(147 days)
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Not Found
No
The summary describes standard in vitro diagnostic assays for measuring specific analytes in biological samples. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices. The performance studies focus on traditional analytical metrics like imprecision and correlation.
No
The device is an in vitro diagnostic device used to measure various substances in human samples, aiding in diagnosis, monitoring, and treatment decisions, but it does not directly provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the various assays on the Bayer Advia IMS are "in vitro diagnostic device[s] intended to measure..." various substances, and explains how these measurements are "used in the diagnosis, monitoring and treatment of" specific conditions.
No
The device is described as an "in vitro diagnostic device" intended to measure various analytes in human serum, plasma, or blood. This implies the use of physical reagents and laboratory equipment to perform the measurements, which are hardware components, not solely software. The performance studies also describe analytical measurements and correlations with other laboratory instruments.
Yes, the document explicitly states that the Bayer Advia IMS assays are "in vitro diagnostic devices" in the "Intended Use / Indications for Use" section for each listed assay.
N/A
Intended Use / Indications for Use
- Direct Bilirubin (DBIL): "The Bayer Advia IMS Direct Bilirubin assay is an in virro diagnostic device intended to measure conjugated bilirubin in human serum or plasma. Measurements of direct or total bilirubin organic compounds formed during the normal and abnormal destruction of red blood cells, are used in the diagnosis, monitoring and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder disorders."
- Hemoglobin A1c (HbA1c): "The Bayer Advia IMS Hemoglobin A1c (HbA1c) method is an in vitro diagnostic device intended to measure Hemoglobin A1c, a diabetes marker, in human blood. Measurements of HbAlc can bc used for monitoring the long term care of persons with diabetes. The HbAlc and total hemoglobin (THb) values generated as part of the HbA1c assay are intended for use in the calculation of the HbA 1c/THb ratio, and must not be used individually for diagnostic purposes."
- Gentamicin: "The Bayer Advia IMS Gentamicin assay is an in vitro diagnostic device intended to measure gentamicin, an antibiotic drug, in human serum. Measurements of gentamicin are used as an aid in the diagnosis and treatment of gentamicin overdose and in monitoring therapeutic levels of gentamicin to ensure appropriate therapy."
- Magnesium (MG): "The Bayer Advia IMS Magnesium method is an in vitro diagnostic device intended to measure magnesium in human serum, plasma or urine. Measurements of magnesium are used in the diagnosis and treatment of hypomagnesemia, hypermagnesemia and monitoring of patients receiving prolonged magnesium-free intravenous therapv."
- Theophylline (THEO): "The Bayer Advia IMS Theophylline assay is an in vitro diagnostic device intended to measure theophylline in human serum. Measurements of theophyllinc arc used as an aid in the diagnosis and treatment theophylline overdose and in monitoring therapeutic levels of theophylline to ensure appropriate therapy."
- Tobramycin (TOBRA): "The Bayer Advia IMS Tobramvoin assay is in an in vitro diagnostic device intended to quantitatively measure tobramycin, an antibiotic drug, human serum. Measurements of tobramycin are used in the diagnosis and treatment of tobramycin overdose and in monitoring therapeutic levels of tobramycin to ensure appropriate therapy."
- Uric Acid (UA): "The Bayer Advia IMS Uric Acid (UA) method is an in vitro diagnostic device intended to measure uric acid in human serum, plasma, and urine. Such measurements are used as an aid in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, and of patients receiving cytotoxic drugs."
Product codes (comma separated list FDA assigned to the subject device)
CIG, JGJ, KLS, KNK, LCD, LCP, LDO
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Children and adults (Theophylline)
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- D. Bilirubin method for ADVIA 400:
- Imprecision (SERUM):
- ADVIA 400: Level (mg/dL) 0.7, Total CV(%) 9.0; Level (mg/dL) 5.5, Total CV(%) 3.4; Level (mg/dL) 11.8, Total CV(%) 3.3.
- CHEM 1: Level (mg/dL) 0.2, Total CV(%) n/a; Level (mg/dL) 5.0, Total CV(%) 3.9; Level (mg/dL) 8.3, Total CV(%) 3.2.
- Correlation (Y=ADVIA 400, X=comparison system):
- Specimen type: Serum, Comparison System (X): CHEM 1, N: 59, Regression Equation: Y=0.98X-0.10, Syx (mg/dL): 0.19, r: 0.994, Sample Range (mg/dL): 0.0 - 10.6.
- Specimen type: Plasma(y), Serum(x), Comparison System (X): ADVIA 400, N: 59, Regression Equation: Y=0.89X+0.06, Syx (mg/dL): 0.03, r: 0.852, Sample Range (mg/dL): 0.09 - 0.42.
- Interfering Substances:
- Hemoglobin: Conc. 500 mg/dL, D. Bilirubin Conc. 0.9 mg/dL, Effect -17%.
- Lipids (Triglycerides): Conc. 500 mg/dL, D. Bilirubin Conc. 1.8 mg/dL, Effect -69%.
- Analytical Range: Serum/Plasma: 0 to 14 mg/dL.
- Imprecision (SERUM):
- HbA1c Method for ADVIA IMS:
- Minimum Detectable Concentration: ADVIA IMS: 0.61%, RA-1000: 17.2%.
- Imprecision:
- ADVIA IMS: Level % 5.71, Total CV (%) 5.4; Level % 8.36, Total CV (%) 4.7; Level % 11.17, Total CV (%) 4.6.
