(132 days)
No
The document describes chemical reagents and their use in clinical chemistry systems for quantitative determination of analytes. There is no mention of AI or ML in the intended use, device description, or performance studies. The analysis is based on chemical reactions and absorbance measurements.
No
The device is an in vitro diagnostic reagent used to measure concentrations of substances in serum and plasma for diagnostic purposes, not for treating a condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the various reagents are used for the quantitative determination of substances like carbon dioxide, bilirubin, and magnesium, and that these measurements "are used in the diagnosis and treatment of numerous potentially serious disorders" for various conditions. The phrase "For in vitro diagnostic use only" is also present, which signifies its diagnostic purpose.
No
The device described is a reagent kit intended for use with specific clinical chemistry systems (hardware). It is an in vitro diagnostic product, not a software-only medical device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states that the reagents are "intended for the quantitative determination of carbon dioxide concentration in serum and lithium heparin plasma," "intended for the quantitative determination of direct bilirubin concentration in serum and lithium heparin plasma," "intended for the quantitative determination of total bilirubin concentration in serum and lithium heparin plasma," and "intended for the quantitative determination of magnesium in serum and lithium heparin plasma." It also states that these measurements are "used in the diagnosis and treatment of numerous potentially serious disorders." This clearly indicates that the reagents are used to test samples taken from the human body to provide information for diagnostic purposes.
- "For in vitro diagnostic use only": This phrase is explicitly stated for each reagent, which is a common and definitive indicator of an IVD.
- Device Description: The description details how the reagents interact with the sample (serum and plasma) to produce a measurable result, which is characteristic of an in vitro diagnostic test.
- Intended User / Care Setting: The intended users are "clinical laboratories or physician office laboratories," which are settings where in vitro diagnostic testing is performed.
- Performance Studies: The document describes performance studies including precision and method comparison, which are standard evaluations for IVD devices to demonstrate their accuracy and reliability.
- Predicate Device(s): The mention of predicate devices with K numbers (K931786) indicates that these reagents are being compared to previously cleared IVD devices.
All of these factors strongly support the classification of these reagents as In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The ACE Carbon Dioxide (CO2-LC) Reagent is intended for the quantitative determination of carbon dioxide concentration in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance. This test is intended for use in clinical laboratories and physician office laboratories. For in vitro diagnostic use only.
The ACE Direct Bilirubin Reagent is intended for the quantitative determination of direct bilirubin concentration in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic, hematological and metabolic disorders, including hepatitis and gall bladder block. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
The ACE Total Bilirubin Reagent is intended for the quantitative determination of total bilirubin concentration in serum and lithium heparin plasma using the ACE, ACE Alera and ACE Axcel Clinical Chemistry System. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic, hematological and metabolic disorders, including hepatitis and gall bladder block. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
The ACE Magnesium Reagent is intended for the quantitative determination of magnesium in serum and lithium heparin plasma using the ACE, ACE Alera and ACE Axcel Clinical Chemistry Systems. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium). This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
Product codes
KHS, CIG, JGJ
Device Description
In the ACE Carbon Dioxide (CO2-LC) Reagent assay, serum carbon dioxide (in the form of bicarbonate) reacts with phosphoenolpyruvate in the presence of phosphoenolpyruvate carboxylase and magnesium to yield oxaloacetic acid and phosphate. In the presence of malate dehydrogenase, the reduced cofactor is oxidized by oxaloacetic acid. The reduced cofactor absorbs strongly at 408 nm whereas its oxidized form does not. The rate of decrease in absorbance, monitored bichromatically at 408 nm/692 nm, is proportional to the carbon dioxide content of the sample.
In the ACE Direct Bilirubin Reagent assay, sodium nitrite added to sulfanilic acid forms diazotized sulfanilic acid. Bilirubin glucuronide in serum reacts with diazotized sulfanilic acid to form azobilirubin, which absorbs strongly at 554 nm. The increase in absorbance, measured bichromatically at 554 nm/692 nm, one minute after sample addition, is directly proportional to the direct bilirubin concentration.
