ELECTROLYTE BUFFER A443-325, ELECTROLYTE REFERENCE REAGENT A443-315, CO2 ACID REAGENT A443-330, CO2 ALKALINE BUFFER A44

{0}------------------------------------------------ SEP 1998 K982501 # 510(k) Summary for ALKO Reagents on Beckman CX® Series and Equivalent Analyzers The products encompassed by this 510(k) submission are Class II (75JIX) In Vitro Diagnostic Solutions manufactured by ALKO Diagnostic Corporation, 333 Fiske Street, Holliston, MA 01746. The Reagents are intended for use on equivalent Beckman Analyzers. Beckman Instrument is the original equipment manufacturer (OEM) of the analyzers and of predicate reagents which are necessary for the continued operation and use of the analyzers. Information herein will support ALKO's position for the intended use of these products to the equivalent Beckman Chemistry Analyzers. The Beckman Chemistry Añalyzers perform a broad array of tests. ALKO manufactures the ISE Reagents, wherein samples are analyzed for quantitative determinations of Nat, K', Cl ' and CO, by ISE method. These Reagents are intended to be used with equivalent Beckman Chemistry Analyzers. As such, ALK O products are intended to serve as direct replacements to like named products manufactured by Beckman Instrument Inc. The Electrolyte Buffer is intended to provide constant ionic strength for measuring electrolytes in the samples. As such, it is diluted with Wash Solution and introduced into the sample and/or calibrator, for quantitative determination of Nat, K., Cl - and CO2. The Electrolyte Reference Reagent is to provide reference points for Nat, K*, Cl and CO, The CO, Acid Reagent is to release CO, from serum and plasma samples and/or librators. The CO, Alkaline Buffer is to provide a constant CO2 concentration as reference for the CO2 * Electrode. The Wash Concentrate is intended to be diluted with de-ionized water. The prepared Wash Solution is used to wash the systems sample probe and to dilute reagents on equivalent Beckman CX® Systems. - ALKO product A443-325 (Electrolyte Buffer) is equivalent to Beckman Instrument product 443325 . (Electrolyte Buffer). - ALKO product A443-315 (Electrolyte Reference Reagent), is equivalent to Beckman Instrument product . 443315 (Electrolyte Reference Reagent). - ALKO product A443-330 (CO2 Acid Reagent), is equivalent to Beckman Instrument product 443330 . (CO2 Acid Reagent). - ALKO product A443-320 (CO2 Alkaline Buffer), is equivalent to Beckman Instrument product 443320 . (CO2 Alkaline Buffer). - ALKO product A443-335 (Wash Concentrate), is equivalent to Beckman Instrument product 443335 . (Wash Concentrate). {1}------------------------------------------------ ALKO uses a similar composition, description and packaging design as that used by Beckman Instrument Inc. in its products. ALKO has shown performance equivalence of its products to Beckman Instrument products in the following manner: - Through a method comparison where results obtained on an equivalent Beckman Chemistry O Analyzer, calibrated with ALKO products and compared with results obtained on the same Analyzer calibrated with Beckman Instrument products; and - Through a precision study where ALKO products were installed on an equivalent Beckman o Chemistry Analyzer and samples were measured one run per day for a defined period as stated below. A summary of the results of these studies follows: ### PERFORMANCE CHARACTERISTICS ### Precision Data Precision data were collected from the analysis of two levels of serum and urine controls, measured in triplicate per run, one run per day for a total of 20 runs over 30 days on the ISE Module of Beckman CX®3, calibrated with all ALKO reagents. | | | N | Mean | STD | CV% | Min | Max | |-----|------------|----|-------|--------|--------|-------|-------| | Na+ | Total | 60 | 137.4 | 1.3186 | 0.9596 | 135.1 | 140.0 | | | Run to Run | 20 | 137.4 | 1.2477 | 0.9080 | 135.5 | 139.7 | | K+ | Total | 60 | 4.17 | 0.0461 | 1.1071 | 4.08 | 4.28 | | | Run