- Bayer RA-1000: Level (%) 4.6, Total CV (%) 3.4; Level (%) 8.4, Total CV (%) 2.6; Level (%) 11.2, Total CV (%) 2.5.
- Correlation: Specimen type: Serum, Comparison System (X): RA-1000, N: 57, Regression Equation: Y=1.00X + 0.62, Syx %: 0.33, R: 0.991, Sample Range (%): 5.09 - 17.21.
- Interfering Substances:
- Bilirubin (unconjugated): Conc. 25 mg/dL, HbA1c Conc. 5.21 %, Effect -1%.
- Bilirubin (conjugated): Conc. 20 mg/dL, HbA1c Conc. 5.19 %, Effect -2%.
- Urea: Conc. 500 mg/dL, HbA1c Conc. 7.86 %, Effect +4%.
- Lipids (Triglycerides): Conc. 1000 mg/dL, HbA1c Conc. 5.26 %, Effect -4%.
- Analytical Range: 0.61 to 17.2%.
- Gentamicin Method for ADVIA® IMS:
- Minimum Detectable Concentration: ADVIA IMS: 0.06 ug/mL, Immuno 1: 0.11ug/mL.
- Imprecision:
- ADVIA IMS: Level ug/mL 1.79, Total CV (%) 7.2; Level ug/mL, Total CV (%) 4.6; Level ug/mL 9.14, Total CV (%) 4.9.
- Bayer Immuno I: Level ug/mL 3.20, Total CV (%) 4.6; Level ug/mL 7.00, Total CV (%) 2.6; Level ug/mL 9.50, Total CV (%) 2.9.
- Correlation: Specimen type: Serum, Comparison System (X): Immuno 1, N: 54, Regression Equation: Y=1.09X - 0.29, Syx ug/mL: 0.51, R: 0.989, Sample Range ug/mL: 0.5 - 11.5.
- Interfering Substances:
- Bilirubin (unconjugated): Conc. 25 mg/dL, Gentamicin Conc. 4.23 ug/mL, Effect +3%.
- Bilirubin (conjugated): Conc. 20 mg/dL, Gentamicin Conc. 4.34 ug/mL, Effect +3%.
- Hemoglobin: Conc. 600 mg/dL, Gentamicin Conc. 4.37 ug/mL, Effect -4%.
- Lipids (Triglycerides): Conc. 1000 mg/dL, Gentamicin Conc. 4.05 ug/mL, Effect +4%.
- Analytical Range: 0.06 to 16.0 ug/mL.
- Magnesium method for ADVIA® IMS:
- Imprecision (Serum):
- ADVIA IMS: Level (mg/dL) 1.76, Total CV(%) 2.4%; Level (mg/dL) 2.32, Total CV(%) 1.7%; Level (mg/dL) 5.29, Total CV(%) 1.8%.
- CHEM 1: Level (mg/dL) 1.6, Total CV(%) 4.1%; Level (mg/dL) 2.8, Total CV(%) 2.5%; Level (mg/dL) 3.6, Total CV(%) 2.3%.
- Imprecision (Urine):
- ADVIA IMS: Level (mg/dL) 1.00, Total CV(%) 8.6%; Level (mg/dL) 6.50, Total CV(%) 3.7%; Level (mg/dL) 14.24, Total CV(%) 2.1%.
- CHEM 1: Level (mg/dL) 1.1, Total CV(%) 12.6%; Level (mg/dL) 6.5, Total CV(%) 2.9%; Level (mg/dL) 14.2, Total CV(%) 1.4%.
- Correlation (Y=ADVIA IMS, X=comparison system):
- Specimen type: Serum, Comparison System (X): CHEM I, N: 44, Regression Equation: Y=0.97X+0.06, Syx (mg/dL): 0.16, R: 0.998, Sample Range (mg/dL): 0.2 - 8.05.
- Specimen type: Urine, Comparison System (X): CHEM I, N: 48, Regression Equation: 1.02X-0.24, Syx (mg/dL): 0.34, R: 0.998, Sample Range (mg/dL): 1.4 - 25.0.
- Plasma (Y) vs. Serum (X) Comparison: Concentration Plasma 1.97 mg/dL, Serum 1.97 mg/dL, Difference 0%, Sample Range 1.63 - 2.3 mg/dL. Within-run CV Plasma 8.92, Serum 9.73.
- Interfering Substances:
- Serum: Bilirubin (unconjugated): Conc. 25 mg/dL, Magnesium Conc. 2.23 mg/dL, Effect -1%. Bilirubin (conjugated): Conc. 25 mg/dL, Magnesium Conc. 1.98 mg/dL, Effect 0%. Hemoglobin: Conc. 1000 mg/dL, Magnesium Conc. 2.21 mg/dL, Effect +8%. Lipids (Triglycerides): Conc. 500 mg/dL, Magnesium Conc. 2.12 mg/dL, Effect -1%. Calcium: Conc. 20 mg/dL, Magnesium Conc. 2.08 mg/dL, Effect -3%.
- Urine: Ascorbate: Conc. 200 mg/dL, Magnesium Conc. 5.92 mg/dL, Effect +2%. Salicylate: Conc. 500 mg/dL, Magnesium Conc. 5.67 mg/dL, Effect +2%. Acetaminophen: Conc. 50 mg/dL, Magnesium Conc. 6.02 mg/dL, Effect -7%.