In the ACE Total Bilirubin Reagent assay, sodium nitrite, when added to sulfanilic acid, forms diazotized sulfanilic acid. Bilirubin in serum reacts with diazotized sulfanilic acid to form azobilirubin, which absorbs strongly at 554 nm. The inclusion of dimethyl sulfoxide (DMSO) in the reagent as an accelerator causes both direct and indirect bilirubin to react rapidly. The increase in absorbance, measured bichromatically at 554 nm/692 nm, is directly proportional to the total bilirubin concentration in the sample.
Magnesium ions in serum react with Xylidyl blue-1 in an alkaline medium to produce a red complex which is measured bichromatically at 525 nm/692 nm. The intensity of color produced is directly proportional to the magnesium concentration in the sample. EGTA prevents calcium interference by preferential chelation of calcium present in the sample. A surfactant system is included to remove protein interference.
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
Not Found
Intended User / Care Setting
clinical laboratories and physician office laboratories.
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)
Performance Data was collected for the Alfa Wassermann ACE Reagents run on the Alfa Wassermann ACE, ACE Alera and ACE Axcel Clinical Chemistry Systems.
In-House Precision: Serum vs. Plasma - ACE CO2-LC Reagent. Precision (SD, %CV) was evaluated at ACE, Alera, and Axcel systems for serum (low, mid, high levels) and plasma (low, mid, high levels).
For ACE, serum precision ranged from 0.27, 1.1% (within-run) to 1.34, 5.6% (total) for low serum. Plasma precision ranged from 0.29, 1.3% (within-run) to 0.86, 3.8% (total) for low plasma.
Similar detailed precision results are provided for Alera and Axcel systems.
In-House Precision: Serum vs. Plasma – ACE Direct Bilirubin Reagent. Precision (SD, %CV) was evaluated at ACE, Alera, and Axcel systems for serum (low, mid, high levels) and plasma (low, mid, high levels).
For ACE, serum precision ranged from 0.04, 24.5% (within-run) to 0.05, 30.0% (total) for low serum. Plasma precision ranged from 0.03, 26.6% (within-run) to 0.03, 26.6% (total) for low plasma.
Similar detailed precision results are provided for Alera and Axcel systems.
In-House Precision: Serum vs. Plasma – ACE Total Bilirubin Reagent. Precision (SD, %CV) was evaluated at ACE, Alera, and Axcel systems for serum (low, mid, high levels) and plasma (low, mid, high levels).
For ACE, serum precision ranged from 0.07, 21.3% (within-run) to 0.07, 21.3% (total) for low serum. Plasma precision ranged from 0.04, 20.3% (within-run) to 0.05, 21.3% (total) for low plasma.
Similar detailed precision results are provided for Alera and Axcel systems.
In-House Precision: Serum vs. Plasma -- ACE Magnesium Reagent. Precision (SD, %CV) was evaluated at ACE, Alera, and Axcel systems for serum (low, mid, high levels) and plasma (low, mid, high levels).
For ACE, serum precision ranged from 0.10, 5.1% (within-run) to 0.12, 5.9% (total) for low serum. Plasma precision ranged from 0.08, 4.7% (within-run) to 0.11, 6.2% (total) for low plasma.
Similar detailed precision results are provided for Alera and Axcel systems.
In-House Matrix Comparison: Serum vs. Plasma – ACE CO2-LC Reagent.
- ACE: 53 pairs, range 4.9-47.9 mEq/L. Slope: 1.031, Intercept: -1.03, Correlation: 0.9922, Std. Error Est: 1.13.
- ACE Alera: 54 pairs, range 4.7-48.2 mEq/L. Slope: 1.000, Intercept: -0.09, Correlation: 0.9955, Std. Error Est: 0.86.
- ACE Axcel: 51 pairs, range 5.5-47.9 mEq/L. Slope: 0.988, Intercept: -0.35, Correlation: 0.9889, Std. Error Est: 1.12.
In-House Matrix Comparison: Serum vs. Plasma – ACE Direct Bilirubin Reagent.
- ACE: 102 pairs, range 0.1-10.8 mg/dL. Slope: 1.021, Intercept: 0.00, Correlation: 0.9982, Std. Error Est: 0.10.
- ACE Alera: 101 pairs, range 0.1-11.0 mg/dL. Slope: 1.005, Intercept: 0.01, Correlation: 0.9978, Std. Error Est: 0.11.