to Run | 20 | 4.17 | 0.0430 | 1.0323 | 4.11 | 4.24 | | Cl- | Total | 60 | 100.5 | 1.2705 | 1.2643 | 97.0 | 103.1 | | | Run to Run | 20 | 100.5 | 1.0149 | 1.0099 | 98.5 | 102.3 | | CO2 | Total | 60 | 15.1 | 0.6136 | 4.0549 | 14.1 | 16.6 | | | Run to Run | 20 | 15.1 | 0.5805 | 3.8425 | 14.3 | 16.4 | ### Serum Level : Normal ### Serum Level : Abnormal | | | N | Mean | STD | CV% | Min | Max | |-----|------------|----|-------|--------|--------|-------|-------| | Na+ | Total | 60 | 151.2 | 1.1638 | 0.7698 | 147.5 | 153.1 | | | Run to Run | 20 | 151.2 | 1.0763 | 0.7119 | 148.7 | 152.7 | | K+ | Total | 60 | 7.32 | 0.0620 | 0.8462 | 7.12 | 7.42 | | | Run to Run | 20 | 7.32 | 0.0594 | 0.8120 | 7.14 | 7.40 | | Cl- | Total | 60 | 112.1 | 0.9476 | 0.8451 | 109.6 | 113.9 | | | Run to Run | 20 | 112.1 | 0.8375 | 0.7468 | 110.4 | 113.4 | | CO2 | Total | 60 | 25.5 | 0.4917 | 1.9268 | 24.5 | 26.8 | | | Run to Run | 20 | 25.5 | 0.4393 | 1.7214 | 24.9 | 26.4 | {2}------------------------------------------------ | | | N | Mean | STD | CV% | Min | Max | |-----|------------|----|------|--------|--------|------|------| | Na+ | Total | 60 | 81.0 | 1.0163 | 1.2544 | 79.4 | 83.6 | | | Run to Run | 20 | 81.0 | 0.9591 | 1.1838 | 79.7 | 82.9 | | K+ | Total | 60 | 30.2 | 0.3910 | 1.2944 | 29.3 | 30.9 | | | Run to Run | 20 | 30.2 | 0.3799 | 1.2576 | 29.5 | 30.9 | | Cl- | Total | 60 | 81.3 | 1.1310 | 1.3918 | 78.5 | 83.4 | | | Run to Run | 20 | 81.3 | 0.9046 | 1.1133 | 79.6 | 82.7 | #### Urine Level 2 | | | N | Mean | STD | CV% | Min | Max | |-----|------------|----|-------|--------|--------|-------|-------| | Na+ | Total | 60 | 175.5 | 1.8021 | 1.0267 | 171.8 | 179.6 | | | Run to Run | 20 | 175.5 | 1.7356 | 0.9888 | 172.3 | 179.1 | | K+ | Total | 60 | 100.4 | 1.2619 | 1.2567 | 97.0 | 103.2 | | | Run to Run | 20 | 100.4 | 1.2280 | 1.2229 | 97.1 | 102.9 | | Cl- | Total | 60 | 203.4 | 2.1740 | 1.0690 | 199.5 | 209.0 | | | Run to Run | 20 | 203.4 | 2.0802 | 1.0228 | 200.5 | 208.7 | # Correlation with Beckman Reagents Linear Regression Analyses were performed using the Beckman data as the Independent X Variable and ALKO Data as the Dependent Y Variable in the equation Y = a + bX. #### Serum(Plasma) Samples (Beckman CX®3): Correlation data were collected from 68+ serum and plasma samples for Nat/K+/C1/CO2, measured on the ISE Module of the Beckman CX®3 System, calibrated with ALKO as compared with Beckman reagents separately. | | Na | K | Cl | CO2 | |-----------|-----------|--------|----------|--------| | N | 72 | 74 | 77 | 68 | | Slope | 1.0048 | 0.9840 | 0.9801 | 0.9738 | | Intercept | -0.6344 | 0.0846 | 1.5534 | 0.6117 | | R Squared | 0.9992 | 0.9995 | 0.9991 | 0.9956 | | Range | 100 - 200 | 1 - 15 | 50 - 200 | 5 - 40 | Image /page/2/Picture/9 description: The image shows the text "SHEET 13 OF III" in a bold, sans-serif font. The text appears to be stamped or printed, with some imperfections and variations in ink density. The words are arranged horizontally, with "SHEET" on the left, followed by "13 OF", and then "III" on the right. {3}------------------------------------------------ ## Serum (Plasma) Samples (Beckman CX®5): Correlation data were collected from 34+ serum samples for Na+/K+/Cl-/CO2, measured on the ISE Module of the leckman CX®5 System, calibrated with ALKO as compared with Beckman reagents separately. | | Na | K | Cl | CO2 | |-----------|-----------|--------|----------|--------| | N | 38 | 40 | 34 | 38 | | Slope | 0.9727 | 0.9807 | 0.9369 | 0.9885 | | Intercept | 3.7055 | 0.0447 | 5.0960 | 0.2429 | | R Squared | 0.9961 | 0.9993 | 0.9991 | 0.9988 | | Range | 100 - 200 | 1 - 15 | 50 - 200 | 5 - 40 | ### Urine Samples (Beckman CX®3): Correlation data were collected from 54+ urine samples for Na+/K+/ C1', measured on the ISE Module of the Beckman CX®3 System, calibrated with ALKO as compared with Beckman reagents separately. | | Na | K | Cl | |-----------|----------|---------|----------| | N | 54 | 54 | 55 | | Slope | 