(78 days)
Not Found
No
The device description details standard chemical assay methods and does not mention any AI or ML components. The performance studies focus on traditional analytical metrics.
No
Explanation: This device is an in vitro diagnostic reagent used for quantitative determination of certain enzymes/hormones in serum and plasma, which aids in the diagnosis and treatment of diseases. It does not directly provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the measurements are "used in the diagnosis and treatment of liver diseases," "diseases of the pancreas," and "thyroid diseases." Additionally, it mentions "For in vitro diagnostic use only," which confirms its purpose as a diagnostic device.
No
The device is a reagent kit used with specific clinical chemistry systems, which are hardware devices. The description focuses on the chemical reactions and performance characteristics of the reagents, not on software functionality as the primary medical device.
Yes, these devices are In Vitro Diagnostics (IVDs).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the reagents are "intended for the quantitative determination of [analyte] activity in serum and lithium heparin plasma" and that these measurements are "used in the diagnosis and treatment of [specific diseases]". This clearly indicates that the devices are used to examine specimens derived from the human body for the purpose of providing information for the diagnosis and treatment of disease.
- "For in vitro diagnostic use only": Each reagent's intended use statement concludes with "For in vitro diagnostic use only." This is a standard phrase used to identify devices intended for use outside of the living body for diagnostic purposes.
- Device Description: The device descriptions detail the chemical reactions and processes that occur when the reagents interact with the patient samples (serum and plasma) to measure the levels of the target analytes (gamma-glutamyltransferase, lipase, and total thyroxine). This is characteristic of an in vitro test.
- Intended User / Care Setting: The intended users are "clinical laboratories and physician office laboratories," which are settings where in vitro diagnostic testing is performed.
Based on these points, the ACE y-GT Reagent, ACE Lipase Reagent, and ACE T4 Reagent are all clearly intended and described as In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The ACE y-GT Reagent is intended for the quantitative determination of gamma-glutamyltransferase activity in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. 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 and physician office laboratories. For in vitro diagnostic use only.
The ACE Lipase Reagent is intended for the quantitative determination of lipase activity in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Lipase measurements are used in diagnosis and treatment of diseases of the pancreas such as acute pancreatitis and obstruction of the pancreatic duct. This test is intended for use in clinical laboratories and physician office laboratories. For in vitro diagnostic use only.
The ACE T4 Reagent is intended for the quantitative determination of total thyroxine (T4) in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Total thyroxine measurements are used in the diagnosis and treatment of thyroid diseases. This test is intended for use in clinical laboratories and physician office laboratories. For in vitro diagnostic use only.
Product codes (comma separated list FDA assigned to the subject device)
KLI, CHI, JPZ
Device Description
In the ACE γ-GT Reagent assay, γ-GT in serum or heparin plasma 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.
In the ACE Lipase Reagent Assay, lipase in serum or heparin plasma acts on a natural substrate, 1,2-diglyceride, to liberate 2-monoglyceride. This is hydrolyzed by monoglyceride lipase (a highly specific enzyme for monoglyceride) into glycerol and free fatty acid. Glycerol kinase acts on glycerol to form glycerol-3-phosphate, which is in turn acted on by glycerol-3-phosphate oxidase to generate hydrogen peroxide. Peroxidase converts the hydrogen peroxide, 4-Aminoantipyrine and TOOS (N-ethyl-N-(2-hydroxy-3-sulfopropyl)-m-toluidine) into a quinine dye. The rate of formation of the dye, determined bichromatically at an absorbance of 573 nm/692 nm, is proportional to the lipase activity in the sample.