- ACE Axcel: 56 pairs, range 0.1-13.1 mg/dL. Slope: 1.004, Intercept: 0.00, Correlation: 0.9983, Std. Error Est: 0.16.
In-House Matrix Comparison: Serum vs. Plasma – ACE Total Bilirubin Reagent.
- ACE: 102 pairs, range 0.1-37.2 mg/dL. Slope: 1.017, Intercept: 0.01, Correlation: 0.9996, Std. Error Est: 0.15.
- ACE Alera: 102 pairs, range 0.2-36.7 mg/dL. Slope: 1.020, Intercept: 0.00, Correlation: 0.9993, Std. Error Est: 0.20.
- ACE Axcel: 56 pairs, range 0.2-35.5 mg/dL. Slope: 1.008, Intercept: 0.00, Correlation: 0.9995, Std. Error Est: 0.22.
In-House Matrix Comparison: Serum vs. Plasma – ACE Magnesium Reagent.
- ACE: 52 pairs, range 0.4-5.9 mg/dL. Slope: 0.950, Intercept: 0.09, Correlation: 0.9765, Std. Error Est: 0.19.
- ACE Alera: 101 pairs, range 1.0-5.9 mg/dL. Slope: 0.986, Intercept: 0.05, Correlation: 0.9817, Std. Error Est: 0.15.
- ACE Axcel: 55 pairs, range 1.2-5.8 mg/dL. Slope: 0.986, Intercept: 0.025, Correlation: 0.9892, Std. Error Est: 0.125.
Precision - POL: Precision studies at 3 Point-of-Care (POL) sites for ACE Alera Clinical Chemistry System. ACE system was also tested concurrently and comparable precision was obtained. Detailed data for CO2-LC, Direct Bilirubin, Total Bilirubin, and Magnesium are provided showing mean, within-run SD and %CV, and total SD and %CV for various samples at In-House and 3 POL sites.
Method Comparison - POL on ACE: Comparison of In-House ACE vs. POL ACE systems for CO2-LC, Direct Bilirubin, Total Bilirubin, and Magnesium.
- CO2-LC: n=45-46, Range 3.6-46.2. Regression equations provided, correlations ranged from 0.9530 to 0.9908.
- Direct Bilirubin: n=49, Range 0.1-12.4. Regression equations provided, correlations ranged from 0.9984 to 0.9986.
- Total Bilirubin: n=48-50, Range 0.2-39.3. Regression equations provided, correlations ranged from 0.9995 to 0.9998.
- Magnesium: n=51-52, Range 0.6-6.1. Regression equations provided, correlations ranged from 0.9902 to 0.9927.
Method Comparison - POL on ACE Alera: Comparison of In-House ACE vs. POL Alera systems for CO2-LC, Direct Bilirubin, Total Bilirubin, and Magnesium.
- CO2-LC: n=45-46, Range 2.0-46.0. Regression equations provided, correlations ranged from 0.9767 to 0.9903.
- Direct Bilirubin: n=51, Range 0.1-12.4. Regression equations provided, correlations ranged from 0.9984 to 0.9991.
- Total Bilirubin: n=50, Range 0.2-39.4. Regression equations provided, correlations ranged from 0.9991 to 0.9998.
- Magnesium: n=50, Range 0.7-5.9. Regression equations provided, correlations ranged from 0.9870 to 0.9930.
Detection Limits - ACE Alera Clinical Chemistry System: LoB, LoD, and LoQ values are provided for CO2, DBILI, TBILI, and MG.
- CO2: LoB=1.27, LoD=1.97, LoQ=3.03 mEq/L
- DBILI: LoB=0.06, LoD=0.08, LoQ=0.12 mg/dL
- TBILI: LoB=0.11, LoD=0.14, LoQ=0.14 mg/dL
- MG: LoB=0.26, LoD=0.37, LoQ=0.37 mg/dL
Linearity - ACE Alera Clinical Chemistry System: Linear range and linear regression equations are provided for CO2, DBILI, TBILI, and MG.
