(43 days)
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No
The document describes in vitro diagnostic reagents for use with existing chemistry analyzers. There is no mention of any computational analysis, algorithms, or learning processes that would indicate the use of AI or ML. The focus is on the chemical composition and performance of the reagents themselves.
No
Explanation: The device is intended for in vitro diagnostic use, specifically for the quantitative determination of Nat, K, Cl, and CO2 in samples for diagnostic purposes, not for direct therapeutic intervention.
Yes
The document explicitly states that the products are "intended for in vitro diagnostic use" and are used for "quantitative determinations of Na, K, Cl, and CO2," which are diagnostic measurements for patient samples.
No
The device described is a set of in vitro diagnostic reagents (solutions) intended for use with chemistry analyzers. These are physical chemical substances, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The document explicitly states in the "Intended Use / Indications for Use" section: "The products encompassed by this request are intended for in vitro diagnostic use..."
- Purpose: The reagents are intended for the "quantitative determinations of Nat K . Cl . and CO." in samples like serum, plasma, and urine. This is a diagnostic purpose, providing information about a patient's health status.
- Method: The analysis is performed "by ISE method" on "equivalent Beckman Chemistry Analyzers." This indicates the testing is done outside of the living body (in vitro) using laboratory equipment.
- Classification: The "Device Description" section states the products are "Class II (75JIX) In Vitro Diagnostic Solutions".
All of these points clearly indicate that the device falls under the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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 Analyzers 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.
Product codes (comma separated list FDA assigned to the subject device)
75JIX
Device Description
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 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.
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).
ALKO uses a similar composition, description and packaging design as that used by Beckman Instrument Inc. in its products.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
For Serum Level: Normal (N=60 for Total, N=20 for Run to Run):
Na+: Mean 137.4, STD 1.3186, CV% 0.9596 (Total); Mean 137.4, STD 1.2477, CV% 0.9080 (Run to Run)
K+: Mean 4.17, STD 0.0461, CV% 1.1071 (Total); Mean 4.17, STD 0.0430, CV% 1.0323 (Run to Run)
Cl-: Mean 100.5, STD 1.2705, CV% 1.2643 (Total); Mean 100.5, STD 1.0149, CV% 1.0099 (Run to Run)
CO2: Mean 15.1, STD 0.6136, CV% 4.0549 (Total); Mean 15.1, STD 0.5805, CV% 3.8425 (Run to Run)
For Serum Level: Abnormal (N=60 for Total, N=20 for Run to Run):
Na+: Mean 151.2, STD 1.1638, CV% 0.7698 (Total); Mean 151.2, STD 1.0763, CV% 0.7119 (Run to Run)
K+: Mean 7.32, STD 0.0620, CV% 0.8462 (Total); Mean 7.32, STD 0.0594, CV% 0.8120 (Run to Run)
Cl-: Mean 112.1, STD 0.9476, CV% 0.8451 (Total); Mean 112.1, STD 0.8375, CV% 0.7468 (Run to Run)
CO2: Mean 25.5, STD 0.4917, CV% 1.9268 (Total); Mean 25.5, STD 0.4393, CV% 1.7214 (Run to Run)
For Urine Level 1 (N=60 for Total, N=20 for Run to Run):
Na+: Mean 81.0, STD 1.0163, CV% 1.2544 (Total); Mean 81.0, STD 0.9591, CV% 1.1838 (Run to Run)
K+: Mean 30.2, STD 0.3910, CV% 1.2944 (Total); Mean 30.2, STD 0.3799, CV% 1.2576 (Run to Run)
Cl-: Mean 81.3, STD 1.1310, CV% 1.3918 (Total); Mean 81.3, STD 0.9046, CV% 1.1133 (Run to Run)
For Urine Level 2 (N=60 for Total, N=20 for Run to Run):
Na+: Mean 175.5, STD 1.8021, CV% 1.0267 (Total); Mean 175.5, STD 1.7356, CV% 0.9888 (Run to Run)
K+: Mean 100.4, STD 1.2619, CV% 1.2567 (Total); Mean 100.4, STD 1.2280, CV% 1.2229 (Run to Run)
Cl-: Mean 203.4, STD 2.1740, CV% 1.0690 (Total); Mean 203.4, STD 2.0802, CV% 1.0228 (Run to Run)
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+: N=72, Slope=1.0048, Intercept=-0.6344, R Squared=0.9992, Range=100 - 200
K+: N=74, Slope=0.9840, Intercept=0.0846, R Squared=0.9995, Range=1 - 15
Cl-: N=77, Slope=0.9801, Intercept=1.5534, R Squared=0.9991, Range=50 - 200
CO2: N=68, Slope=0.9738, Intercept=0.6117, R Squared=0.9956, Range=5 - 40
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+: N=38, Slope=0.9727, Intercept=3.7055, R Squared=0.9961, Range=100 - 200
K+: N=40, Slope=0.9807, Intercept=0.0447, R Squared=0.9993, Range=1 - 15
Cl-: N=34, Slope=0.9369, Intercept=5.0960, R Squared=0.9991, Range=50 - 200
CO2: N=38, Slope=0.9885, Intercept=0.2429, R Squared=0.9988, Range=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+: N=54, Slope=0.9984, Intercept=0.0968, R Squared=0.9997, Range=10 - 200
K+: N=54, Slope=0.9602, Intercept=1.0587, R Squared=0.9991, Range=2 - 200
Cl-: N=55, Slope=0.9764, Intercept=1.7695, R Squared=0.9978, Range=15 - 300
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(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 the limitations in § 862.9.
0
SEP 1998
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 |
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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
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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.
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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)
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