CitriCon Liquid and Powder (Acid Concentrate acidified with Citric Acid), AcetiCon Liquid and Powder (Acid Concentrate acidified with Acetic Acid or Na Di Acetate), BicarboCon Liquid and Powder (Bicarb Concentrate), RenaCon Liquid and Powder (Acetate Concentrate with Na Acetate)
Device Facts
| Record ID | K180679 |
|---|---|
| Device Name | CitriCon Liquid and Powder (Acid Concentrate acidified with Citric Acid), AcetiCon Liquid and Powder (Acid Concentrate acidified with Acetic Acid or Na Di Acetate), BicarboCon Liquid and Powder (Bicarb Concentrate), RenaCon Liquid and Powder (Acetate Concentrate with Na Acetate) |
| Applicant | Global Scientific Technologies, LLC |
| Product Code | KPO · Gastroenterology, Urology |
| Decision Date | Dec 7, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.5820 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
AcetiCon acid concentrate liquids or powders for bicarbonate dialysis are indicated for used in acute and chronic hemodialysis and are accessories to be used with the appropriate hemodialysis machine in a 3 stream mix in the exact prescribed proportion with ANSUAAMI/ISO 13959 standard water for hemodialysis and with bicarbonate concentrate. CitriCon acid concentrate liquids or powders for bicarbonate dialysis are indicated for used in acute and chronic hemodialysis and are accessories to be used with the appropriate hemodialysis machine in a 3 stream mix in the exact prescribed proportion with ANSI/AAMI/ISO 13959 standard water for hemodialysis and with bicarbonate concentrate. BicarboCon bicarbonate concentrate liquids or powders for bicarbonate dialysis are indicated for used in acute and chronic hemodialysis and are accessories to be used with the appropriate hemodialysis machine in the exact proportion with ANSI/AAMI/ISO 13959 standard water for hemodialysis and with acid concentrate. RenaCon acetate concentrate liquids or powders for acetate dialysis are indicated for used in acute and chronic hemodialysis and are accessories to be used with the appropriate hemodialysis machine in a 2 stream mix in the exact prescribed proportion with ANSI/AAMI/ISO 13959 standard water for hemodialysis.
Device Story
Hemodialysis concentrate liquids/powders (AcetiCon, CitriCon, BicarboCon, RenaCon); input: purified water (ANSI/AAMI/ISO 13959) and other concentrates; operation: proportioned/mixed by hemodialysis machines into final dialysis solution; used in clinical settings (acute/chronic hemodialysis); operated by trained healthcare professionals; output: proportioned hemodialysis solution; clinical decision-making: provides electrolyte/buffer balance for patient treatment; benefit: enables effective hemodialysis therapy.
Clinical Evidence
Bench testing only. In vitro testing of laboratory-prepared formulations confirmed component concentrations meet ANSI/AAMI 13958:2014 requirements. Endotoxin testing (LAL test) showed levels < 0.5 EU/ml. Microbial testing for bicarbonate formulations showed levels < 100 CFU/ml.
Technological Characteristics
Liquid/powder concentrates; materials: high-density polyethylene (HDPE) containers, low-density polyethylene (LDPE) bags; sensing/actuation: chemical proportioning via hemodialysis machine; energy: none (passive chemical); connectivity: none; sterilization: N/A (chemical concentrate); standards: AAMI/ANSI/ISO 13958:2014, AAMI/ANSI/ISO 13959:2014.
Indications for Use
Indicated for acute and chronic hemodialysis patients. Used as accessories with hemodialysis machines to prepare dialysis solution via 2-stream or 3-stream mixing with purified water and other concentrates.
Regulatory Classification
Identification
A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient. (2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860). (3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860). (4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.
Predicate Devices
- Solution Technologies (K982378)
- CitraPure Acid Concentrate (K160847, K062399)
- Citrasate Acid Concentrate (K000792)
- Citrisol Acid Concentrate (K130511)
Reference Devices
- Citryte Acid Concentrate (K171015)
- Hemo-Lyte Bicarb Powder (K012328)
- Fresenius Naturalyte Liquid Acid Concentrates (K070177)
- Fresenius Naturalyte Sodium Bicarbonate Liquid Concentrates (K071387)
Related Devices
- K160847 — Rockwell Medical CitraPure Acid Concetrate · Rockwell Medical · Oct 20, 2016
- K990507 — ACID CONCENTRATE AND POWDER, ACETATE CONCENTRATE LIQUID AND POWDER, AND BICARBONATE CONCENTRATE LIQUID AND POWDER · Althin Biopharm, Inc. · May 7, 1999
- K981043 — DIALYSOL-ACID CONCENTRATE LIQUID, GRANUSOL-ACID CONCENTRATE POWDER, RENALSOL-ACETATE CONCENTRATE LIQUID & POWDER, BIOSOL · Solution Technologies · May 26, 1998
- K062399 — ROCKWELL MEDICALTECHNOLOGIES, INC. CITRAPURE · Rockwell Medical Technologies, Inc. · Nov 17, 2006
- K982813 — NATURALYTE, MODEL # 08-4004-1 · Kaybath, Inc. · Nov 6, 1998
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 7, 2018
Global Scientific Technologies, LLC William Griswold, Jr. President P.O Box 1347 Duncan, South Carolina 29334-1347
Re: K180679
Trade/Device Name: CitriCon Liquid and Powder (Acid Concentrate acidified with Citric Acid) AcetiCon Liquid and Powder (Acid Concentrate acidified with either Acetic Acid or Sodium Di Acetate) BicarboCon Liquid and Powder (Bicarbonate Concentrate) RenaCon Liquid and Powder (Acetate Concentrate with Sodium Acetate) Regulation Number: 21 CFR 876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: Class II Product Code: KPO Dated: November 5, 2018 Received: November 7, 2018
Dear William Griswold, Jr.:
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
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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); 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
# Carolyn Y. Neuland -S
for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known)
### K180679
Device Name
AcetiCon Liquid or Powder (Acid Concentrate acidified with either Acetic Acid or Sodium Di Acetate)
### Indications for Use (Describe)
AcetiCon acid concentrate liquids or powders for bicarbonate dialysis are indicated for used in acute and chronic hemodialysis and are accessories to be used with the appropriate hemodialysis machine in a 3 stream mix in the exact prescribed proportion with ANSUAAMI/ISO 13959 standard water for hemodialysis and with bicarbonate concentrate.
| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| <div> <span> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
### CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments reqarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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510(k) Number (if known)
### K180679
Device Name
CitriCon Liquid or Powder (Acid Concentrate acidified with Citric Acid and may be in combination with Sodium Acetate)
### Indications for Use (Describe)
CitriCon acid concentrate liquids or powders for bicarbonate dialysis are indicated for used in acute and chronic hemodialysis and are accessories to be used with the appropriate hemodialysis machine in a 3 stream mix in the exact prescribed proportion with ANSI/AAMI/ISO 13959 standard water for hemodialysis and with bicarbonate concentrate.
| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| <span style="font-family: Arial;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: Arial;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
### CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments reqarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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510(k) Number (if known)
### K180679
Device Name
BicarboCon Liquid or Powder (Bicarbonate Concentrate)
### Indications for Use (Describe)
BicarboCon bicarbonate concentrate liquids or powders for bicarbonate dialysis are indicated for used in acute and chronic hemodialysis and are accessories to be used with the appropriate hemodialysis machine in the exact proportion with ANSI/AAMI/ISO 13959 standard water for hemodialysis and with acid concentrate.
Type of Use (Select one or both, as applicable)
| <div> <span> <b> × </b> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> |
|---------------------------------------------------------------------------------------------------|
| <div> <span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |
### CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments reqarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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510(k) Number (if known)
### K180679
Device Name
RenaCon Liquid or Powder (Acetate Concentrate with Sodium Acetate)
### Indications for Use (Describe)
RenaCon acetate concentrate liquids or powders for acetate dialysis are indicated for used in acute and chronic hemodialysis and are accessories to be used with the appropriate hemodialysis machine in a 2 stream mix in the exact prescribed proportion with ANSI/AAMI/ISO 13959 standard water for hemodialysis.
| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------|----------------------------------------------------------|
| <div><span style="font-family: Arial;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div>☐ Over-The-Counter Use (21 CFR 801 Subpart C)</div> |
### CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments reqarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
004 Indications for Use Statements Rev 1
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This 510(k) summary is in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The content in this 510(k) summary has been provided in conformance with 21 CFR Part 807.92.
# 1. Submitter's Information:
| Company Name: | Global Scientific Technologies, LLC |
|-------------------|-------------------------------------|
| Physical Address: | 151 Old Jones Road |
| City: | Greer |
| State: | South Carolina |
| Zip Code: | 29651 |
| Mailing Address: | P.O. Box 1347 |
| City: | Duncan |
| State: | South Carolina |
| Zip Code: | 29334-1347 |
| Contact Name: | William J. Griswold, Jr. |
| Title: | President |
| Office Phone: | 864-655-3590 |
| Fax: | 877-655-3502 |
| Preparation Date: | March 12, 2018 |
| Revision Date: | November 5, 2018 |
# 2. Device Name (21 CFR 876.5820):
### 2.1. Dialysate Concentrate Solutions for Hemodialysis:
### 2.1.1. Acid Concentrate Liquids & Powders: Trade Name(s): CitriCon & AcetiCon Acid Concentrate Liquids & Powders Common/Usual Name: Dialysate Concentrate for Hemodialysis Classification Name: Class II, Hemodialysis System and Accessories Product Code: KPO: Gastroenterology/Urology
### 2.1.2. Acetate Concentrate Liquids & Powders: Trade Name(s): RenaCon Acetate Concentrate Liquids & Powders Common/Usual Name: Dialysate Concentrate for Hemodialysis Classification Name: Class II, Hemodialysis System and Accessories Product Code: KPO: Gastroenterology/Urology
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- 2.1.3. Bicarbonate Concentrate Liquids & Powders: Trade Name(s): BicarboCon Bicarbonate Concentrate Liquids & Powders Common/Usual Name: Dialysate Concentrate for Hemodialysis Classification Name: Class II, Hemodialysis System and Accessories Product Code: KPO: Gastroenterology/Urology
# 3. Predicate Device Names:
- 3.1. Solution Technologies K982378 (PRIMARY PREDICATE)
- 3.1.1. Device Names: Hemosol, Hemogran, Nephrosol, Nephrogran, Bicarbosol and Bicarbogran Dialysate Concentrate
