(49 days)
Multichem S Plus / S Plus (Assayed) control are intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
The use of quality control material is indicated as an objective assessment of the precision of methods and techniques and is an integral part of good laboratory practices. Three levels of control are available to allow performance monitoring within the analytical range. There is no difference in the formulation or manufacturing procedure between Multichem S Plus and Multichem S Plus (Assayed). Both are multi-analyte assayed QC materials with the same formula; however, there is a difference only in the product claims that are published to the users.
The provided 510(k) summary (K132751) describes the Multichem S Plus / S Plus (Assayed) control product, which is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures. As a quality control material, the "device" itself is designed to provide known values for various analytes, which are then used by laboratories to ensure the accuracy and precision of their analytical instruments and methods. The studies described are primarily focused on establishing the stability and value assignments of this control material, rather than on proving its diagnostic accuracy or comparative effectiveness in a clinical setting like an AI algorithm would.
Therefore, many of the typical acceptance criteria and study aspects you've asked for, such as "effect size of how much human readers improve with AI vs without AI assistance" or "adjudication method for the test set," are not applicable to this type of device. This submission focuses on the analytical performance (stability and value assignment) of a quality control product.
Here's an attempt to answer the questions based on the provided text, noting where specific questions are not applicable:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the format of pass/fail thresholds for specific performance metrics in a single table. Instead, it describes the methodology for establishing value assignment ranges and evaluating stability.
| Performance Characteristic | Acceptance Criteria (Implied/Method) | Reported Device Performance |
|---|---|---|
| Value Assignment | Pre-determined criteria of 20% around the grand mean (expanded to 30% or as needed). 10% range for Potassium, Sodium, and Chloride. | Value assignment ranges were established utilizing internal procedures and protocols, with 2 reagent lots and 2 calibrator lots where available. 2 replicates from 16 runs (total 32 data points) were performed over distinct runs with minimum 2-hour gaps and 8 calibration events. |
| Open Vial Stability | Point of failure determined by analyte-specific maximum allowable drift (degradation). | 10 days at 2 to 8°C for most analytes. Exceptions: - 7 days at 2 to 8°C for Triglycerides; - 5 days at 2 to 8°C for Lactate. |
| Shelf-Life Stability | Drift Limit of 10% for Multichem S Plus (Assayed) controls. | Predicted to be stable for in excess of 30 months when stored at -20℃ to -80℃, based on a combination of accelerated and preliminary real-time testing (real-time testing on-going). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Value Assignment Test Set: 32 data points per analyte (2 replicates from 16 runs).
- Open Vial Stability Test Set: Replicates of 3 for each analyte at each time point.
- Shelf-Life Stability Test Set: 3 lots for accelerated testing, 2 lots for real-time testing.
- Data Provenance: The studies were performed internally by Technopath, a company based in Ireland (Ballina, Co. Tipperary, Ireland). The data is generated from laboratory testing using specific instruments (Abbott ARCHITECT c8000, i2000, Beckman Coulter® AU480). This would be considered prospective data generation for the purpose of validating the control material.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This question is not applicable. For this type of quality control material, the "ground truth" is typically established by precisely measuring the analyte concentrations using highly accurate and precise reference methods within a laboratory setting, rather than through expert consensus on qualitative observations. The document mentions "Value assignment testing was performed utilizing internal procedures and protocols to determine typical values," which implies a metrological approach, not expert adjudication.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods like '2+1' or '3+1' are used for interpreting subjective data (e.g., medical images) to establish a ground truth. For quantitative chemical measurements, the "ground truth" (assigned values) are determined through statistical analysis of multiple precise measurements, not by expert consensus or adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This question is not applicable. An MRMC study is relevant for evaluating the impact of AI on human diagnostic performance, typically with interpreting medical images or other complex diagnostic tasks. This device is a quality control material for laboratory instruments and does not involve AI or human readers in the diagnostic workflow.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. This device is a quality control material, not an algorithm or an AI system. Its performance is evaluated by how accurately and stably it represents known analyte concentrations when measured by laboratory instruments.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the Multichem S Plus / S Plus (Assayed) control is the assigned value (concentration) for each analyte within the control material. This is established through meticulous laboratory measurement and statistical analysis across multiple runs, instruments, reagents, and calibrators, as described in section 8.1 "Value Assignment Summary." It is not based on expert consensus, pathology, or outcomes data, but on the accurate quantification of chemical substances.
8. The sample size for the training set
This question is not applicable in the context of an AI training set, as the device is not an AI algorithm. If "training set" refers to the data used to establish the assigned values for the control, then for "Value Assignment":
- For Multichem S Plus (Assayed) controls, 2 reagent lots and 2 calibrator lots were used where available.