- CO2: Linear to 50 mEq/L, y=1.006x + 0.01
- DBILI: Linear to 14.0 mg/dL, y=1.015x + 0.16
- TBILI: Linear to 40.0 mg/dL, y=1.004x + 0.03
- MG: Linear to 6.1 mg/dL, y=0.959x + 0.27
Interferences - ACE Alera Clinical Chemistry System: Interference studies for Icterus, Hemolysis, Lipemia (Intralipid)/Triglycerides, and Ascorbic Acid for CO2, DBili, TBili, and MG. No significant interference was observed at or below specified concentrations for all interferents and analytes.
Precision - ACE Alera Clinical Chemistry System: Precision (Mean, Within-Run SD, %CV, Total SD, %CV) data for CO2, DBILI, TBILI, and MG at low, mid, and high levels.
- CO2: Low (12.8 mEq/L): 0.55, 4.3% (within-run); 1.20, 9.4% (total).
- DBILI: Low (0.3 mg/dL): 0.02, 5.3% (within-run); 0.02, 6.5% (total).
- TBILI: Low (0.5 mg/dL): 0.03, 5.7% (within-run); 0.04, 8.5% (total).
- MG: Low (1.6 mg/dL): 0.07, 4.3% (within-run); 0.08, 5.1% (total).
Method Comparison - ACE Alera Clinical Chemistry System: In-House ACE (x) vs. In-House ACE Alera (y) for analytes.
- CO2: n=46, Slope=0.981, Intercept=-0.6, Correlation=0.9974.
- DBILI: n=49, Slope=0.998, Intercept=0.00, Correlation=0.99999.
- TBILI: n=49, Slope=1.001, Intercept=0.00, Correlation=1.000.
- MG: n=50, Slope=0.960, Intercept=0.12, Correlation=0.9906.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Alfa Wassermann ACE Carbon Dioxide (CO2-LC) Reagent, ACE Direct Bilirubin Reagent, ACE Total Bilirubin Reagent, and ACE Magnesium Reagent (K931786)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1160 Bicarbonate/carbon dioxide test system.
(a)
Identification. A bicarbonate/carbon dioxide test system is a device intended to measure bicarbonate/carbon dioxide in plasma, serum, and whole blood. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.(b)
Classification. Class II.
0
. K123953
510(k) SUMMARY
·
·
MAY 2 2013
| 510(k) Owner: | Alfa Wassermann Diagnostic Technologies, LLC
4 Henderson Drive
West Caldwell, NJ 07006 | | |
|------------------------|----------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|--|
| Contact: | Hkatz@AlfaWassermannUS.com
Hyman Katz, Ph.D.
Phone: 973-852-0158
Fax: 973-852-0237 | | |
| Date Summary Prepared: | April 25, 2013 | | |
| Device: | Trade Name: | ACE Carbon Dioxide (CO2-LC) Reagent | |
| | Classification: | Class 2 | |
| | Common/Classification Name: | Enzymatic, Carbon-Dioxide
(21 C. F.R. § 862.1160)
Product Code KHS | |
| | Trade Name: | ACE Direct Bilirubin Reagent | |
| | Classification: | Class 2 | |
| | Common/Classification Name: | Diazo Colorimetry, Bilirubin
(21 C. F.R. § 862.1110)
Product Code CIG | |
| | Trade Name: | ACE Total Bilirubin Reagent | |
| | Classification: | Class 2 | |
| | Common/Classification Name: | Diazo Colorimetry, Bilirubin
(21 C. F.R. § 862.1110)
Product Code CIG | |
| | Trade Name: | ACE Magnesium Reagent | |
| | Classification: | Class 1, reserved | |
| | Common/Classification Name: | Photometric Method, Magnesium
(21 C. F.R. § 862.1495)
Product Code JGJ | |
1
| Predicate
Devices: | Alfa Wassermann ACE Carbon Dioxide (CO2-LC) Reagent, ACE Direct Bilirubin
Reagent, ACE Total Bilirubin Reagent, and ACE Magnesium Reagent
(K931786) | Intended Use: | Indications for Use: |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Descriptions: | In the ACE Carbon Dioxide (CO2-LC) Reagent assay, serum carbon dioxide (in the
form of bicarbonate) reacts with phosphoenolpyruvate in the presence of
phosphoenolpyruvate carboxylase and magnesium to yield oxaloacetic acid and
phosphate. In the presence of malate dehydrogenase, the reduced cofactor is oxidized by
oxaloacetic acid. The reduced cofactor absorbs strongly at 408 nm whereas its oxidized
form does not. The rate of decrease in absorbance, monitored bichromatically at 408
nm/692 nm, is proportional to the carbon dioxide content of the sample.
