(246 days)
Not Found
No
The device description details a chemical reaction and photometric measurement for determining enzyme activity, which is a standard laboratory technique and does not involve AI/ML. There is no mention of AI, ML, or related concepts in the document.
No.
This device is an in vitro diagnostic reagent used to measure enzyme activity in serum for diagnostic purposes only, not for direct treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the measurements obtained from these reagents are "used in the diagnosis and treatment of certain liver diseases" and "heart diseases," and that the test is "For in vitro diagnostic use only."
No
The device description clearly outlines chemical reactions and measurements of absorbance, indicating a physical reagent and a clinical chemistry system are involved, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use only."
- Intended Use: The reagents are intended for the quantitative determination of specific enzyme activities (ALT, AST, γ-GT) in serum. Serum is a biological sample taken from the human body.
- Diagnostic Purpose: The measurements are used in the "diagnosis and treatment of certain liver diseases" and "heart diseases." This clearly indicates a diagnostic purpose.
- Clinical Setting: The intended use is in "clinical laboratories or physician office laboratories," which are settings where in vitro diagnostic tests are performed.
- Mechanism: The "Device Description" details the biochemical reactions that occur when the reagents interact with the serum sample to measure the enzyme activity. This is characteristic of an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The ACE ALT Reagent is intended for the quantitative determination of alanine aminotransferase activity in serum using the ACE Axcel Clinical Chemistry System. Alanine aminotransferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
The ACE AST Reagent is intended for the quantitative determination of aspartate aminotransferase activity in serum using the ACE Axcel Clinical Chemistry System. Measurements of aspartate aminotransferase are used in the diagnosis and treatment of certain types of liver and heart disease. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
The ACE γ-GT Reagent is intended for the quantitative determination of gamma-glutamyltransferase activity in serum using the ACE Axcel Clinical Chemistry System. Gamma-glutamyltransferase measurements are used in the diagnosis and treatment of liver diseases such as alcoholic cirrhosis and primary and secondary liver tumors. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
Product codes (comma separated list FDA assigned to the subject device)
CIT, CKA, JPZ
Device Description
In the ACE ALT Reagent assay, alanine aminotransferase in serum converts the L-alanine and α-ketoglutarate substrates in the reagent to L-glutamate and pyruvate. Lactate dehydrogenase (LDH) catalyzes the oxidation of the reduced cofactor to the cofactor. The rate of conversion of the reduced cofactor to the cofactor can be determined by monitoring the decrease in absorbance bichromatically at 340 nm/647 nm. This rate of conversion from the reduced cofactor to the cofactor is a function of the activity of ALT in the sample.
In the ACE AST Reagent assay, aspartate aminotransferase in serum converts the L-aspartate and α-ketoglutarate in the reagent to oxalacetate and L-glutamate. The oxalacetate undergoes reduction with simultaneous oxidation of NADH to NAD+ in the malate dehydrogenase catalyzed indicator reaction. NADH absorbs strongly at 340 nm, whereas NAD+ does not. Therefore, the rate of conversion of NADH to NAD+ can be determined by monitoring the decrease in absorbance bichromatically at 340 nm/647 nm. This rate of conversion from NADH to NAD+ is a function of the activity of AST in the sample. Lactate dehydrogenase is added to prevent interference from endogenous pyruvate, which is normally present in serum.
In the ACE γ-GT Reagent assay, γ-GT in serum catalyzes the transfer of the γ-glutamyl group from L-γ-glutamyl-3-carboxy-4-nitroanilide to glycylglycine in the reagent. The product, 5-amino-2-nitrobenzoate, absorbs strongly at 408 nm. The rate of increase in absorbance, monitored bichromatically at 408 nm/486 nm, is directly proportional to the γ-GT activity in the sample.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Clinical laboratories or physician office laboratories.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance data for the Alfa Wassermann ACE Reagents run on the Alfa Wassermann ACE Axcel Clinical Chemistry System included precision, accuracy, and detection limit data.