- Analytical Range: Serum/Plasma: 0 to 8.0 mg/dL, Urine: 0 to 25 mg/dL.
- Imprecision (Serum):
- Theophylline Method for ADVIA® IMS:
- Minimum Detectable Concentration: ADVIA IMS: 0.47 ug/mL, Immuno: 0.4 Oug/mL.
- Imprecision:
- ADVIA IMS: Level ug/mL 9.37, Total CV (%) 3.4; Level ug/mL 19.59, Total CV (%) 3.0; Level ug/mL 29.17, Total CV (%) 4.1.
- Correlation: Specimen type: Serum, Comparison System (X): RA-1000, N: 51, Regression Equation: Y=0.98X - 0.13, Syx ug/mL: 1.37, R: 0.991, Sample Range ug/mL: 4.1 - 39.6.
- Interfering Substances:
- Bilirubin (unconjugated): Conc. 25 mg/dL, Theophylline Conc. 8.65 ug/mL, Effect +6%.
- Bilirubin (conjugated): Conc. 15 mg/dL, Theophylline Conc. 9.00 ug/mL, Effect +7%.
- Hemoglobin: Conc. 600 mg/dL, Theophylline Conc. 9.03 ug/mL, Effect -4%.
- Lipids (Triglycerides): Conc. 1000 mg/dL, Theophylline Conc. 9.01 ug/mL, Effect -6%.
- Analytical Range: 0.47 to 40 ug/mL.
- Tobramycin Method for ADVIA® IMS:
- Minimum Detectable Concentration: ADVIA IMS: 0.34 ug/mL, Immuno 1: 0.08 ug/mL.
- Imprecision:
- ADVIA IMS: Level g/mL 1.92, Total CV (%) 4.3; Level g/mL 3.71, Total CV (%) 2.9; Level g/mL 7.86, Total CV (%) 3.3.
- Bayer Immuno: Level ug/mL 1.15, Total CV(%) 4.0; Level ug/mL 4.42, Total CV(%) 2.4; Level ug/mL 8.29, Total CV(%) 2.2.
- Correlation: Specimen type: Serum, Comparison System (X): Immuno 1, N: 69, Regression Equation: Y = 0.99X - 0.05, Syx ug/mL: 0.22, R: 0.997, Sample Range ug/mL: 0.3-11.5.
- Interfering Substances:
- Bilirubin (unconjugated): Conc. 25 mg/dL, Tobramycin Conc. 2.36 ug/mL, Effect +6%.
- Bilirubin (conjugated): Conc. 20 mg/dL, Tobramycin Conc. 2.46 ug/mL, Effect +3%.
- Hemoglobin: Conc. 600 mg/dL, Tobramycin Conc. 2.44 ug/mL, Effect 0%.
- Lipids (Triglycerides): Conc. 1000 mg/dL, Tobramycin Conc. 2.42 ug/mL, Effect -1%.
- Analytical Range: 0.34 to 16.0 ug/mL.
- Uric Acid method for ADVIA® IMS:
- Imprecision (SERUM):
- ADVIA IMS: Level (mg/dL) 3.68, Total CV(%) 3.6; Level (mg/dL) 6.84, Total CV(%) 3.2; Level (mg/dL) 11.50, Total CV(%) 1.7.
- CHEM 1: Level (mg/dL) 3.8, Total CV(%) 6.3; Level (mg/dL) 9.3, Total CV(%) 3.1; Level (mg/dL) 16.3, Total CV(%) 3.3.
- Imprecision (URINE):
- ADVIA IMS: Level (mg/dL) 20.5, Total CV(%) 7.2; Level (mg/dL) 32.4, Total CV(%) 4.0; Level (mg/dL) 45.2, Total CV(%) 5.6.
- CHEM 1: Level (mg/dL) N/A, Total CV(%) N/A; Level (mg/dL) 26.4, Total CV(%) 8.2; Level (mg/dL) 35.4, Total CV(%) 7.2.
- Correlation:
- Specimen type: Serum, Comparison System (X): CHEM 1, N: 60, Regression Equation: Y = 0.96X + 0.14, Syx (mg/dL): 0.98, r: 0.973, Sample Range (mg/dL): 1.5 - 19.7 mg/dL.
- Specimen type: Plasma(v), Serum(x), Comparison System (X): ADVIA IMS, N: 60, Regression Equation: Y = 1.01X + 0.06, Syx (mg/dL): 0.16, r: 0.989, Sample Range (mg/dL): 2.9-8.0 mg/dL.
- Specimen type: Urine, Comparison System (X): CHEM 1, N: 51, Regression Equation: Y = 1.11X - 3.1, Syx (mg/dL): 4.0, r: 0.992, Sample Range (mg/dL): 1.0 - 123.0 mg/dL.
- Interfering Substances (In Serum):
- Bilirubin: Conc. 20 mg/dL, Uric Acid Conc. 3.8 mg/dL, Effect -7.9%.
- Hemoglobin: Conc. 500 mg/dL, Uric Acid Conc. 3.8 mg/dL, Effect +15.8%.
- Lipids (Triglycerides): Conc. 500 mg/dL, Uric Acid Conc. 3.8 mg/dL, Effect +36.7%.
- Interfering Substances (In Urine):
- Acetaminophen: Conc. 500 mg/dL, Uric Acid Conc. 18.4 mg/dL, Effect +1.1%.