- 3.2. Rockwell Medical Technologies. Inc K160847 & K062399 (SECONDARY PREDICATE) 3.2.1. Device Name: CitraPure Acid Concentrate
- 3.3. Advanced Renal Technologies, Inc K000792 (SECONDARY PREDICATE) 3.3.1. Device Name: Citrasate Acid Concentrate
- 3.4. Diasol, Inc. K130511 (SECONDARY PREDICATE) 3.4.1. Device Name: Citrisol Acid Concentrate
- 3.5. Di-Chem, Inc. K171015 (REFERENCE DEVICE) 3.5.1. Device Name: Citryte Acid Concentrate
- 3.6. Di-Chem, Inc. K012328 (REFERENCE DEVICE) 3.6.1. Device Name: Hemo-Lyte Bicarb Powder
- 3.7. Fresenius Medical Care North America K070177 (REFERENCE DEVICE) 3.7.1. Fresenius Naturalyte Liquid Acid Concentrates, 9000, 6000 and 4000 Series
- 3.8. Fresenius Medical Care North America K071387 (REFERENCE DEVICE) 3.8.1. Fresenius Naturalyte Sodium Bicarbonate Liquid Concentrates, 4000 Series
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# Global Scientific Technologies, LLC AcetiCon, CitriCon, BicarboCon & RenaCon for Hemodialysis (Liquids & Powders) Traditional 510(k) Premarket Notification 510(k) SUMMARY UNDER 21 CFR 807.92 4. Device Description / Indications for Use:
- 4.1. CitriCon and AcetiCon Liquid and Powder Acid Concentrates and BicarboCon Liquid and Powder Bicarbonate Concentrates:
- 4.1.1. Device Description All liquid and powder acid and bicarbonate concentrates for bicarbonate dialysis presented in this 510(k) Notification are produced in a manner consistence with the predicate devices listed in Section 3 of this 510(k) Summary by adhering to strict cGMP guidelines and in accordance with AAMI/ANSI/ISO 13958:2014 Concentrates for Hemodialysis and Related Therapies and AAMI/ANSI/ISO 13959:2014 Water for Hemodialysis and Related Therapies. CitriCon liquids and powders contain Citric Acid and may contain Sodium Acetate along with various other ingredients (such as sodium chloride, calcium chloride, potassium chloride, magnesium chloride and dextrose, all meeting or exceeding current AAMI standards for purity) are equivalent to currently marketed acid concentrates for bicarbonate dialysis. AcetiCon liquids and powders contain either Acetic Acid or Sodium DiAcetate along with various other ingredients (such as sodium chloride, calcium chloride, potassium chloride, magnesium chloride and dextrose, all meeting or exceeding current AAMI standards for purity) are equivalent to currently marketed acid concentrates for bicarbonate dialysis. BicarboCon liquids and powders contain Sodium Bicarbonate and may contain Sodium Chloride, (both either meeting or exceeding current AAMI standards for purity) are equivalent to currently marketed bicarbonate concentrates for bicarbonate dialysis. These products are not designed and/or formulated for reuse and should be considered as single-use only. These acid and bicarbonate concentrate liquid and powder formulations when proportioned/mixed with pretreated, purified water that meets or exceeds current AAMI standards may be used with conventional and commercially available hemodialysis machines or monitors as a hemodialysis solution. These hemodialysis concentrates are intended to be used in three stream hemodialysis machine in which an acidified concentrate is proportioned into one stream, a bicarbonate concentrate is proportioned into a second stream and a third stream of water that meets or exceeds current AAMI standards. Where these three streams are then mixed to prepare a final proportioned hemodialysis solution.
| Criteria | Description/Specification |
|---------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Component Formula<br>Range<br>*Acetate is derived from<br>either Acetic Acid or<br>Sodium DiAcetate<br>individually. Not in<br>combination. | Sodium 70 – 110 mEq/L<br>Potassium 0 – 5 mEq/L<br>Calcium 0 – 5 mEq/L<br>Magnesium 0 – 2 mEq/L<br>Dextrose 0 – 350 mg/dl (mg %)<br>*Acetate from Acetic Acid 2 – 5 mEq/L<br>*Acetate from Sodium DiAcetate 4 – 8 mEq/L |
| Physical State | Liquid - packaged in Polyethylene (PE) containers<br>Powder - packaged in Polyethylene (PE) containers |
| Proportioning Ratios<br>(AcetiCon : Water) | 1:34 (35X), 1:35.83 (36.83X), and 1:44 (45X) |
### 4.1.2. Summary of Concentrate Ranges:
### 4.1.2.1. AcetiCon Concentrates - Summary of Ranges:
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# Global Scientific Technologies, LLC
# AcetiCon, CitriCon, BicarboCon & RenaCon for Hemodialysis (Liquids & Powders) Traditional 510(k) Premarket Notification 510(k) SUMMARY UNDER 21 CFR 807.92
### AcetiCon Concentrate Formulas: 4.1.2.1.1.
The following lists of formulas for AcetiCon Concentrates, which are intend to market upon acceptance of this 510(k) submission, represent the most popular formulas within the component ranges submitted. Note: Any future new formulas within the approved ranges that are not listed herein will be documented using design controls and the design records will be maintained in the company's design history files.