0.9984 | 0.9602 | 0.9764 | | Intercept | 0.0968 | 1.0587 | 1.7695 | | R Squared | 0.9997 | 0.9991 | 0.9978 | | Range | 10 - 200 | 2 - 200 | 15 - 300 | I hope you find this information useful and informative. Janet C. Metcalf 7/6/92 (date prepared) Yanet A, McGrath Regulatory Affairs Image /page/3/Picture/11 description: The image shows the text "SHEET 14 OF 11". The text is in a bold, sans-serif font and is black in color. The text is likely part of a document or report, and it indicates that this is sheet 14 of a total of 11 sheets. The text is slightly distorted, possibly due to the image being scanned or photographed. {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines forming the snake and staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the emblem. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 1 1998 SEP Janet A. McGrath . Regulatory Affairs Specialist Alko Diagnostic Corporation 333 Fiske Street 01746 Holliston, Massachusetts K982501 Re : Electrolyte Buffer A443-325, and Reference Reagent Requlatory Class: II Product Code: JIX Dated: July 16, 1998 Received: July 20, 1998 Dear Ms. McGrath: 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, Drug, 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, 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. पै 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 requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. 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. {5}------------------------------------------------ Page 2 Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, 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 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 onthe 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" (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 {6}------------------------------------------------ ### 510(k) Number (if known): ### Device Name: Reagents on Equivalent Beckman Chemistry Analyzers ### Indication For Use: The products encompassed by this request are intended for in vitro diagnostic use and are intended for use in the quantitative determinations of Nat K . Cl . and CO., Beckman Instrument is the Original Equipment Manufacturer of the Chemistry Analyzers and of the predicate Reagents. The Beckman Chemistry Analyzers perform a broad array of tests. ALKO manufactures the ISE Reagents, wherein samples are analyzed for quantitative determinations of Nat, K, Cl and CO2 by ISE method. These Reagents are intended to be used with equivalent Beckman Chemistry Analyzers. As such, ALKO products are intended to serve as direct replacements to like named products manufactured by Beckman Instrument Inc. The Electrolyte Buffer is intended to provide constant ionic strength for measuring electrolytes in the samples. As such, it is diluted with Wash Solution and introduced into the sample and/or calibrator, for quantitative determination of Nat, K*, Cl and CO., The Electrolyte Reference Reagent is intended to provide reference points for Na , K , Cl and CO2. The CO2 Acid Reagent is intended to release CO2 from serum and plasma samples and/or calibrators. The CO, Alkaline Buffer is to provide a constant CO, concentration as reference for the CO, Electrode. The Wash Concentrate is intended to be diluted with deionized water. The prepared Wash Solution is used to wash the systems sample flow path and to dilute reagents on equivalent Beckman CX® Systems. Concurrence of CDRH, Office of Device Evaluation (ODE (Division Sign-Off Division of Clinical Laboratory بارا vice 510(k) Number Prescription Use OR Over-The-Counter Use (Per 21 CFR 801.109) (Optional Format 1-2-96) ( PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Image /page/6/Picture/9 description: The image shows the text "SHEET 16 OF 11". The text is written in a bold, sans-serif font. The numbers "16" and "11" are underlined. The text is likely part of a document or report, indicating the page number or sheet number.