- Ascorbic Acid: Conc. 200 mg/dL, Uric Acid Conc. 18.4 mg/dL, Effect +10.9%.
- Salicylate: Conc. 500 mg/dL, Uric Acid Conc. 18.4 mg/dL, Effect -2.7%.
- Analytical Range: Serum/Plasma: 0 to 23 mg/dL, Urine: 0 to 200 mg/dL.
- Imprecision (SERUM):
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
- D. Bilirubin method for ADVIA® 400: Technicon CHEM 100 D. Bilirubin
- HbA1c Method for ADVIA IMS: Bayer RA-1000 HbAlc
- Gentamicin Method for ADVIA® IMS: Bayer Immuno 1 Gentamicin
- Magnesium method for ADVIA® IMS: Technicon CHEM 1
- Theophylline Method for ADVIA® IMS: Bayer RA-1000 Theophylline
- Tobramycin Method for ADVIA® IMS: Bayer Immuno I Tobramycin
- Uric Acid method for ADVIA® IMS: Technicon CHEM 1° Uric Acid
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.
Not Found
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).
Not Found
§ 862.1110 Bilirubin (total or direct) test system.
(a)
Identification. A bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.(b)
Classification. Class II.
0
APR 1 0 2000
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS D. Bilirubin method for ADVIA® 400
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92
The assigned 510(k) number is: K993867
1. Intended Use
This in virro diagnostic method is intended to measure D. Bilirubin (a product formed during the normal and abnormal destruction of red blood cells) in human serum or plasma on the Bayer ADVIA 400 system
2. Predicate Device
| Product Name | The first for the first and the count of the count of the commend to be and the comments of the comments of the comments of the comments of the comments of the comments of th | and and and and of the strength and the country of the submitteen and the submitteen
Reagent Part # Calibrator Part # | |
|-----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|--|
| Technicon CHEM 100 D. Bilirubin T01-1522-53 T03-1291-62 | | Canadination of programments and consisted in below and | |
3. Device / Method
| Product Name | | Reagent Part # Calibrator Part #
The for the contract of the commended to the comments of the contract and the many of the many of |
|------------------------|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| ADVIA 400 D. Bilirubin | B41-3723-46 T03-1291-62 | |
A. Imprecision(SERUM)
ADVIA 400 | CHEM 1 | ||
---|---|---|---|
Level | |||
(mg/dL) | Total | ||
CV(%) | Level | ||
(mg/dL) | Total | ||
CV(%) | |||
0.7 | 9.0 | 0.2 | n/a |
5.5 | 3.4 | 5.0 | 3.9 |
11.8 | 3.3 | 8.3 | 3.2 |
Correlation (Y=ADVIA 400, X=comparison system)
Specimen type | Comparison System (X) | N | Regression Equation | Syx (mg/dL) | r | Sample Range (mg/dL) |
---|---|---|---|---|---|---|
Serum | CHEM 1 | 59 | Y=0.98X-0.10 | 0.19 | 0.994 | 0.0 - 10.6 |
Plasma(y), Serum(x) | ADVIA 400 | 59 | Y=0.89X+0.06 | 0.03 | 0.852 | 0.09 - 0.42 |
Interfering Substances
| Interfering
Substance | Interfering Sub.
Conc. (mg/dL) | D. Bilirubin
Conc. (mg/dL) | Effect
(% change) |
|--------------------------|-----------------------------------|-------------------------------|----------------------|
| Hemoglobin | 500 | 0.9 | -17 |
| Lipids (Triglycerides) | 500 | 1.8 | -69 |
Analytical Range
Serum/Plasma: 0 to 14 mg/dL
Gabriel J. Musara Jr.
10/4/22
11/4/92
1
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS HbA1c Method for ADVIA IMS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92.
The assigned 510(k) number is: ___________________(leave blank)
1. Intended Use
This in vitro method is intended to quantitatively measure %HbA1c in human blood on the Bayer ADVIA IMS systems. Measurements of %HbAlc are used to aid in the diagnosis and for monitoring the long term care of persons with diabetes.
2. Predicate Device
| admin
Product Name | Reagent Part # Calibrator Part # | |
---|---|---|
And and the first and the program and the comments of the comments of the first of | ||
Bayer RA-1000 HbAlc | ||
Market Comments of Children Market Market Comments of Comments of Comments of Children Comments of Children Comments of Children Comments of Children Comments of Children Com | T01-3639-01 | Property of the Property of Children Comments of Concerner Comments of Children Comments of Children |
T03-3644-01 |
3. Device / Method
| produktion for the final may and many comprehensive and many management in a many may maging home management of the may and the film of the film of the may and the film of th
Product Name
A Property of Concession Complete of Children Complete of Children Compress of Children Comments of Children Comments of Children Comments of Children Comments of Children Co | Reagent BAN | Calibrator BAN
the with a frequently of the required in the may may may may high comment of the comments of the comments of the |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|------------------------------------------------------------------------------------------------------------------------------------|
| ADVIA IMS HbAlc
And Children Children Comment Comment Comments of Concellent Comments of Children Comments of Children | 00395488 | 08248751 |
Minimum Detectable Concentration
| Method | and and the controlled on the consisted on the consistent of the commended to controllaboration of the comments of the commended on the commended on the commended to commende
ADVIA IMS | RA-1000 |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| and and any and of the many of the many of the many of the many of the many of the many of the many of the many of the many of the many of the many of the many of the many of
MDC | for from the first of the first from the many and the many and the may be the
0.61%
her and the figure the state of the mail of the mail of the mail of the mail and seems and the mail and the mail be mail be mail be mail be mail be mail be mail be mail be ma | - Show and the result of the submit is and the mail be the local be the like the block
17.2% |
A. Imprecision
ADVIA IMS | Bayer RA-1000 | ||
---|---|---|---|
Level | Total | Level | Total |
% | CV (%) | (%) | CV(%) |
5.71 | 5.4 | 4.6 | 3.4 |
8.36 | 4.7 | 8.4 | 2.6 |
11.17 | 4.6 | 11.2 | 2.5 |
| Specimen type | Comparison
System (X) | N | Regression
Equation | Syx
% | R | Sample
Range
(%) |
|---------------|--------------------------|----|------------------------|----------|-------|------------------------|
| Serum | RA-1000 | 57 | $Y=1.00 X + 0.62$ | 0.33 | 0.991 | 5.09 - 17.21 |
Gabriel J. Munoz, Jr.