The ACE T4 Assay is a homogeneous enzyme immunoassay using ready-to-use liquid ACE T4 Reagent. The assay uses 8-anilino-1-naphthalene sulfonic acid (ANS) to dissociate thyroxine from the plasma binding proteins. Using specific antibodies to thyroxine, this assay is based on the competition of glucose-6-phosphate dehydrogenase (G6PD) labeled thyroxine and the dissociated thyroxine in the sample for a fixed amount of specific antibody binding sites. In the absence of thyroxine from the sample, the thyroxine labeled G6PD in the second reagent is bound by the specific antibody in the first reagent, inhibiting the enzyme's activity. The enzyme G6PD catalyzes the oxidation of glucose-6-phosphate (G6P) with nicotinamide adenine dinucleotide (NADT) to form 6-phosphogluconate and reduced nicotinamide adenine dinucleotide (NADH). NADH strongly absorbs at 340 nm whereas NAD does not. The rate of conversion, determined by measuring the increase in absorbance bichromatically at 340 nm/505 nm during a fixed time interval, is directly proportional to the amount of thyroxine in the sample. The concentration of thyroxine is determined automatically by the ACE Clinical Chemistry Systems using a logarithmic calibration curve established with calibrators, which are provided separately.
Mentions image processing
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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
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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)
In-House Precision - Serum vs. Plasma - ACE γ-GT Reagent: Samples: Serum Low, Plasma Low, Serum Mid, Plasma Mid, Serum High, Plasma High. Systems: ACE, ACE Alera, ACE Axcel. Metrics: Mean, Within-Run (SD, %CV), Total (SD, %CV). Example for ACE: Serum Low (Mean 38, Within-Run 0.9 SD, 2.4% CV, Total 1.2 SD, 3.1% CV).
In-House Precision - Serum vs. Plasma - ACE Lipase Reagent: Samples: Serum Low, Plasma Low, Serum Mid, Plasma Mid, Serum High, Plasma High. Systems: ACE, ACE Alera, ACE Axcel. Metrics: Mean, Within-Run (SD, %CV), Total (SD, %CV). Example for ACE: Serum Low (Mean 47, Within-Run 1.7 SD, 3.6% CV, Total 3.2 SD, 6.7% CV).
In-House Precision: Serum vs. Plasma – ACE T4 Reagent: Samples: Serum Low, Plasma Low, Serum Mid, Plasma Mid, Serum High, Plasma High. Systems: ACE, ACE Alera, ACE Axcel. Metrics: Mean, Within-Run (SD, %CV), Total (SD, %CV). Example for ACE: Serum Low (Mean 7.7, Within-Run 0.17 SD, 2.2% CV, Total 0.35 SD, 4.5% CV).
In-House Matrix Comparison: Serum vs. Plasma – ACE γ-GT Reagent: Systems: ACE (100 pairs, 9 - 886 U/L), ACE Alera (97 pairs, 9 - 841 U/L), ACE Axcel (53 pairs, 10 - 910 U/L). Metrics: Slope, Intercept, Correlation, Std. Error Est, Confidence Interval Slope, Confidence Interval Intercept. Example for ACE: Slope: 0.972, Intercept: 1.5, Correlation: 0.9990.
In-House Matrix Comparison: Serum vs. Plasma – ACE Lipase Reagent: Systems: ACE (42 pairs, 16 - 642 U/L), ACE Alera (43 pairs, 19 - 640 U/L), ACE Axcel (62 pairs, 15 - 627 U/L). Metrics: Slope, Intercept, Correlation, Std. Error Est, Confidence Interval Slope, Confidence Interval Intercept. Example for ACE: Slope: 1.024, Intercept: -2.5, Correlation: 0.9992.
In-House Matrix Comparison: Serum vs. Plasma – ACE T4 Reagent: Systems: ACE (55 pairs, 2.0 - 19.3 µg/dL), ACE Alera (55 pairs, 1.9 - 18.6 µg/dL), ACE Axcel (55 pairs, 2.1 - 17.6 µg/dL). Metrics: Slope, Intercept, Correlation, Std. Error Est, Confidence Interval Slope, Confidence Interval Intercept. Example for ACE: Slope: 0.963, Intercept: 0.35, Correlation: 0.9847.