| Prod. | Na+ | K+ | Ca++ | Mg++ | Dextrose | Acetic | Sodium<br>DiAcetate |
|-------------------------------------------------------------------------------------------------|------------------------|--------------------|----------------------|----------------------|---------------------------|--------------------------------|-------------------------------------|
| Code | 70-110<br>mEq/L | 0-5<br>mEq/L | 0-5<br>mEq/L | 0-2<br>mEq/L | 0-350<br>mg % | Acid<br>2-5<br>mEq/L | 4-8<br>mEq/L |
| AC1000 | 79.00 | 2.00 | 3.50 | 1.50 | 0.00 | 4.00 | |
| DA6000 | 79.00 | 2.00 | 3.50 | 1.50 | 0.00 | | 8.00 |
| AC1001 | 80.00 | 0.00 | 3.50 | 1.00 | 200.00 | 4.00 | |
| DA6001 | 80.00 | 0.00 | 3.50 | 1.00 | 200.00 | | 8.00 |
| AC1003 | 80.00 | 2.00 | 3.50 | 1.00 | 200.00 | 4.00 | |
| DA6003 | 80.00 | 2.00 | 3.50 | 1.00 | 200.00 | | 8.00 |
| AC1004 | 79.00 | 2.00 | 3.50 | 1.50 | 200.00 | 4.00 | |
| DA6004 | 79.00 | 2.00 | 3.50 | 1.50 | 200.00 | | 8.00 |
| AC1006 | 79.00 | 2.00 | 2.50 | 1.50 | 100.00 | 4.00 | |
| DA6006 | 79.00 | 2.00 | 2.50 | 1.50 | 100.00 | | 8.00 |
| AC1007 | 80.00 | 2.00 | 2.00 | 1.50 | 200.00 | 4.00 | |
| DA6007 | 80.00 | 2.00 | 2.00 | 1.50 | 200.00 | | 8.00 |
| AC1008 | 80.00 | 2.50 | 3.50 | 1.00 | 150.00 | 4.00 | |
| DA6008 | 80.00 | 2.50 | 3.50 | 1.00 | 150.00 | | 8.00 |
| AC1009 | 80.00 | 3.00 | 3.50 | 1.00 | 200.00 | 4.00 | |
| DA6009 | 80.00 | 3.00 | 3.50 | 1.00 | 200.00 | | 8.00 |
| AC1015 | 80.00 | 2.00 | 2.50 | 1.00 | 200.00 | 4.00 | |
| DA6015 | 80.00 | 2.00 | 2.50 | 1.00 | 200.00 | | 8.00 |
| AC1016 | 80.00 | 0.00 | 3.00 | 1.00 | 200.00 | 4.00 | |
| DA6016 | 80.00 | 0.00 | 3.00 | 1.00 | 200.00 | | 8.00 |
| AC1017 | 80.00 | 2.00 | 2.20 | 1.50 | 200.00 | 4.00 | |
| DA6017 | 80.00 | 2.00 | 2.20 | 1.50 | 200.00 | | 8.00 |
| AC1018 | 80.00 | 1.00 | 3.00 | 1.00 | 250.00 | 4.00 | |
| DA6018 | 80.00 | 1.00 | 3.00 | 1.00 | 250.00 | | 8.00 |
| AC1019 | 79.00 | 0.00 | 3.50 | 1.50 | 0.00 | 4.00 | |
| DA6019 | 79.00 | 0.00 | 3.50 | 1.50 | 0.00 | | 8.00 |
| AC1021 | 81.00 | 2.50 | 2.50 | 1.00 | 200.00 | 4.00 | |
| DA6021 | 81.00 | 2.50 | 2.50 | 1.00 | 200.00 | | 8.00 |
| AC1025 | 81.00 | 2.00 | 3.25 | 0.50 | 0.00 | 4.00 | |
| DA6025 | 81.00 | 2.00 | 3.25 | 0.50 | 0.00 | | 8.00 |
| AC1026 | 81.00 | 2.00 | 0.00 | 1.00 | 100.00 | 4.00 | |
| DA6026 | 81.00 | 2.00 | 0.00 | 1.00 | 100.00 | | 8.00 |
| 510(k) SUMMARY UNDER 21 CFR 807.92<br>Continuation of 4.1.2.1.1 AcetiCon Concentrate Formulas | | | | | | | |
| Prod. Code | Na+<br>70-110<br>mEq/L | K+<br>0-5<br>mEq/L | Ca++<br>0-5<br>mEq/L | Mg++<br>0-2<br>mEq/L | Dextrose<br>0-350<br>mg % | Acetic<br>Acid<br>2-5<br>mEq/L | Sodium<br>DiAcetate<br>4-8<br>mEq/L |
| AC1027 | 81.00 | 2.00 | 2.00 | 1.00 | 200.00 | 4.00 | |
| DA6027 | 81.00 | 2.00 | 2.00 | 1.00 | 200.00 | | 8.00 |
| AC1029 | 81.00 | 2.00 | 2.50 | 1.00 | 200.00 | 4.00 | |