11/5/99
2
| Interfering
Substance | Interfering Sub.
Conc. (mg/dL) | HbA1c Conc.
(%) | Effect
(% change) |
|-----------------------------|-----------------------------------|--------------------|----------------------|
| Bilirubin
(unconjugated) | 25 | 5.21 | -1 |
| Bilirubin
(conjugated) | 20 | 5.19 | -2 |
| Urea | 500 | 7.86 | +4 |
| Lipids
(Triglycerides) | 1000 | 5.26 | -4 |
D. Analytical Range 0.61 to 17.2%
Date 1/15/99
Bayer Corporation, Business Group Diagnostics Tarrytown, NY.
Gabriel J. Muscaz Jr.
Gabriel J. Muraca, Jr. Manager Regulatory Affairs
3
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Gentamicin Method for ADVIA® IMS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92.
The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________
1. Intended Use
This in vitro method is intended to quantitatively measure gentamicin in human serum on the Bayer ADVIA® IMS systems. Measurements of gentamicin are used to aid in the diagnosis and treatment of gentamicin overdose and in monitoring serum levels of gentamicin to ensure appropriate therapy.
2. Predicate Device
Product Name | Reagent Part # | Calibrator Part # |
---|---|---|
Bayer Immuno 1 | ||
Gentamicin | T01-3154-51 | T03-2864-01 |
3. Device / Method
Product Name | Reagent BAN | Calibrator BAN | ||
---|---|---|---|---|
ADVIA IMS Gentamicin ' | ||||
and the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the first | 02543484 | 05442131 |
Minimum Detectable Concentration
Method | ADVIA IMS | Immuno 1 |
---|---|---|
MDC | 0.06 ug/mL | 0.11ug/mL |
Imprecision
ADVIA IMS | Bayer Immuno I | |||
---|---|---|---|---|
Level | Total | Level | Total | |
ug/mL | CV (%) | ug/mL | CV(%) | |
1.79 | 7.2 | 3.20 | 4.6 | |
ર્સ્વે એ જિલ્લામાં આવેલું એ તાલુકામાં આવેલું એ તાલુકામાં આવેલું એક ગામનાં મુખ્યત્વે ખાતે ખાતે કરવામાં આવેલું એ તાલુકામાં આવેલું એક ગામનાં મુખ્યત્વે આવેલું એક ગામનાં મુખ્યત્વ | 4.6 | 7.00 | 2.6 | |
9.14 | 4.9 | 9.50 | 2.9 |
| Specimen type | Comparison
System (X) | N | Regression
Equation | Syx
µg/mL | R | Sample
Range
µg/mL |
|---------------|--------------------------|----|------------------------|--------------|-------|--------------------------|
| Serum | Immuno 1 | 54 | $Y=1.09X - 0.29$ | 0.51 | 0.989 | 0.5 - 11.5 |
Gabriel J. Muraca Jr.
11/5/99
4
| Interfering
Substance | Interfering Sub.
Conc. (mg/dL) | Gentamicin
Concentration
μg/mL | Effect
(% change) |
|-----------------------------|-----------------------------------|--------------------------------------|----------------------|
| Bilirubin
(unconjugated) | 25 | 4.23 | +3 |
| Bilirubin
(conjugated) | 20 | 4.34 | +3 |
| Hemoglobin | 600 | 4.37 | -4 |
| Lipids
(Triglycerides) | 1000 | 4.05 | +4 |
Analytical Range
0.06 to 16.0 µg/mL
Date 11/5/99
Bayer Corporation, Business Group Diagnostics Tarrytown, NY.
Gabriel J. Muraca, Jr.
Manager Regulatory Affairs
5
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Magnesium method for ADVIA® IMS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92.
The assigned 510(k) number is. _______________________________________________________________________________________________________________________________________________
1. Intended Use
This in vitro method is intended to quantitatively measure magnesium in human serum, plasma and urine on the Bayer ADVIA IMS. Measurements of serum magnesium are used in the diagnosis and treatment of hypomagnesiumia and monitoring of patients receiving prolonged magnesium-free intravenous therapy. Measurements of urine magnesium are used to aid in the management of patients with renal dysfunction.