- 2 replicates from 16 runs were performed to give a total of 32 data points per analyte.
- A minimum of 8 calibration events were performed.
For stability studies, multiple lots of control material were used with results generated over various time points.
9. How the ground truth for the training set was established
Again, if "training set" refers to the data used for value assignment of the control material:
The "ground truth" (the assigned value for each analyte) was established through a rigorous value assignment process as described in section 8.1. This involved:
- Utilizing internal procedures and protocols.
- Running the controls on specific clinical chemistry and immunoassay systems (Abbott ARCHITECT c8000, ARCHITECT i2000).
- Incorporating reagent and calibrator variation by using 2 reagent lots and 2 calibrator lots.
- Performing 32 data points (2 replicates from 16 distinct runs).
- Ensuring minimum gaps of 2 hours between runs.
- Incorporating variation from calibration and environmental sources through a minimum of 8 calibration events.
- The "grand mean" of these comprehensive measurements was used to establish the assigned value, around which the value assignment ranges were then set.
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K132751
510(k) Summary Multichem S Plus / S Plus (Assayed) Control
1.0 Submitter:
Submitter Contact:
Paula McCarthy Head of Quality and Regulatory Affairs Technopath Fort Henry Business Park Ballina, Co. Tipperary Ireland Telephone: + 353 61 335844 Fax: + 353 61 203034 Email: paula.mccarthy@techno-path.com
Stephanie G. Garth Consultant Global Compliance Plus 325 Big Elm St. Highland Village, TX 75077 Telephone: 469-230-0959 Email: globalcomplianceplus@yahoo.com
2.0 Date Submitted:
August 28, 2013
OCT 2 2 2013
3.0 Device Identification
| Proprietary Names: | Multichem S Plus / S Plus (Assayed) |
|---|---|
| Common Name: | Multi-Analyte Controls, (Assayed and unassayed) |
| Classification: | Class 1, Reserved |
| Product Code: | JJY |
| Regulation Number: | 21 CFR 862.1660 |
: 4.0 Legally Marketed Predicate Device
| Candidate(s) . | «Predicate : | Manufacturer. | Document- Number |
|---|---|---|---|
| Multichem S Plus / S | Liquid Assayed Multiqual® | Bio-Rad | K043208 |
| Plus (Assayed) | (Model #s 694, 695, 696, 695X) | Laboratories |
The Multichem S Plus (Assayed) control is substantially equivalent to the Bio-Rad product listed above, currently in commercial distribution.
Device Description 5.0
The use of quality control material is indicated as an objective assessment of the precision of methods and techniques and is an integral part of good laboratory practices. Three levels of control are available to allow performance monitoring within the analytical range. There is no difference in the formulation or manufacturing procedure between Multichem S Plus and Multichem S Plus (Assayed). Both are multi-analyte assayed QC materials with the same formula; however, there is a difference only in the product claims that are published to the users.
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The following kit configurations are available:
Multichem S Plus (Assayed)
Model 05P78-10 with Level 1 control; 12 vials with 5 mL contents Model 05P78-11 with Level 2 control; 12 vials with 5 mL contents Model 05P78-12 with Level 3 control; 12 vials with 5 mL contents
Multichem S Plus
Model CH101PLA with Level 1 control; 15 vials with 10 mL contents Model CH102PLA with Level 2 control; 15 vials with 10 mL contents Model CH103PLA with Level 3 control; 15 vials with 10 mL contents
Each donor unit used in the preparation of the control material was tested by United States Food and Drug Administration (FDA) approved methods and found to be negative for antibodies to HIV and HCV, and non-reactive for HBsAg.
6.0 Intended Use
Multichem S Plus / S Plus (Assayed) control are intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
Note: The following analytes are listed below in the table in section 7.0, in the package insert, and in the Indications for Use Form.