| DA6029 | 81.00 | 2.00 | 2.50 | 1.00 | 200.00 | | 8.00 |
| AC1030 | 81.00 | 0.00 | 2.50 | 1.00 | 200.00 | 4.00 | |
| DA6030 | 81.00 | 0.00 | 2.50 | 1.00 | 200.00 | | 8.00 |
| AC1031 | 81.00 | 2.00 | 3.00 | 1.00 | 200.00 | 4.00 | |
| DA6031 | 81.00 | 2.00 | 3.00 | 1.00 | 200.00 | | 8.00 |
| AC1032 | 84.00 | 2.00 | 3.25 | 1.00 | 200.00 | 4.00 | |
| DA6032 | 84.00 | 2.00 | 3.25 | 1.00 | 200.00 | | 8.00 |
| AC1033 | 84.00 | 1.00 | 2.50 | 1.00 | 200.00 | 4.00 | |
| DA6033 | 84.00 | 1.00 | 2.50 | 1.00 | 200.00 | | 8.00 |
| AC1035 | 81.00 | 2.00 | 1.50 | 1.00 | 200.00 | 4.00 | |
| DA6035 | 81.00 | 2.00 | 1.50 | 1.00 | 200.00 | | 8.00 |
| AC1036 | 81.00 | 3.00 | 2.50 | 0.50 | 100.00 | 4.00 | |
| DA6036 | 81.00 | 3.00 | 2.50 | 0.50 | 100.00 | | 8.00 |
| AC1037 | 81.00 | 2.00 | 2.50 | 0.50 | 100.00 | 4.00 | |
| DA6037 | 81.00 | 2.00 | 2.50 | 0.50 | 100.00 | | 8.00 |
| AC1038 | 80.00 | 3.00 | 3.00 | 1.00 | 200.00 | 4.00 | |
| DA6038 | 80.00 | 3.00 | 3.00 | 1.00 | 200.00 | | 8.00 |
| AC1039 | 80.00 | 0.00 | 2.50 | 0.50 | 200.00 | 4.00 | |
| DA6039 | 80.00 | 0.00 | 2.50 | 0.50 | 200.00 | | 8.00 |
| AC1040 | 80.00 | 2.00 | 2.50 | 0.50 | 200.00 | 4.00 | |
| DA6040 | 80.00 | 2.00 | 2.50 | 0.50 | 200.00 | | 8.00 |
| AC1041 | 77.00 | 3.00 | 2.50 | 0.50 | 200.00 | 4.00 | |
| DA6041 | 77.00 | 3.00 | 2.50 | 0.50 | 200.00 | | 8.00 |
| AC1042 | 80.00 | 2.00 | 3.00 | 1.00 | 200.00 | 4.00 | |
| DA6042 | 80.00 | 2.00 | 3.00 | 1.00 | 200.00 | | 8.00 |
| AC1047 | 80.00 | 1.00 | 3.50 | 1.00 | 200.00 | 4.00 | |
| DA6047 | 80.00 | 1.00 | 3.50 | 1.00 | 200.00 | | 8.00 |
| AC1048 | 80.00 | 3.00 | 2.00 | 1.00 | 200.00 | 4.00 | |
| DA6048 | 80.00 | 3.00 | 2.00 | 1.00 | 200.00 | | 8.00 |
| AC1049 | 80.00 | 1.00 | 2.00 | 1.50 | 200.00 | 4.00 | |
| DA6049 | 80.00 | 1.00 | 2.00 | 1.50 | 200.00 | | 8.00 |
| AC1050 | 84.00 | 1.00 | 3.00 | 1.00 | 200.00 | 4.00 | |
| DA6050 | 84.00 | 1.00 | 3.00 | 1.00 | 200.00 | | 8.00 |
| AC1051 | 81.00 | 1.00 | 2.50 | 1.00 | 200.00 | 4.00 | |
| 510(k) SUMMARY UNDER 21 CFR 807.92 | | | | | | | |
| Continuation of 4.1.2.1.1 AcetiCon Concentrate Formulas | | | | | | | |
| Prod.<br>Code | Na+<br>70-110<br>mEq/L | K+<br>0-5<br>mEq/L | Ca++<br>0-5<br>mEq/L | Mg++<br>0-2<br>mEq/L | Dextrose<br>0-350<br>mg % | Acetic<br>Acid<br>2-5<br>mEq/L | Sodium<br>DiAcetate<br>4-8<br>mEq/L |
| DA6051 | 81.00 | 1.00 | 2.50 | 1.00 | 200.00 | | 8.00 |
| AC1052 | 81.00 | 1.00 | 2.50 | 0.70 | 200.00 | 4.00 | |
| DA6052 | 81.00 | 1.00 | 2.50 | 0.70 | 200.00 | | 8.00 |
| AC1053 | 81.00 | 0.00 | 0.00 | 1.00 | 200.00 | 4.00 | |
| DA6053 | 81.00 | 0.00 | 0.00 | 1.00 | 200.00 | | 8.00 |
| AC1054 | 80.00 | 4.00 | 3.50 | 1.50 | 200.00 | 4.00 | |
| DA6054 | 80.00 | 4.00 | 3.50 | 1.50 | 200.00 | | 8.00 |
| AC1055 | 83.00 | 0.00 | 0.00 | 1.00 | 200.00 | 4.00 | |
| DA6055 | 83.00 | 0.00 | 0.00 | 1.00 | 200.00 | | 8.00 |