Precision - POL: Data for ACE and ACE Alera Clinical Chemistry Systems for γ-GT, Lipase, and T4. Samples are from In-House and POLs 1, 2, and 3 at different levels (1, 2, 3). Metrics: Mean, Within-Run (SD, %CV), Total (SD, %CV). Example for γ-GT, In-House, Sample 1 on ACE: Mean 19, Within-Run 0.9 SD, 4.6% CV, Total 1.7 SD, 9.2% CV.
Method Comparison - POL on ACE: Reagents: γ-GT, Lipase, T4. Comparison of In-House (x) vs. ACE POL 1, 2, 3 (y). Metrics: n, Range, Regression, Correlation, Std. Error Est, CI Slope, CI Intercept. Example for γ-GT, In-House vs. ACE POL 1: n=51, Range 15 to 866, Regression y = 0.964x + 0.7, Correlation 0.9997.
Method Comparison - POL on ACE Alera: Reagents: γ-GT, Lipase, T4. Comparison of In-House (x) vs. ACE Alera POL 1, 2, 3 (y). Metrics: n, Range, Regression, Correlation, Std. Error Est, CI Slope, CI Intercept. Example for γ-GT, In-House vs. ACE Alera POL 1: n=51, Range 15 to 866, Regression y = 0.950x + 1.9, Correlation 0.9998.
Detection Limits - ACE Alera Clinical Chemistry System: Reagents: γ-GT, Lipase, T4. Metrics: LOB (Limit of Blank), LOD (Limit of Detection), LOQ (Limit of Quantitation). Example for γ-GT: LOB 3 U/L, LOD 5 U/L, LOQ 7 U/L.
Linearity - ACE Alera Clinical Chemistry System: Reagents: γ-GT, Lipase, T4. Metrics: Low Level Tested, High Level Tested, Linear to, Linear Regression equation. Example for γ-GT: Low Level Tested 4 U/L, High Level Tested 993 U/L, Linear to 950 U/L, Linear Regression $y = 1.036x + 0.8$.
Interferences - ACE Alera Clinical Chemistry System: Interferents: Icterus, Hemolysis, Lipemia, Ascorbic Acid. Limits for no significant interference for γ-GT, Lipase, T4. Example for Icterus: 14.2 mg/dL for γ-GT.
Heterophile Interferences – ACE T4 on the ACE Alera Clinical Chemistry System: Heterophile: Human Anti-Mouse Antibody (HAMA), Rheumatoid Factor. No Clinically Interfering Condition at or below: 800 ng/mL for HAMA, 516 IU/mL for Rheumatoid Factor.
Cross-Reactivity – ACE T4 on the ACE Alera Clinical Chemistry System: Cross-Reactant: 3,3',5,5'- Tetraiodothyroacetic Acid, L-Thyroxine, D-Thyroxine. Metrics: Concentration Tested (µg/dL), % Cross-Reactivity. Example for 3,3',5,5'- Tetraiodothyroacetic Acid: 5 µg/dL, 18.4%.
Performance Data (Summary Table with Precision and Method Comparison): Precision for γ-GT, Lipase, T4 on ACE Alera at Low, Mid, High levels with Mean, Within-Run (SD, %CV), Total (SD, %CV). Method Comparison for γ-GT, Lipase, T4 (In-House ACE vs. In-House ACE Alera) with n, Range, Slope, Intercept, Correlation Coefficient, Std. Error, CI Slope.
Example Precision for γ-GT Low: Mean 29, Within-Run 1.0 SD, 3.4% CV, Total 1.3 SD, 4.7% CV.
Example Method Comparison for γ-GT: n=51, Range 15 to 866 U/L, Slope 0.975, Intercept 4.3, Correlation Coefficient 0.9999.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity, Specificity, PPV, NPV: Not Found.
Other key metrics provided include: Mean, Within-Run SD, Within-Run %CV, Total SD, Total %CV, Slope, Intercept, Correlation, Std. Error Est, Confidence Interval Slope, Confidence Interval Intercept, LOB, LOD, LOQ, % Cross-Reactivity.