7.0 Comparison to the Predicate
Multichem S Plus / S Plus (Assayed) Plus control claims to be substantially equivalent to Liquid Assayed Multiqual . The controls have same/similar design and modes of operation. The key features are summarized in the following table.
| Characteristics | Predicate Device:Liquid AssayedMultiqual® | Proposed Device:Multichem S Plus / S Plus (Assayed) Controls |
|---|---|---|
| Similarities | ||
| Intended Use: | Liquid AssayedMultiqual is intended foruse as an assayed qualitycontrol serum to monitorthe precision oflaboratory testingprocedures for theanalytes listed in thepackage insert. | Multichem S Plus / S Plus (Assayed) control areintended for use as an assayed quality control serumto monitor the precision of laboratory testingprocedures for the analytes listed in the packageinsert. |
| Form: | Liquid, Frozen | Liquid, Frozen |
| Matrix: | Human serum based | Human serum based |
| Storage(Closed/Shelf-Life) | -20°C to -70°C Untilexpiration date | -20°C to -80°C Until expiration date |
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| Analytes | Multiqual® | Multichem S Plus | Multichem S Plus(Assayed) |
|---|---|---|---|
| Acetaminophen | Acetaminophen | Acetaminophen | Acetaminophen |
| Alpha-1 | Alpha-1 | Alpha-1 | |
| Acidglycoprotein | Acidglycoprotein | ||
| Alpha-1-Antitripsin | Alpha-1-AntitripsinαHBDH | Alpha-1 Antitrypsin | Alpha-1 Antitrypsin |
| Apolipoprotein A-1 | Apolipoprotein A-1 | Apolipoprotein A1 | Apolipoprotein A1 |
| Apolipoprotein B | Apolipoprotein B | Apolipoprotein B | Apolipoprotein B |
| Alkaline Phosphatase | Alkaline Phosphatase(ALP) | Alkaline Phosphatase | Alkaline Phosphatase |
| ALT/SGPT | ALT/SGPT | Alanine | Alanine |
| Aminotransferase | Aminotransferase | ||
| Amikacin | Amikacin | Amikacin | Amikacin |
| Amylase | Amylase | Amylase | Amylase |
| Amylase, Pancreatic | Amylase, PancreaticAST/SGOT | Amylase, Pancreatic | |
| Aspartate | Aspartate | ||
| Aminotransferase | Aminotransferase | ||
| Acid Phosphatase | Acid Phosphatase | Acid Phosphatase | |
| Albumin | Albumin | Albumin | Albumin |
| Beta-2 Microglobulin | Beta-2 Microglobulin | ||
| Bile acids | |||
| Bilirubin, Direct | Bilirubin, Direct | Bilirubin, Direct | Bilirubin, Direct |
| Bilirubin, Neonatal | Bilirubin, Neonatal | ||
| Bilirubin, Total | Bilirubin, Total | Bilirubin, Total | Bilirubin, Total |
| C3 Complement | C3 Complement | Complement C3 | Complement C3 |
| C4 Complement | C4 Complement | Complement C4 | Complement C4 |
| Ceruloplasmin | Ceruloplasmin | Ceruloplasmin | Ceruloplasmin |
| Cholinesterase | Cholinesterase | Cholinesterase | |
| Calcium, Ionized | Calcium, Ionized | ||
| Copper | Copper | ||
| Calcium, Total | Calcium, Total | Calcium | Calcium |
| Carbamazepine | Carbamazepine | Carbamazepine | Carbamazepine |
| Carbon Dioxide (CO2) | Carbon Dioxide (CO2) | Carbon Dioxide(Bicarbonate) | Carbon Dioxide(Bicarbonate) |
| Chloride | Chloride | Chloride | Chloride |
| HDL | HDL | Cholesterol, HDL | Cholesterol, HDL |
| LDL | LDL | Cholesterol, LDL | Cholesterol, LDL |
| Cholesterol, Total | Cholesterol, Total | Cholesterol, Total | Cholesterol, Total |
| CK-MB Isoenzyme | CK-MB Isoenzyme | ||
| Cortisol | Cortisol | Cortisol | |
| Creatinine | Creatinine | Creatinine | Creatinine |
| Creatine Kinase (CK) | Creatine Kinase (CK) | Creatine Kinase | Creatine Kinase |
| C-Reactive Protein | C-Reactive Protein | ||
| Digoxin | Digoxin | ||
| Digoxin | Digoxin | ||
| Ferritin | Ferritin | ||
| Ethanol | Ethanol | Ethanol | Ethanol |
| GGT | GammaGlutamyltransferase | GammaGlutamyltransferase | |
| Gentamicin | Gentamicin | Gentamicin | |
| Globulin | Glucose | Glucose | |
| Glucose | Haptoglobin | Haptoglobin | |
| Haptoglobin | Iron | Iron | |
| Iron | Immunoglobulin A | Immunoglobulin A | |
| Immunoglobulin A (IgA) | Immunoglobulin G | Immunoglobulin G | |
| Immunoglobulin G (IgG) | Immunoglobulin M | Immunoglobulin M | |
| Immunoglobulin M (IgM) | TIBC | ||
| UIBC | Unsaturated Iron Binding Capacity (UIBC) | Unsaturated Iron Binding Capacity (UIBC) | |
| Lactate (Lactic Acid) | Lactate (Lactic acid) | Lactate (Lactic acid) | |
| LDH | Lactate Dehydrogenase | Lactate Dehydrogenase | |
| LAP Arylamidase | Lipase | Lipase | |
| Lipase | Lithium | Lithium | |
| Lithium | Magnesium | Magnesium | |
| Magnesium | Osmolality | ||