| AC1056 | 84.00 | 3.00 | 3.25 | 1.00 | 200.00 | 4.00 | |
| DA6056 | 84.00 | 3.00 | 3.25 | 1.00 | 200.00 | | 8.00 |
| AC1057 | 84.00 | 2.00 | 1.00 | 1.00 | 200.00 | 4.00 | |
| DA6057 | 84.00 | 2.00 | 1.00 | 1.00 | 200.00 | | 8.00 |
| AC1058 | 84.00 | 0.00 | 3.25 | 1.00 | 200.00 | 4.00 | |
| DA6058 | 84.00 | 0.00 | 3.25 | 1.00 | 200.00 | | 8.00 |
| AC1059 | 81.00 | 3.00 | 2.50 | 0.75 | 200.00 | 4.00 | |
| DA6059 | 81.00 | 3.00 | 2.50 | 0.75 | 200.00 | | 8.00 |
| AC1060 | 83.00 | 3.00 | 2.50 | 1.00 | 200.00 | 4.00 | |
| DA6060 | 83.00 | 3.00 | 2.50 | 1.00 | 200.00 | | 8.00 |
| AC1061 | 80.00 | 3.00 | 2.50 | 0.75 | 200.00 | 4.00 | |
| DA6061 | 80.00 | 3.00 | 2.50 | 0.75 | 200.00 | | 8.00 |
| AC1062 | 81.00 | 1.00 | 3.00 | 1.00 | 200.00 | 4.00 | |
| DA6062 | 81.00 | 1.00 | 3.00 | 1.00 | 200.00 | | 8.00 |
| AC1063 | 70.00 | 1.00 | 5.00 | 0.00 | 200.00 | 2.00 | |
| DA6063 | 70.00 | 1.00 | 5.00 | 0.00 | 200.00 | | 4.00 |
| AC1064 | 80.00 | 5.00 | 1.00 | 2.00 | 350.00 | 5.00 | |
| DA6064 | 80.00 | 5.00 | 1.00 | 2.00 | 350.00 | | 8.00 |
| AC2000 | 100.00 | 2.00 | 3.00 | 0.75 | 0.00 | 4.00 | |
| DA7000 | 100.00 | 2.00 | 3.00 | 0.75 | 0.00 | | 8.00 |
| AC2001 | 100.00 | 2.00 | 3.00 | 0.75 | 200.00 | 4.00 | |
| DA7001 | 100.00 | 2.00 | 3.00 | 0.75 | 200.00 | | 8.00 |
| AC2002 | 100.00 | 0.00 | 3.00 | 0.75 | 200.00 | 4.00 | |
| DA7002 | 100.00 | 0.00 | 3.00 | 0.75 | 200.00 | | 8.00 |
| AC2003 | 100.00 | 3.00 | 3.00 | 0.75 | 200.00 | 4.00 | |
| DA7003 | 100.00 | 3.00 | 3.00 | 0.75 | 200.00 | | 8.00 |
| AC2006 | 100.00 | 1.00 | 3.00 | 0.75 | 200.00 | 4.00 | |
| | | | | | | | |
| DA7006 | 100.00 | 1.00 | 3.00 | 0.75 | 200.00 | | 8.00 |
| Continuation of 4.1.2.1.1 AcetiCon Concentrate Formulas | | | | | | | |
| Prod. Code | Na+<br>70-110<br>mEq/L | K+<br>0-5<br>mEq/L | Ca++<br>0-5<br>mEq/L | Mg++<br>0-2<br>mEq/L | Dextrose<br>0-350<br>mg % | Acetic<br>Acid<br>2-5<br>mEq/L | Sodium<br>DiAcetate<br>4-8<br>mEq/L |
| AC2007 | 100.00 | 2.00 | 0.00 | 0.75 | 200.00 | 4.00 | |
| DA7007 | 100.00 | 2.00 | 0.00 | 0.75 | 200.00 | | 8.00 |
| AC2008 | 100.00 | 0.00 | 2.50 | 0.75 | 200.00 | 4.00 | |
| DA7008 | 100.00 | 0.00 | 2.50 | 0.75 | 200.00 | | 8.00 |
| AC2011 | 100.00 | 1.00 | 0.00 | 0.75 | 200.00 | 4.00 | |
| DA7011 | 100.00 | 1.00 | 0.00 | 0.75 | 200.00 | | 8.00 |
| AC2013 | 100.00 | 1.00 | 3.00 | 1.00 | 200.00 | 4.00 | |
| DA7013 | 100.00 | 1.00 | 3.00 | 1.00 | 200.00 | | 8.00 |
| AC2017 | 100.00 | 2.00 | 2.00 | 0.75 | 200.00 | 4.00 | |
| DA7017 | 100.00 | 2.00 | 2.00 | 0.75 | 200.00 | | 8.00 |
| AC2018 | 100.00 | 1.00 | 2.50 | 0.75 | 200.00 | 4.00 | |
| DA7018 | 100.00 | 1.00 | 2.50 | 0.75 | 200.00 | | 8.00 |
| AC2019 | 100.00 | 2.00 | 2.50 | 0.75 | 200.00 | 4.00 | |
| DA7019 | 100.00 | 2.00 | 2.50 | 0.75 | 200.00 | | 8.00 |
| AC2020 | 100.00 | 2.00 | 0.00 | 1.00 | 100.00 | 4.00 | |