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
§ 862.1700 Total thyroxine test system.
(a)
Identification. A total thyroxine test system is a device intended to measure total (free and protein bound) thyroxine (thyroid hormone) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
KIBISTS
510(k) SUMMARY
:
| 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 | AUG 1 4 2013 |
| Date Summary
Prepared: | August 5, 2013 | |
| Device: | 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 |
| | Trade Name: | ACE Lipase Reagent |
| | Classification: | Class 1 |
| | Common/Classification Name: | Lipase-Esterase, Enzymatic, Photometric, Lipase
(21 C. F.R. § 862.1465)
Product Code CHI |
| | Trade Name: | ACE T4 Reagent |
| | Classification: | Class 2 |
| | Common/Classification Name: | Enzyme Immunoassay, Non-Radiolabeled, Total
Thyroxine
(21 C. F.R. § 862.1700)
Product Code KLI |
| Predicate
Devices: | Manufacturer for reagent system predicates:
Alfa Wassermann ACE Clinical Chemistry System
and ACE Reagents (K930104, K981377, K113253, K113382, K113438, K113437) | |
| Device
Descriptions: | In the ACE γ-GT Reagent assay, γ-GT in serum or heparin plasma 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. | |
1
In the ACE Lipase Reagent Assay, lipase in serum or heparin plasma acts on a natural substrate, 1,2-diglyceride, to liberate 2-monoglyceride. This is hydrolyzed by monoglyceride lipase (a highly specific enzyme for monoglyceride) into glycerol and free fatty acid. Glycerol kinase acts on glycerol to form glycerol-3-phosphate, which is in turn acted on by glycerol-3-phosphate oxidase to generate hydrogen peroxide. Peroxidase converts the hydrogen peroxide, 4-Aminoantipyrine and TOOS (N-ethyl-N-(2-hydroxy-3-sulfopropyl)-m-toluidine) into a quinine dye. The rate of formation of the dye, determined bichromatically at an absorbance of 573 nm/692 nm, is proportional to the lipase activity in the sample.
The ACE T4 Assay is a homogeneous enzyme immunoassay using ready-to-use liquid ACE T4 Reagent. The assay uses 8-anilino-1-naphthalene sulfonic acid (ANS) to dissociate thyroxine from the plasma binding proteins. Using specific antibodies to thyroxine, this assay is based on the competition of glucose-6-phosphate dehydrogenase (G6PD) labeled thyroxine and the dissociated thyroxine in the sample for a fixed amount of specific antibody binding sites. In the absence of thyroxine from the sample, the thyroxine labeled G6PD in the second reagent is bound by the specific antibody in the first reagent, inhibiting the enzyme's activity. The enzyme G6PD catalyzes the oxidation of glucose-6-phosphate (G6P) with nicotinamide adenine dinucleotide (NADT) to form 6-phosphogluconate and reduced nicotinamide adenine dinucleotide (NADH). NADH strongly absorbs at 340 nm whereas NAD does not. The rate of conversion, determined by measuring the increase in absorbance bichromatically at 340 nm/505 nm during a fixed time interval, is directly proportional to the amount of thyroxine in the sample. The concentration of thyroxine is determined automatically by the ACE Clinical Chemistry Systems using a logarithmic calibration curve established with calibrators, which are provided separately.