2. Predicate Device
Product Name | Reagent Part # | Calibrator Part # |
---|---|---|
Technicon CHEM 1 | T01-3269-53 | T03-1291-62 |
3. Device / Method
Product Name | Reagent Part # | Calibrator Part # |
---|---|---|
Bayer ADVIA IMS | BAN 02115121 | T03-1291-62 |
A. Imprecision (Serum)
Level (mg/dL) | Total CV(%) |
---|---|
1.76 | 2.4% |
2.32 | 1.7% |
5.29 | 1.8% |
CHEM 1 | |
---|---|
Level | |
(mg/dL) | Total |
CV(%) | |
1.6 | 4.1% |
2.8 | 2.5% |
3.6 | 2.3% |
B. Imprecision (Urine)
ADVIA IMS | |
---|---|
Level | |
(mg/dL) | Total |
CV(%) | |
1.00 | 8.6% |
6.50 | 3.7% |
14.24 | 2.1% |
CHEM 1 | |
---|---|
Level | |
(mg/dL) | Total |
CV(%) | |
1.1 | 12.6% |
6.5 | 2.9% |
14.2 | 1.4% |
Gabriel J. Murray, Jr.
11/5/99
6
Correlation (Y=ADVIA IMS, X=comparison system)
Specimen type | Comparison System (X) | N | Regression Equation | Syx (mg/dL) | R | Sample Range (mg/dL) |
---|---|---|---|---|---|---|
Serum | CHEM I | 44 | Y=0.97X+0.06 | 0.16 | 0.998 | 0.2 - 8.05 |
Urine | CHEM I | 48 | 1.02X-0.24 | 0.34 | 0.998 | 1.4 - 25.0 |
Plasma (Y) vs. Serum (X) Comparison
Plasma | Serum | N | Difference | Sample Range | |
---|---|---|---|---|---|
mg/dL | mg/dL | 60 | (%) | mg/dL | |
concentration | 1.97 | 1.97 | 0 | 1.63 - 2.3 | |
Within-run CV | 8.92 | 9.73 |
Interfering Substances
| Source | Interfering
Substance | Interfering Sub.
Conc. (mg/dL) | Magnesium Conc
(mg/dL) | Effect
(% change) |
|--------|--------------------------|-----------------------------------|---------------------------|----------------------|
| Serum | Bilirubin (unconjugated) | 25 | 2.23 | -1 |
| Serum | Bilirubin (conjugated) | 25 | 1.98 | 0 |
| Serum | Hemoglobin | 1000 | 2.21 | +8 |
| Serum | Lipids (Triglycerides) | 500 | 2.12 | -1 |
| Serum | Calcium | 20 | 2.08 | -3 |
| Urine | Ascorbate | 200 | 5.92 | +2 |
| Urine | Salicylate | 500 | 5.67 | +2 |
| Urine | Acetaminophen | 50 | 6.02 | -7 |
Analytical Range
Serum/Plasma: 0 to 8.0 mg/dL Urine: 0 to 25 mg/dL
Gabriel J. Munoz, Jr.
11/5/99
Date
Gabriel J. Muraca, Jr. Manager Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097
7
Image /page/7/Picture/0 description: The image contains a series of small, dark, indistinct shapes arranged in a diagonal line from the upper left to the lower right. The shapes appear to be isolated against a bright, uniform background, making them stand out despite their small size. Due to the lack of detail, it is difficult to determine the exact nature or purpose of these shapes.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Theophylline Method for ADVIA® IMS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92.
The assigned 510(k) number is: _______________________________________________(leave blank)
1. Intended Use
This in vitro method is intended to quantitatively measure theophylline in human serum on the Bayer ADVIA® IMS systems. Measurements of theophylline are used to aid in the diagnosis and treatment of theophylline overdose and asthama in children and adults.
2. Predicate Device
| Product Name | | . Phone of the contributed the result of the result of the may of the contributed to the comments of the may of the comments of the may of the comments of the may of the comm
Reagent Part # Calibrator Part # |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Bayer RA-1000 | T01-1695-01 | and the country of the count of the count of the county of the county of the county of the county of the county of the county of the county of the county of the county of the
T03-1692-01 |
| Theophylline
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | |
3. Device / Method
| Product Name
of the completed by the program and the promotive of the comments of the comments of the comments of | Reagent BAN | Calibrator BAN |
---|---|---|
ADVIA IMS Theophylline | 03246211 | |
and the many of the control of the contribution of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comment | 08491893 | |
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
Minimum Detectable Concentration
| www.comments.com/short/colors/colors/controllers/
Method | age of the contract of the program and the province the complex of the may be any the complex of the manufactures of the manufactures of the manufacturer
ADVIA IMS | Immuno |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Householder from the would many from and the confinited the finition of the find of the find of the find of the first of the first of the first for the find of the find of th
MDC
Management of American Collection of Children Comments of Street Charge of States of States of States of States of States of States of States of States of States of States of | of the many of the many of the many of the many of the many of the many of the more of the many of
0.47 ug/mL
Company of the program and the manager of the comments of the comments of the comments of the comments of the count | 1 0.4 Oug/mL |
A. Imprecision
ADVIA IMS | |
---|---|
Level | |
μg/mL | Total |
CV (%) | |
9.37 | 3.4 |
19.59 | 3.0 |
29.17 | 4.1 |
| Specimen type | Comparison System (X) | N | Regression Equation | Syx
µg/mL | R | Sample Range
µg/mL |
|---------------|-----------------------|----|---------------------|--------------|-------|-----------------------|
| Serum | RA-1000 | 51 | $Y=0.98 X - 0.13$ | 1.37 | 0.991 | 4.1 - 39.6 |
Gabriel J. Mware, Jr.