| DA7020 | 100.00 | 2.00 | 0.00 | 1.00 | 100.00 | | 8.00 |
| AC2021 | 100.00 | 1.00 | 2.00 | 1.00 | 200.00 | 4.00 | |
| DA7021 | 100.00 | 1.00 | 2.00 | 1.00 | 200.00 | | 8.00 |
| AC2022 | 100.00 | 2.00 | 3.25 | 0.50 | 100.00 | 4.00 | |
| DA7022 | 100.00 | 2.00 | 3.25 | 0.50 | 100.00 | | 8.00 |
| AC2023 | 100.00 | 3.00 | 2.00 | 0.75 | 200.00 | 4.00 | |
| DA7023 | 100.00 | 3.00 | 2.00 | 0.75 | 200.00 | | 8.00 |
| AC2024 | 100.00 | 4.00 | 3.00 | 0.75 | 200.00 | 4.00 | |
| DA7024 | 100.00 | 4.00 | 3.00 | 0.75 | 200.00 | | 8.00 |
| AC2025 | 100.00 | 1.50 | 2.50 | 0.75 | 200.00 | 4.00 | |
| DA7025 | 100.00 | 1.50 | 2.50 | 0.75 | 200.00 | | 8.00 |
| AC2026 | 100.00 | 3.00 | 2.50 | 0.75 | 200.00 | 4.00 | |
| DA7026 | 100.00 | 3.00 | 2.50 | 0.75 | 200.00 | | 8.00 |
| AC2027 | 100.00 | 0.00 | 0.00 | 0.75 | 200.00 | 4.00 | |
| DA7027 | 100.00 | 0.00 | 0.00 | 0.75 | 200.00 | | 8.00 |
| AC3000 | 103.00 | 3.00 | 3.50 | 1.00 | 200.00 | 3.00 | |
| DA8000 | 103.00 | 3.00 | 3.50 | 1.00 | 200.00 | | 6.00 |
| AC3001 | 103.00 | 2.00 | 3.50 | 1.00 | 100.00 | 3.00 | |
| DA8001 | 103.00 | 2.00 | 3.50 | 1.00 | 100.00 | | 6.00 |
| AC3002 | 103.00 | 0.00 | 3.50 | 1.00 | 100.00 | 3.00 | |
| DA8002 | 103.00 | 0.00 | 3.50 | 1.00 | 100.00 | | 6.00 |
| 510(k) SUMMARY UNDER 21 CFR 807.92 | | | | | | | |
| AC3003 | 103.00 | 2.00 | 3.50 | 0.00 | 200.00 | 3.00 | |
| Continuation of 4.1.2.1.1 AcetiCon Concentrate Formulas | | | | | | | |
| Prod.<br>Code | Na+<br>70-110<br>mEq/L | K+<br>0-5<br>mEq/L | Ca++<br>0-5<br>mEq/L | Mg++<br>0-2<br>mEq/L | Dextrose<br>0-350<br>mg % | Acetic<br>Acid<br>2-5<br>mEq/L | Sodium<br>DiAcetate<br>4-8<br>mEq/L |
| DA8003 | 103.00 | 2.00 | 3.50 | 0.00 | 200.00 | | 6.00 |
| AC3004 | 103.00 | 1.00 | 3.50 | 1.00 | 200.00 | 3.00 | |
| DA8004 | 103.00 | 1.00 | 3.50 | 1.00 | 200.00 | | 6.00 |
| AC3005 | 103.00 | 2.00 | 0.00 | 1.00 | 100.00 | 3.00 | |
| DA8005 | 103.00 | 2.00 | 0.00 | 1.00 | 100.00 | | 6.00 |
| AC3006 | 103.00 | 2.00 | 3.50 | 1.00 | 200.00 | 3.00 | |
| DA8006 | 103.00 | 2.00 | 3.50 | 1.00 | 200.00 | | 6.00 |
| AC3007 | 103.00 | 2.00 | 3.00 | 1.00 | 200.00 | 3.00 | |
| DA8007 | 103.00 | 2.00 | 3.00 | 1.00 | 200.00 | | 6.00 |
| AC3008 | 103.00 | 3.00 | 3.00 | 1.00 | 200.00 | 3.00 | |
| DA8008 | 103.00 | 3.00 | 3.00 | 1.00 | 200.00 | | 6.00 |
| AC3009 | 103.00 | 0.00 | 3.00 | 1.00 | 200.00 | 3.00 | |
| DA8009 | 103.00 | 0.00 | 3.00 | 1.00 | 200.00 | | 6.00 |
| AC3010 | 103.00 | 2.00 | 1.00 | 1.00 | 200.00 | 3.00 | |
| DA8010 | 103.00 | 2.00 | 1.00 | 1.00 | 200.00 | | 6.00 |
| AC3011 | 104.00 | 2.00 | 2.50 | 1.00 | 200.00 | 3.00 | |
| DA8011 | 104.00 | 2.00 | 2.50 | 1.00 | 200.00 | | 6.00 |
| AC3012 | 103.00 | 2.00 | 2.00 | 1.00 | 200.00 | 3.00 | |
| DA8012 | 103.00 | 2.00 | 2.00 | 1.00 | 200.00 | | 6.00 |
| AC3013 | 103.00 | 1.00 | 2.50 | 1.00 | 200.00 | 3.00 | |