2
| Intended Use: | Indications for Use: |
|---|---|
| The ACE y-GT Reagent is intended for the quantitative determination of gamma- | |
| glutamyltransferase activity in serum and lithium heparin plasma using the ACE, | |
| ACE Alera, and ACE Axcel Clinical Chemistry Systems. 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 and physician office laboratories. For in vitro diagnostic use only. | |
| The ACE Lipase Reagent is intended for the quantitative determination of lipase activity | |
| in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel | |
| Clinical Chemistry Systems. Lipase measurements are used in diagnosis and treatment | |
| of diseases of the pancreas such as acute pancreatitis and obstruction of the pancreatic | |
| duct. This test is intended for use in clinical laboratories and physician office | |
| laboratories. For in vitro diagnostic use only. | |
| The ACE T4 Reagent is intended for the quantitative determination of total thyroxine | |
| (T4) in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE | |
| Axcel Clinical Chemistry Systems. Total thyroxine measurements are used in the | |
| diagnosis and treatment of thyroid diseases. This test is intended for use in clinical | |
| laboratories and physician office laboratories. For in vitro diagnostic use only. | |
| Technological | |
| Characteristics: | The ACE y-GT Reagent consists of two reagent bottles (y-GT Buffer and y-GT |
| Substrate). The reagent contains L-y-glutamyl-3-carboxy-4-nitroanilide, glycylglycine | |
| and buffer. | |
| The ACE Lipase Reagent is composed of two reagent bottles (Lipase Reagent and | |
| Lipase Activator). The Lipase Reagent (R1) contains: 1,2-diglyceride, monoglyceride | |
| lipase, glycerol kinase, glycerol-3-phosphate oxidase, N-ethyl-N-(2-hydroxy-3- | |
| sulfopropyl)-m-toluidine, ATP, peroxidase, colipase, human serum albumin, ascorbate | |
| oxidase, cholic acid and buffer. The Lipase Activator contains: deoxycholate, 4- | |
| aminoantipyrene and buffer. | |
| The ACE T4 Reagent is composed of two reagent bottles (Antibody/Substrate Reagent | |
| and Enzyme Conjugate Reagent). The Antibody/Substrate Reagent (R1) contains: | |
| mouse monoclonal anti-thyroxine antibody, 8-anilino-1-naphthalene sulfonic acid, | |
| glucose-6-phosphate, nicotinamide adenine dinucleotide and Tris buffer. The Enzyme | |
| Conjugate Reagent (R2) contains: glucose-6-phosphate dehydrogenase labeled with | |
| thyroxine and Tris buffer. |
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Device Comparison with Predicate
Comparison of similarities and differences with predicate device
ACE y-GT Reagent
| γ-GT | Candidate Device | Predicate Device
K930104
(ACE γ-GT Reagent) |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|
| Intended
Use/Indications for
Use | The ACE γ-GT Reagent is intended.for
the quantitative determination of gamma-
glutamyltransferase activity. | Same |
| Platforms | ACE, ACE Alera® and ACE Axcel
Clinical Chemistry Systems | ACE Clinical Chemistry
System |
| Method | Photometric | Same |
| Calibration Stability | Not a calibrated test | Same |
| On Board Stability | 30 days | Same |
| Sample Type | Serum and lithium heparin plasma | Serum |
| Sample Volume | 5 μL | Same |
| Reaction Volume | 170 μL | Same |
| Expected values | Male: 13-68 U/L
Female: 11-48 U/L | Same |
| Measuring range | 7-950 U/L | Same |
| Sample Stability | Separated from cells, gamma-
glutamyltransferase is stable 7 days at
4-8°C and up to 1 year at -20°C. | Same |
4
| ACE Lipase Reagent | ||
|---|---|---|
| Lipase | Candidate Device | Predicate Device |
| K930104 | ||
| (ACE Lipase Reagent) | ||
| Intended | ||
| Use/Indications for | ||
| Use | The ACE Lipase Reagent is intended for | |
| the quantitative determination of lipase | ||
| activity. | Same | |
| Platforms | ACE, ACE Alera® and ACE Axcel | |
| Clinical Chemistry Systems | ACE Clinical Chemistry | |
| System | ||
| Method | Photometric | Same |
| Calibration Stability | 20 days | Same |
| On Board Stability | 20 days | Same |
| Sample Type | Serum and lithium heparin plasma | Serum |
| Sample Volume | 3 µL | Same |
| Reaction Volume | 263 µL | Same |
| Expected values |