11/5/99
8
| Interfering
Substance | Interfering Sub.
Conc. (mg/dL) | Theophylline
Concentration
μg/mL | Effect
(% change) |
|-----------------------------|-----------------------------------|----------------------------------------|----------------------|
| Bilirubin
(unconjugated) | 25 | 8.65 | +6 |
| Bilirubin
(conjugated) | 15 | 9.00 | +7 |
| Hemoglobin | 600 | 9.03 | -4 |
| Lipids
(Triglycerides) | 1000 | 9.01 | -6 |
Analytical Range 0.47 to 40 µg/mL
Date 11/07/99
Bayer Corporation, Business Group Diagnostics Tarrytown, NY.
Gabriel J. Muraca, Jr.
Gabriel J. Muraca, Jr.
Manager Regulatory Affairs
9
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Tobramycin Method for ADVIA® IMS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92.
The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________ (leave blank)
1. Intended Use
This in vitro method is intended to quantitatively measure tobramycin in human serum on the Bayer ADVIA® IMS systems. Measurements of tobram circums are used to aid in the diagnosis and treatment of tobramycin overdose and in monitoring serum levels of tobramycin to ensure appropriate therapy.
2. Predicate Device
Product Name | Reagent Part # | Calibrator Part # |
---|---|---|
Bayer Immuno I | ||
Tobramycin | T01-3157-51 | T03-2864-01 |
3. Device / Method
Product Name | Reagent BAN | Calibrator BAN |
---|---|---|
ADVIA IMS Tobramycin ' | ||
Property of the proportion of the program and one of the first of the first of the first of the first of | 04946969 | 05442131 |
Minimum Detectable Concentration
Method | ADVIA IMS | Immuno 1 |
---|---|---|
MDC | 0.34 $ $\mu$ $ g/mL | 0.08 $ $\mu$ $ g/mL |
A. Imprecision
I
ਜ
ADVIA IMS | Bayer Immuno | ||
---|---|---|---|
Level | Total | Level | Total |
g/mL | CV (%) | μg/mL | CV(%) |
1.92 | 4.3 | 1.15 | 4.0 |
3.71 | 2.9 | 4.42 | 2.4 |
7.86 | 3.3 | 8.29 | 2.2 |
Specimen type | Comparison System (X) | N | Regression Equation | Syx μg/mL | R | Sample Range μg/mL |
---|---|---|---|---|---|---|
Serum | Immuno 1 | 69 | $Y = 0.99X - 0.05$ | 0.22 | 0.997 | 0.3-11.5 |
Gabriel J. Munoz, Jr.
11/5/99
10
| Interfering
Substance | Interfering Sub.
Conc. (mg/dL) | Tobramycin
Concentration
µg/mL | Effect
(% change) |
|-----------------------------|-----------------------------------|--------------------------------------|----------------------|
| Bilirubin
(unconjugated) | 25 | 2.36 | +6 |
| Bilirubin
(conjugated) | 20 | 2.46 | +3 |
| Hemoglobin | 600 | 2.44 | 0 |
| Lipids
(Triglycerides) | 1000 | 2.42 | -1 |
Analytical Range 0.34 to 16.0 µg/mL
Date 11/5/99
Bayer Corporation, Business Group Diagnostics Tarrytown, NY.
Gabriel J. Murray, Jr.
Gabriel J. Muraca, Jr. Manager Regulatory Affairs
11
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Uric Acid method for ADVIA® IMS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807 92
The assigned 510(k) number is: _
1. Intended Use
This in varo diagnostic method is intended to measure Uric Acid in human serum, plasma or urine on the Bayer ADVIA IMS system
2. Predicate Device
Product Name | Reagent Part # | Calibrator Part # |
---|---|---|
Technicon CHEM 1° Uric Acid | T01-1655-53 | T03-1291-62 |
3. Device / Method
Product Name | Reagent Part # Calibrator Part # | |
---|---|---|
ADVIA IMS Uric Acid | 05132620 | |
was and the commend of the commend of the been and the been | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |
T03-1291-62 |
ﻧﮯ Imprecision(SERUM)
ADVIA IMS | CHEM 1 | ||
---|---|---|---|
Level | |||
(mg/dL) | Total | ||
CV(%) | Level | ||
(mg/dL) | Total | ||
CV(%) | |||
3.68 | 3.6 | 3.8 | 6.3 |
6.84 | 3.2 | 9.3 | 3.1 |
11.50 | 1.7 | 16.3 | 3.3 |
B. Imprecision(URINE)
ADVIA IMS | CHEM 1 | ||
---|---|---|---|
Level | |||
(mg/dL) | Total | ||
CV(%) | Level | ||
(mg/dL) | Total | ||
CV(%) | |||
20.5 | 7.2 | N/A | N/A |
32.4 | 4.0 | 26.4 | 8.2 |
45.2 | 5.6 | 35.4 | 7.2 |
Specimen type | Comparison System (X) | N | Regression Equation | Syx (mg/dL) | r | Sample Range (mg/dL) |
---|---|---|---|---|---|---|
Serum | CHEM 1 | 60 | $Y = 0.96X + 0.14$ | 0.98 | 0.973 | 1.5 - 19.7 mg/dL |
Plasma(v), Serum(x) | ADVIA IMS | 60 | $Y = 1.01X + 0.06$ | 0.16 | 0.989 | 2.9-8.0 mg/dL |
Urine | CHEM 1 | 51 | $Y = 1.11X - 3.1$ | 4.0 | 0.992 | 1.0 - 123.0 mg/dL |
Gabriel J. Munaco, Jr.