ACE ALT Reagent
Precision: In testing conducted at four ALT levels for 22 days, the within-run CV ranged from 0.8 to 6.9%, and total CV ranged from 1.1 to 6.9% In precision studies at three separate Physician Office Laboratory (POL) sites over 5 days, the within-run CV ranged from 0.8 to 8.7% and total CV ranged from 1.3 to 8.7%.
Accuracy: In the correlation study, 102 samples with ALT values ranging from 4 to 472 U/L were assayed on the Alfa Wassermann ACE Axcel Clinical Chemistry System (y) and the Alfa Wassermann ACE Clinical Chemistry System (x). Least squares regression analysis yielded a correlation coefficient of 0.9996, a standard error estimate of 2.4, a confidence interval slope of 1.035 to 1.047, and a confidence interval intercept of -0.3 to 0.9. In patient correlation studies at three separate POL sites, using the Alfa Wassermann ACE Axcel Clinical Chemistry System (y) and the Alfa Wassermann ACE Clinical Chemistry System (x), least-squares regression analysis yielded correlation coefficients of 0.9997 to 0.9999, standard error estimates of 2.4 to 3.1, confidence interval slopes of 1.009 to 1.035, and a confidence interval intercepts of -1.1 to 2.4.
Detection limit: The detection limit was 3.1 U/L.
ACE AST Reagent
Precision: In testing conducted at four AST levels for 22 days, the within-run CV ranged from 0.9 to 7.1%, and total CV ranged from 1.4 to 8.5%. In precision studies at three separate Physician Office Laboratory (POL) sites over 5 days, the within-run CV ranged from 1.1 to 11.3% and total CV ranged from 1.2 to 11.3%.
Accuracy: In the correlation study, 117 samples with AST values ranging from 8 to 440 U/L were assayed on the Alfa Wassermann ACE Axcel Clinical Chemistry System (y) and the Alfa Wassermann ACE Clinical Chemistry System (x). Least squares regression analysis yielded a correlation coefficient of 0.9996, a standard error estimate of 2.2, a confidence interval slope of 1.002 to 1.012, and a confidence interval intercept of 1.9 to 2.8. In patient correlation studies at three separate POL sites, using the Alfa Wassermann ACE Axcel Clinical Chemistry System (y) and the Alfa Wassermann ACE Clinical Chemistry System (x), least-squares regression analysis yielded correlation coefficients of 0.9996 to 0.9998, standard error estimates of 2.5 to 2.9, confidence interval slopes of 1.005 to 1.038, and a confidence interval intercepts of -1.4 to 2.1.
Detection limit: The detection limit was 1.5 U/L.
ACE γ-GT Reagent.
Precision: In testing conducted at four γ-GT levels for 22 days, the within-run CV ranged from 1.0 to 3.0%, and total CV ranged from 1.1 to 6.1%. In precision studies at three separate Physician Office Laboratory (POL) sites over 5 days, the within-run CV ranged from 0.7 to 12.4% and total CV ranged from 1.3 to 13.0%.
Accuracy: In the correlation study, 128 samples with γ-GT values ranging from 7 to 902 U/L were assayed on the Alfa Wassermann ACE Axcel Clinical Chemistry System (y) and the Alfa Wassermann ACE Clinical Chemistry System (x). Least squares regression analysis yielded a correlation coefficient of 0.9998, a standard error estimate of 3.4, a confidence interval slope of 0.981 to 0.988, and a confidence interval intercept of -0.6 to 0.8. In patient correlation studies at three separate POL sites, using the Alfa Wassermann ACE Axcel Clinical Chemistry System (y) and the Alfa Wassermann ACE Clinical Chemistry System (x), least-squares regression analysis yielded correlation coefficients of 0.9992 to 0.9999, standard error estimates of 3.6to 8.8, confidence interval slopes of 0.967 to 1.053, and a confidence interval intercepts of -1.7 to 4.8.
Detection limit: The detection limit was 2.7 U/L.
Key results: Based on the foregoing data, the device is safe and effective. These data also indicate substantial equivalence to the predicate device.
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.
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
§ 862.1030 Alanine amino transferase (ALT/SGPT) test system.
(a)
Identification. An alanine amino transferase (ALT/SGPT) test system is a device intended to measure the activity of the enzyme alanine amino transferase (ALT) (also known as a serum glutamic pyruvic transaminase or SGPT) in serum and plasma. Alanine amino transferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
0
K113.382
510(k) SUMMARY
JUL 1 9 2012
.