In the ACE Direct Bilirubin Reagent assay, sodium nitrite added to sulfanilic acid forms
diazotized sulfanilic acid. Bilirubin glucuronide in serum reacts with diazotized
sulfanilic acid to form azobilirubin, which absorbs strongly at 554 nm. The increase in
absorbance, measured bichromatically at 554 nm/692 nm, one minute after sample addi-
tion, is directly proportional to the direct bilirubin concentration.
In the ACE Total Bilirubin Reagent assay, sodium nitrite, when added to sulfanilic acid,
forms diazotized sulfanilic acid. Bilirubin in serum reacts with diazotized sulfanilic acid
to form azobilirubin, which absorbs strongly at 554 nm. The inclusion of dimethyl
sulfoxide (DMSO) in the reagent as an accelerator causes both direct and indirect
bilirubin to react rapidly. The increase in absorbance, measured bichromatically at 554 nm/692 nm, is directly proportional to the total bilirubin concentration in the sample.
Magnesium ions in serum react with Xylidyl blue-1 in an alkaline medium to produce a
red complex which is measured bichromatically at 525 nm/692 nm. The intensity of
color produced is directly proportional to the magnesium concentration in the sample.
EGTA prevents calcium interference by preferential chelation of calcium present in the
sample. A surfactant system is included to remove protein interference. | | The ACE Carbon Dioxide (CO2-LC) Reagent is intended for the quantitative
determination of carbon dioxide concentration in serum and lithium heparin plasma
using the ACE, ACE Alera®, and ACE Axcel Clinical Chemistry Systems.
Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of
numerous potentially serious disorders associated with changes in body acid-base
balance. This test is intended for use in clinical laboratories and physician office
laboratories. For in vitro diagnostic use only. |
| | The ACE Direct Bilirubin Reagent is intended for the quantitative determination of
direct bilirubin concentration in serum and lithium heparin plasma using the ACE,
ACE Alera, and ACE Axcel Clinical Chemistry Systems. Measurements of the levels of
bilirubin, an organic compound formed during the normal and abnormal destruction of
red blood cells, is used in the diagnosis and treatment of liver, hemolytic, hematological
and metabolic disorders, including hepatitis and gall bladder block. This test is intended
for use in clinical laboratories and physician office laboratories. For in vitro diagnostic
use only | | |
| | The ACE Total Bilirubin Reagent is intended for the quantitative determination of total
bilirubin concentration in serum and lithium heparin plasma using the ACE, ACE
Alera and ACE Axcel Clinical Chemistry System. Measurements of the levels of
bilirubin, an organic compound formed during the normal and abnormal destruction of
red blood cells is used in the diagnosis and treatment of liver, hemolytic, hematological
and metabolic disorders, including hepatitis and gall bladder block. This test is intended
for use in clinical laboratories and physician office laboratories. For in vitro diagnostic
use only. | | |
| | The ACE Magnesium Reagent is intended for the quantitative determination of
magnesium in serum and lithium heparin plasma using the ACE, ACE Alera and
ACE Axcel Clinical Chemistry Systems. Magnesium measurements are used in the
diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of
magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium).
This test is intended for use in clinical laboratories and physician office laboratories. For
in vitro diagnostic use only. | | |
100 - 100 -
and the comments of the comments of
and the comments of the comments of the comments of the comments of
2
3
| Technological
Characteristics: | The ACE Carbon Dioxide (CO2-LC) Reagent consists of a single reagent bottle. The
reagent contains Phosphoenolpyruvate, nicotinamide adenine dinucleotide, analog,
reduced, phosphoenol pyruvate carboxylase and malate dehydrogenase. |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The ACE Direct Bilirubin Reagent is composed of two reagent bottles (Direct Bilirubin
Reagent and Sodium Nitrite Reagent). The reagents contain Sulfanilic Acid,
hydrochloric acid, and sodium nitrite. |
| | The ACE Total Bilirubin Reagent is composed of two reagent bottles (Total Bilirubin
Reagent and Sodium Nitrite Reagent). The reagents contain sulfanilic acid, hydrochloric
Acid, DMSO and sodium Nitrite. |
| | The ACE Magnesium Reagent is composed of a single reagent bottle. The reagent
contains Xylidyl blue-1 and EGTA. |
. . .
