinical Affairs Manager Careside, Inc. 6100 Bristol Parkway Culver City, CA 90230 k020484 Re: > Trade/Device Name: Careside LDH Regulation Number: 21 CFR 862.1440 Regulation Name: Lactate dehydrogenase test system Regulatory Class: Class II Product Code: CFH Dated: May 15, 2002 Received: May 16, 2002 Dear Dr. MacLauren: 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. {6}------------------------------------------------ Page 2 - 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 1 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/cdrb/dsma/dsmamain.html". Sincerely yours. Steven Butman 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 {7}------------------------------------------------ # INDICATIONS FOR USE 510(k) Number: <020484 Device Name: CARESIDE LDH Indications for use: For in vitro diagnostic use with the CARESIDE Analyzer to measure LDH activity from anti-coagulated whole blood, serum or plasma specimens to aid in the diagnosis and treatment of patients with certain liver diseases, heart diseases, and tumors of the lung, kidneys, and liver. Han Cooper (Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number K020484 ### (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) Over-The-Counter Use (Optional Format 1-2-96) OR