ACE ALT, AST, y-GT Reagents on the ACE Axcel Clinical Chemistry System
| 510(k) Owner: | Alfa Wassermann Diagnostic Technologies, LLC
4 Henderson Drive
West Caldwell, NJ 07006 | |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| Contact: | Hyman Katz, Ph.D.
Phone: 973-852-0158
Fax: 973-852-0237 | |
| Date Summary Prepared: | July 13, 2012 | |
| Device: | Trade Name: | ACE ALT Reagent |
| | Classification: | Class 1 |
| | Common/Classification Name: | NADH Oxidation/NAD Reduction, ALT/SGPT
(21 C.F.R. § 862.1030)
Product Code CKA |
| | Trade Name: | ACE AST Reagent |
| | Classification: | Class 2 |
| | Common/Classification Name: | NADH Oxidation/NAD Reduction, AST/SGOT
(21 C.F.R. § 862.1100)
Product Code CIT |
| | Trade Name: | ACE γ-GT Reagent |
| | Classification: | Class 1 |
| | Common/Classification Name: | Colorimetric Method, Gamma-Glutamyl Transpeptidase
(21 C.F.R. § 862.1360)
Product Code JPZ |
| Predicate Devices: | Manufacturer for analyzer/reagent system predicate:
Alfa Wassermann ACE plus ISE/Clinical Chemistry System
ACE Reagents (K931786) | |
1
| Device
Descriptions: | In the ACE ALT Reagent assay, alanine aminotransferase in serum converts the L-
alanine and α-ketoglutarate substrates in the reagent to L-glutamate and pyruvate.
Lactate dehydrogenase (LDH) catalyzes the oxidation of the reduced cofactor to the
cofactor. The rate of conversion of the reduced cofactor to the cofactor can be
determined by monitoring the decrease in absorbance bichromatically at 340
nm/647 nm. This rate of conversion from the reduced cofactor to the cofactor is a
function of the activity of ALT in the sample.
In the ACE AST Reagent assay, aspartate aminotransferase in serum converts the L-
aspartate and α-ketoglutarate in the reagent to oxalacetate and L-glutamate. The
oxalacetate undergoes reduction with simultaneous oxidation of NADH to NAD+ in
the malate dehydrogenase catalyzed indicator reaction. NADH absorbs strongly at
340 nm, whereas NAD+ does not. Therefore, the rate of conversion of NADH to
NAD+ can be determined by monitoring the decrease in absorbance bichromatically
at 340 nm/647 nm. This rate of conversion from NADH to NAD+ is a function of
the activity of AST in the sample. Lactate dehydrogenase is added to prevent
interference from endogenous pyruvate, which is normally present in serum.
In the ACE γ-GT Reagent assay, γ-GT in serum catalyzes the transfer of the γ-
glutamyl group from L-γ-glutamyl-3-carboxy-4-nitroanilide to glycylglycine in the
reagent. The product, 5-amino-2-nitrobenzoate, absorbs strongly at 408 nm. The rate
of increase in absorbance, monitored bichromatically at 408 nm/486 nm, is directly
proportional to the γ-GT activity in the sample. |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | Indications for Use: |
| | The ACE ALT Reagent is intended for the quantitative determination of alanine
aminotransferase activity in serum using the ACE Axcel Clinical Chemistry System.
Alanine aminotransferase measurements are used in the diagnosis and treatment of
certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases. This test
is intended for use in clinical laboratories or physician office laboratories. For in
vitro diagnostic use only. |
| | The ACE AST Reagent is intended for the quantitative determination of aspartate
aminotransferase activity in serum using the ACE Axcel Clinical Chemistry System.