| DA8013 | 103.00 | 1.00 | 2.50 | 1.00 | 200.00 | | 6.00 |
| AC3014 | 103.00 | 2.00 | 2.50 | 0.75 | 100.00 | 3.00 | |
| DA8014 | 103.00 | 2.00 | 2.50 | 0.75 | 100.00 | | 6.00 |
| AC3015 | 103.00 | 2.00 | 3.00 | 1.00 | 100.00 | 3.00 | |
| DA8015 | 103.00 | 2.00 | 3.00 | 1.00 | 100.00 | | 6.00 |
| AC3016 | 103.00 | 2.00 | 2.50 | 0.75 | 200.00 | 3.00 | |
| DA8016 | 103.00 | 2.00 | 2.50 | 0.75 | 200.00 | | 6.00 |
| AC3017 | 110.00 | 2.00 | 2.50 | 1.00 | 350.00 | 3.00 | |
| DA8017 | 110.00 | 2.00 | 2.50 | 1.00 | 350.00 | | 6.00 |
| AC1XXX & DA6XXX series product code values are based on a proportion ratio of 1:35.83 (36.83X). | | | | | | | |
{10}------------------------------------------------
{11}------------------------------------------------
{12}------------------------------------------------
{13}------------------------------------------------
AC3XXX & DA8XXX series product code values are based on a proportion ratio of 1:34 (35X).
{14}------------------------------------------------
#### CitriCon Concentrates Summary of Ranges: 4.1.2.2
| Criteria | Description/Specification |
|---------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Component Formula<br>Range | Sodium 70 – 110 mEq/L<br>Potassium 0 – 5 mEq/L<br>Calcium 2 – 5 mEq/L<br>Magnesium 0 – 2 mEq/L<br>Dextrose 0 – 350 mg/dl (mg %) |
| *Citrate is derived from<br>Citric Acid and acetate is<br>derived from Sodium<br>Acetate (which may be<br>used in combination). | *Citric Acid 2.4 mEq/L<br>*Sodium Acetate 0 – 0.3 mEq/L |
| Physical State | Liquid - packaged in Polyethylene (PE) containers<br>Powder - packaged in Polyethylene (PE) containers |
| Proportioning Ratios<br>(CitriCon : Water) | 1:34 (35X), 1:35.83 (36.83X), and 1:44 (45X) |
### 4.1.2.2.1. CitriCon Concentrate Formulas:
The following lists of formulas for CitriCon Concentrates, which are intend to market upon acceptance of this 510(k) submission, represent the most popular formulas within the component ranges submitted. Note: Any future new formulas within the approved ranges that are not listed herein will be documented using design controls and the design records will be maintained in the company's design history files.
| Prod. | Na+ | K+ | Ca++ | Mg++ | Dextrose | Citric | Sodium |
|-----------------------------------------------------------------------------------------------|------------------------|--------------------|----------------------|----------------------|---------------------------|-----------------------------|----------------------------------|
| Code | 70-110 | 0-5 | 2-5 | 0-2 | 0-350 | Acid | Acetate |
| | mEq/L | mEq/L | mEq/L | mEq/L | mg % | 2.4 mEq/L | 0-0.3 mEq/L |
| CC1000 | 79.00 | 2.00 | 3.50 | 1.50 | 0.00 | 2.40 | 0.00 |
| CC1001 | 80.00 | 0.00 | 3.50 | 1.00 | 200.00 | 2.40 | 0.00 |
| CC1003…