| Device
Comparison
with Predicate | Comparison of similarities and differences with predicate
device
ACE Carbon Dioxide (CO2-LC) Reagent | | |
|----------------------------------------|------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|----------------------------------|
| | CO2-LC | Candidate Device | Predicate
K9317
(ACE CO2 |
| | Intended Use | The ACE Carbon Dioxide (CO2-LC) Reagent is
intended for the quantitative determination of carbon
dioxide concentration. | Same |
| | Platforms | ACE, ACE Alera®, and ACE Axcel Clinical Chemistry
Systems | ACE Clinical
Chemistry System |
| | Method | Photometric | Same |
| | Calibration Stability | 7 days | Same |
| | On-Board Stability | 14 days | Same |
| | Sample Type | Serum and lithium heparin plasma | Serum |
| | Sample Volume | 6 µL | Same |
| | Reaction Volume | 156 µL | Same |
| | Expected Values | 23 - 29 mEq/L | Same |
| | Measuring Range | 4 - 50 mEq/L | Same |
| | Sample Stability | Separated from cells, carbon dioxide is stable for 7 | Same |
4
| Device
Comparison
| with Predicate | ACE Direct Bilirubin Reagent | ||
|---|---|---|---|
| Direct Bilirubin | Candidate Device | Predicate Device | |
| K931786 | |||
| (ACE Direct | |||
| Bilirubin) | |||
| Intended Use/ | |||
| Indications for Use | The ACE Direct Bilirubin Reagent is intended for the | ||
| quantitative determination of direct bilirubin | |||
| concentration. | Same | ||
| Platforms | ACE, ACE Alera®, and ACE Axcel Clinical | ||
| Chemistry Systems | ACE Clinical | ||
| Chemistry System | |||
| Method | Photometric | Same | |
| Calibration Stability | 30 days | Same | |
| On-Board Stability | 30 days | Same | |
| Sample Type | Serum and lithium heparin plasma | Serum | |
| Sample Volume | 20 µL | Same | |
| Reaction Volume | 355 µL | Same | |
| Expected Values | Sincerely yours, Carol C. Benson -S |
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
for
Enclosure
22
Indications for Use
510(k) Number (if known): K123953
| Device Name: | ACE Carbon Dioxide (CO2-LC) Reagent |
|---|---|
| Indications for Use: | The ACE Carbon Dioxide (CO2-LC) Reagent is intended for the quantitative determination of carbon dioxide concentration in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. |
| Device Name: | ACE Direct Bilirubin Reagent |
| Indications for Use: | The ACE Direct Bilirubin Reagent is intended for the quantitative determination of direct bilirubin concentration in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Measurements of the levels of bilirubin, an organic |
compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic, hematological and metabolic disorders, including hepatitis and gall bladder block. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only
Prescription Use X (21 CFR Part 801 Subpart D) AND/OR
Over-The-Counter Use. (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Devices or Radiological Health (OIR)
YungW.Chan -S
Division Sign-Off Office of In Vitro Devices or Radiological Health 510(k) K123953
Page 1 of 2
23
Indications for Use
510(k) Number (if known): K123953
Device Name: ACE Total Bilirubin Reagent
Indications for Use: The ACE Total Bilirubin Reagent is intended for the quantitative determination of total bilirubin concentration in serum and lithium heparin plasma using the ACE, ACE Alera and ACE Axcel Clinical Chemistry System. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic, hematological and metabolic disorders, including hepatitis and gall bladder block. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
Device Name: ACE Magnesium Reagent
Indications for Use: The ACE Magnesium Reagent is intended for the quantitative determination of magnesium in serum and lithium heparin plasma using the ACE, ACE Alera and ACE Axcel Clinical Chemistry Systems. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium). This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
Prescription Use X (21 CFR Part 801 Subpart D) AND/OR
Over-The-Counter Use. (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Devices or Radiological Health (OIR)
YungW.Chan -S
Division Sign-Off Office of In Vitro Devices or Radiological Health 510(k) = K123953
Page 2 of 2