Measurements of aspartate aminotransferase are used in the diagnosis and treatment
of certain types of liver and heart disease. This test is intended for use in clinical
laboratories or physician office laboratories. For in vitro diagnostic use only. |
| | The ACE γ-GT Reagent is intended for the quantitative determination of gamma-
glutamyltransferase activity in serum using the ACE Axcel Clinical Chemistry
System. Gamma-glutamyltransferase measurements are used in the diagnosis and
treatment of liver diseases such as alcoholic cirrhosis and primary and secondary
liver tumors. This test is intended for use in clinical laboratories or physician office
laboratories. For in vitro diagnostic use only. |
| | |
| Technological
Characteristics: | The ACE ALT Reagent consists of two reagent bottles (Substrate and Coenzyme).
The reagents contain L-alanine, α-ketoglutarate, nicotinamide adenine dinucleotide,
reduced (NADH), lactate dehydrogenase and Tris buffer. |
| | The ACE AST Reagent consists of two reagent bottles (Substrate and Coenzyme).
The reagents contain L-aspartate, α-ketoglutarate, nicotinamide adenine
dinucleotide, reduced (NADH), malate dehydrogenase, lactate dehydrogenase and
Tris buffer. |
| | The ACE Y-GT Reagent consists of two reagent bottles (Buffer and Substrate). The
Buffer Reagent (R1) contains: glycylglycine. The Substrate Reagent (R2) contains:
L-y-glutamyl-3-carboxy-4-nitroanilide and buffer. |
| Performance
Data: | Performance data for the Alfa Wassermann ACE Reagents run on the Alfa
Wassermann ACE Axcel Clinical Chemistry System included precision, accuracy,
and detection limit data. |
| | ACE ALT Reagent |
| | Precision: In testing conducted at four ALT levels for 22 days, the within-run CV
ranged from 0.8 to 6.9%, and total CV ranged from 1.1 to 6.9% In precision studies
at three separate Physician Office Laboratory (POL) sites over 5 days, the within-
run CV ranged from 0.8 to 8.7% and total CV ranged from 1.3 to 8.7%. |
| | Accuracy: In the correlation study, 102 samples with ALT values ranging from 4 to
472 U/L were assayed on the Alfa Wassermann ACE Axcel Clinical Chemistry
System (y) and the Alfa Wassermann ACE Clinical Chemistry System (x). Least
squares regression analysis yielded a correlation coefficient of 0.9996, a standard
error estimate of 2.4, a confidence interval slope of 1.035 to 1.047, and a confidence
interval intercept of -0.3 to 0.9. In patient correlation studies at three separate POL
sites, using the Alfa Wassermann ACE Axcel Clinical Chemistry System (y) and the
Alfa Wassermann ACE Clinical Chemistry System (x), least-squares regression
analysis yielded correlation coefficients of 0.9997 to 0.9999, standard error
estimates of 2.4 to 3.1, confidence interval slopes of 1.009 to 1.035, and a
confidence interval intercepts of -1.1 to 2.4. |
| | Detection limit: The detection limit was 3.1 U/L. |
| | ACE AST Reagent |
| | Precision: In testing conducted at four AST levels for 22 days, the within-run CV
ranged from 0.9 to 7.1%, and total CV ranged from 1.4 to 8.5%. In precision studies
at three separate Physician Office Laboratory (POL) sites over 5 days, the within-
run CV ranged from 1.1 to 11.3% and total CV ranged from 1.2 to 11.3%. |
| | Accuracy: In the correlation study, 117 samples with AST values ranging from 8 to
440 U/L were assayed on the Alfa Wassermann ACE Axcel Clinical Chemistry
System (y) and the Alfa Wassermann ACE Clinical Chemistry System (x). Least
squares regression analysis yielded a correlation coefficient of 0.9996, a standard
error estimate of 2.2, a confidence interval slope of 1.002 to 1.012, and a confidence |
| | interval intercept of 1.9 to 2.8. In patient correlation studies at three separate POL
sites, using the Alfa Wassermann ACE Axcel Clinical Chemistry System (y) and the
Alfa Wassermann ACE Clinical Chemistry System (x), least-squares regression
analysis yielded correlation coefficients of 0.9996 to 0.9998, standard error
estimates of 2.5 to 2.9, confidence interval slopes of 1.005 to 1.038, and a
confidence interval intercepts of -1.4 to 2.1. |
| | Detection limit: The detection limit was 1.5 U/L. |
| | ACE y-GT Reagent. |
| | Precision: In testing conducted at four y-GT levels for 22 days, the within-run CV
ranged from 1.0 to 3.0%, and total CV ranged from 1.1 to 6.1%. In precision studies