11/5/99
12
Interfering Substances(In Serum)
| Interfering
Substance | Interfering Sub.
Conc. (mg/dL) | Uric Acid Conc.
(mg/dL) | Effect
(% change) |
|--------------------------|-----------------------------------|----------------------------|----------------------|
| Bilirubin | 20 | 3.8 | -7.9 |
| Hemoglobin | 500 | 3.8 | +15.8 |
| Lipids (Triglycerides) | 500 | 3.8 | +36.7 |
Interfering Substances(In Urine)
| Interfering
Substance | Interfering Sub.
Conc. (mg/dL) | Uric Acid Conc.
(mg/dL) | Effect
(% change) |
|--------------------------|-----------------------------------|----------------------------|----------------------|
| Acetaminophen | 500 | 18.4 | +1.1 |
| Ascorbic Acid | 200 | 18.4 | +10.9 |
| Salicylate | 500 | 18.4 | -2.7 |
Analytical Range
Serum/Plasına Urine:
0 10 23 ing/dL 0 to 200 mg/dL
Gabriel J. Munoz, Jr.
///5799
13
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/13/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name arranged in a circular pattern around a stylized emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three horizontal lines above it.
Public Health Service
APR 1 0 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Gabriel J. Muraca, Jr. Manager Regulatory Affairs Bayer Corporation Business Group Diagnostic 511 Benedict Avenue Tarrytown, New York 10591-5097
Re: K993867 Trade Name: Bayer ADVIA® IMS System Regulatory Class: II Product Code: CIG, JGJ, KLS, KNK, LCD, LCP, LDO Dated: February 21, 2000 Received: February 29, 2000
Dear Mr. Muraca:
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 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). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (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 action. In addition, FDA may publish further announcements 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 regulations.
14
Page 2
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours.
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
15
Page 1 of 3
K493867 510(k) Number (if known):
Device Name: Direct Bilirubin (DBIL)
Indications For Use:
The Bayer Advia IMS Direct Bilirubin assay is an in virro diagnostic device intended to measure conjugated bilirubin in human serum or plasma. Measurements of direct or total bilirubin organic compounds formed during the normal and abnormal destruction of red blood cells, are used in the diagnosis, monitoring and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder disorders.
Device Name: Hemoglobin A1c (HbA1c)
Indications For Use:
The Bayer Advia IMS Hemoglobin A1c (HbA1c) method is an in vitro diagnostic device intended to measure Hemoglobin A1c, a diabetes marker, in human blood. Measurements of HbAlc can bc used for monitoring the long term care of persons with diabetes. The HbAlc and total hemoglobin (THb) values generated as part of the HbA1c assay are intended for use in the calculation of the HbA 1c/THb ratio, and must not be used individually for diagnostic purposes.
e
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K493867
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109) Optional Formal 1-2-96
16
Page 2 of 3
510(k) Number (if known):
Device Name: Gentamicin
Indications For Use:
The Bayer Advia IMS Gentamicin assay is an in vitro diagnostic device intended to measure gentamicin, an antibiotic drug, in human serum. Measurements of gentamicin are used as an aid in the diagnosis and treatment of gentamicin overdose and in monitoring therapeutic levels of gentamicin to ensure appropriate therapy.
Device Name: Magnesium (MG)
Indications For Usc:
The Bayer Advia IMS Magnesium method is an in vitro diagnostic device intended to measure magnesium in human serum, plasma or urine. Measurements of magnesium are used in the diagnosis and treatment of hypomagnesemia, hypermagnesemia and monitoring of patients receiving prolonged magnesium-free intravenous therapv.
Device Name: Theophylline (THEO)
Indications For Use:
The Bayer Advia IMS Theophylline assay is an in vitro diagnostic device intended to measure theophylline in human serum. Measurements of theophyllinc arc used as an aid in the diagnosis and treatment theophylline overdose and in monitoring therapeutic levels of theophylline to ensure appropriate therapy.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
---|---|---|
Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use ______ |
Sean Cooge | Optional Formal 1-2-96 | |
(Division Sign-Off) | ||
Division of Clinical Laboratory Devices | ||
510(k) Number: K993862 |
17
510(k) Number (if known):
Device Name: Tobramycin (TOBRA)
Indications For Use:
The Bayer Advia IMS Tobramvoin assay is an in vitro diagnostic device intended to quantitatively measure tobramycin, an antibiotic drug, human serum. Measurements of tobramycin are used in the diagnosis and treatment of tobramycin overdose and in monitoring therapeutic levels of tobramycin to ensure appropriate therapy.
Device Name: Uric Acid (UA)
Indications For Use:
The Bayer Advia IMS Uric Acid (UA) method is an in vitro diagnostic device intended to measure uric acid in human serum, plasma, and urine. Such measurements are used as an aid in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, and of patients receiving cytotoxic drugs.
in Cooper
on of Clinical L 510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concuplence of CDRH, Office of Device Evaluation (ODE)
Prescription Use 2 (Per 21 CFR 801.109)
OR
Over-The-Counter Use
Optional Formal 1-2-96