| Osmolality | Phenobarbital | Phenobarbital | |
| Phenobarbital | Phenytoin | ||
| Phenytoin | Phospholipids | ||
| Phospholipids | Phosphorus | Phosphorous | |
| Phosphorus | Potassium | Potassium | |
| Potassium | Prealbumin | Prealbumin | |
| Prealbumin | PAP | ||
| PAP | Protein Electrophoresis | ||
| Protein Electrophoresis | Protein, Total | Protein, Total | |
| Protein, Total | Rheumatoid Factor | Rheumatoid Factor | |
| Salicylate | Salicylate | Salicylate | |
| Sodium | Sodium | Sodium | |
| T3 Free | |||
| T3 Total | |||
| T3 Uptake/T-Uptake | |||
| T4 total | Thyroxine (TT4) | ||
| T4 Free | |||
| Theophylline | Theophylline | Theophylline | |
| TSH | |||
| Tobramycin | Tobramycin | Tobramycin | |
| Transferrin | Transferrin | Transferrin | |
| Triglycerides | Triglycerides | Triglycerides | |
| Urea | |||
| Urea Nitrogen (BUN) | Urea Nitrogen | Urea Nitrogen | |
| Uric Acid | Uric Acid | Uric Acid |
:
. . . . .
5-3
{3}------------------------------------------------
:
5-4
.
{4}------------------------------------------------
| Vitamin B12Zinc | Vancomycin | Vancomycin | |
|---|---|---|---|
| Open Vial | 14 days at 2 to 8°C, withthe following exception:Direct Bilirubin,Triglycerides, HDL,Cholinesterase andPhosphorus for 7 days.LAP Arylamidase willbe stable for 3 days. | 10 days at 2 to 8°C with the following exceptions:Triglycerides will be stable for 7 days. Lactate will bestable for 5 days. |
- 8.0 Performance Characteristics
8.1 Value Assignment Summary
Value assignment testing was performed utilizing internal procedures and protocols to determine typical values that would be seen for the controls across Abbott ARCHITECT c8000 clinical chemistry and the ARCHITECT i2000 immunoassay systems with the associated reagent test systems. For the Multichem S Plus (Assayed) controls, 2 reagent fots and 2 calibrator lots were used where available to incorporate reagent and calibrator variation. 2 replicates from 16 runs were performed to give a total of 32 data points. Distinct runs, with minimum gaps of 2 hours were performed and a minimum of 8 calibration events were performed to incorporate variation from calibration and environmental sources. Value assignment ranges were established at the pre-determined criteria of 20% around the grand mean and expanded to 30% or as needed. However, a 10% range is applied to Potassium, Sodium and Chloride.
8.2 Stability Testing Summary
Stability studies have been performed to determine the open vial stability and shelf-life for this control. For open vial stability, Technopath utilized internal procedures and two protocol methods (Classical [Forward] method and Isochronous - Staggered Start [Back-ended] method) from CLSI EP25A entitled "Evaluation of Stability of In Vitro Diagnostic Reagents." To minimize variation, where possible, one lot of reagent, calibrator and reference/control was used for the entire study, per analyte. Testing was performed over multiple days on 1 Abbott ARCHITECT c8000 clinical chemistry system with the associated reagent test systems, with the exception of Rheumatoid Factor, which was tested on a Beckman Coulter® AU480 chemistry instrument. All Multichem S Plus (Assayed) analytes from open vial and freshly thawed vial samples were tested in replicates of 3 at each time points were tested and the point of failure was determined by the maximum allowable drift (degradation), which was determined to be analyte specific.
{5}------------------------------------------------
Open Vial Stability:
10 days at 2 to 8°C for each analyte with the following exceptions: �
- -7 days at 2 to 8°C for Triglycerides
- 5 days at 2 to 8℃ for Lactate -
A combination of accelerated and preliminary real-time testing was carried out utilizing CLSI EP25A in order to support a shelf-life storage claim of -20° to -80°C for 30 months. The accelerated testing utilized three lots of controls and the real-time testing utilized a combination of two lots of controls. All data was generated using the Abbott ARCHITECT c8000 clinical chemistry system with the associated reagent test systems. For the Multichem S Plus (Assayed) controls, the Drift Limit was determined to be 10%. These results concluded that the Multichem S Plus / S Plus (Assayed) controls are predicted to be stable for in excess of 30 months when stored at -20℃ to - 80℃. The real-time testing is on-going.