at three separate Physician Office Laboratory (POL) sites over 5 days, the within-
run CV ranged from 0.7 to 12.4% and total CV ranged from 1.3 to 13.0%. |
| | Accuracy: In the correlation study, 128 samples with y-GT values ranging from 7 to
902 U/L were assayed on the Alfa Wassermann ACE Axcel Clinical Chemistry
System (y) and the Alfa Wassermann ACE Clinical Chemistry System (x). Least
squares regression analysis yielded a correlation coefficient of 0.9998, a standard
error estimate of 3.4, a confidence interval slope of 0.981 to 0.988, and a confidence
interval intercept of -0.6 to 0.8. In patient correlation studies at three separate POL
sites, using the Alfa Wassermann ACE Axcel Clinical Chemistry System (y) and the
Alfa Wassermann ACE Clinical Chemistry System (x), least-squares regression
analysis yielded correlation coefficients of 0.9992 to 0.9999, standard error
estimates of 3.6to 8.8, confidence interval slopes of 0.967 to 1.053, and a
confidence interval intercepts of -1.7 to 4.8. |
| | Detection limit: The detection limit was 2.7 U/L. |
| Conclusions: | Based on the foregoing data, the device is safe and effective. These data also
indicate substantial equivalence to the predicate device. |
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- September 19.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration
10903 New Hampshire Avenue Silver Spring, MD 20993
Alfa Wassermann Diagnostic Technologies, LLC c/o Hyman Katz, Ph.D. 4 Henderson Drive West Caldwell, NJ 07006
- K113382 Re: Trade Name: ACE AST Reagent JUL 1 9 2012 ACE ALT Reagent ACE y-GT Reagent Regulation Number: 21 CFR §862.1100 Regulation Name: Aspartate amino transferase (AST/SGOT) test system Regulatory Class: Class II Product Codes: CIT, CKA, JPZ Dated: June 19, 2012 Received: June 20, 2012
Dear Dr Katz:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Eederal 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
Image /page/4/Picture/9 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.
JUL 19 2012
5
Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you desire speently ad rive this Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, comation the orifical of in 1 around to "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrig's (OSB's) Division of Postmarket Surveillance at (301) 01160 of Sar remestions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical
Devices/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 Tou may of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm
Sincerely vours.
.
Counney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
Indications for Use
K113382 510(k) Number:
Device Name:
ACE ALT Reagent
Indications for Use:
The ACE ALT Reagent is intended for the quantitative determination of alanine aminotransferase activity in serum using the ACE Axcel Clinical Chemistry System. Alanine aminotransferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases. 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 Diagnostic Devices (OIVD)
Xandria Wms
Division Sign-Off Office of In vitro Diagnostic Device Evaluation and Safety
510(k) K 113382
Page 1 of 3
7
Indications for Use
K113382 510(k) Number:
Device Name:
ACE AST Reagent
Indications for Use:
Indications for Use: . The ACE AST Reagent is intended for the quantitative determination of aspartate aminotransferase activity in serum using the ACE Axcel Clinical Chemistry System. Measurements of aspartate aminotransferase are used in the diagnosis and treatment of certain types of liver and heart disease. 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 Diagnostic Devices (OIVD)
Tuandria Wms.
Division Sign-Off Office of In vitro Diagnostic Device Evaluation and Safety
510(k) k 1133 82
Page 2 of 9
8
Indications for Use
510(k) Number:
Device Name:
ACE y-GT Reagent
Indications for Use:
The ACE y-GT Reagent is intended for the quantitative determination of gamma-glutamyltransferase activity in serum using the ACE Axcel Clinical Chemistry System. Gamma-glutamyltransferase measurements are used in the diagnosis and treatment of liver diseases such as alcoholic cirrhosis and primary and secondary liver tumors. 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 Diagnostic Devices (OIVD)
Juandia Wms
Division Sign-Off
Office of In vitro Diagnostic Device Evaluation and Safety
510(k) K113382.
Page 3 of 3