Note: ARCHITECT, c8000, and i2000 are trademarks of Abbott Laboratories.
8.3 Traceability Summary
The analytes contained within the Multichem S Plus (Assaved) controls were obtained from endogenous components to the base serum matrix and commercially available sources. Technopath does not claim traceability to higher order reference materials or methods.
9.0 Conclusion:
The conclusions drawn from the nonclinical tests (discussed above) demonstrate that the Multichem S Plus / S Plus (Assayed) control is as safe, as effective, and performs as well as the predicate device. The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
{6}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three wavy lines emanating from a central point. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 22, 2013
TECHNO-PATH MANUFACTURING LTD. c/o Stephanie G. Garth Global Compliance Plus 325 Big Elm Street HIGHLAND VILLAGE TX 75077
Re: K132751 Trade/Device Name: Multichem S Plus / S Plus (assayed) Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: I, reserved Product Code: JJY Dated: August 28, 2013 Received: September 3, 2013
Dear Ms. Garth:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{7}------------------------------------------------
Page 2-Ms. Garth
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Carol Benson -S for
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
{8}------------------------------------------------
Indications for Use Form
K132751 510(k) Number (if known):
Device Name: Multichem S Plus / S Plus (Assayed)
Indications for Use:
Mukichem S Plus / S Plus (Assayed) control are intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures fisted in the package insert. Note: The following analytes are listed in the package insert:
Multichem S Plus
Acetaminophen Alpha-1 Acidglycoprotein Alpha-1 Antitrypsin Apolipoprotein A 1 Apolipoprotein B Alkaline Phosphatase Alanine Aminotransferase Amikacin Amylase Amylase, Pancreatic Aspartate Aminotransferase Acid Phosphatase Albumin Beta-2 Microglobulin Bile acids Bilirubin, Direct Bilirubin, Total Complement C3 Complement C4 Ceruloplasmin Cholinesterase Calcium
Multichem S Plus (Assayed)
Acetaminophen Alpha-1 Acidgly coprotein Alpha-1 Antitrypsin Apolipoprotein Al Apolipoprotein B Alkaline Alanine Aminotransferase Amikacin Amylase Aspartate Aminotransferase Albumin Beta-2 Microglobulin Bilirubin, Direct Bilirubin, Total Complement C3 Complement C4 Ceruloplasmin Calcium Carbamazenine Carbon Dioxide (Bicarbonate) Chloride
Prescription Use X Over-The-Counter Use AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Yung | [ 20 ] Chan - S
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
K132751 510(k)
Page 1 of 2
{9}------------------------------------------------
Multichem S Plus, cont'd
Carbamazepine Carbon Dioxide (Bicarbonate) Chloride Cholesterol, HDL Cholesterol, LDL Cholesterol, Total Cortisol Creatinine Creatine Kinase C-Reactive Protein Digoxin Ethanol Gamma Glutamyltransferase Gentamicin Glucose Haptoglobin Iron Immunoglobulin A Immunoglobulin G Immunoglobulin M Unsaturated Iron Binding Capacity (UIBC) Lactate (Lactic acid) Lactate Dehydrogenase Lipase Lithium Magnesium Phenobarbital Phenytoin Phosphorous Potassium Prealbumin Protein, Total Rheumatoid Factor Salicylate Sodium Thyroxine (TT4) Theophylline Tobramycin Transferrin Triglycerides Urea Nitrogen Uric Acid Valproic Acid
Multichem S Plus (Assayed), cont'd
Cholesterol. HDL Cholesterol, LDL Cholesterol. Total Creatinine Creatine Kinase C-Reactive Protein Digoxin Ethano) Gamma Glutamyltransferase Gentamicin Glucose Haptoglobin lron Immunoglobulin A Immunoglobulin G Immunoglobulin M Unsaturated Iron Binding Capacity (UIBC) Lactate (Lactic acid) Lactate Dehydrogenase Lipase Lithium Magnesium Phenobarbital Phosphorous Potassium Prealbumin Protein, Total Rheumatoid Factor Salicylate Sodium Theophylline Tobramycin Transferrin Triglycerides Urea Nitrogen Uric Acid Valproic Acid Vancomycin
Prescription Use X Over-The-Counter Use AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Yung YDC
Division Sian-Off Office of In Vitro Diagnostics and Radiological Health
510(k) K132751
Vancomycin
. .
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.