(96 days)
The ACE Direct Total Iron-Binding Capacity (TIBC) Reagent is intended for the quantitative determination of total iron-binding capacity in serum using the ACE Alera Clinical Chemistry System. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia. This test is intended for use in clinical laboratories and physician office laboratories. For in vitro diagnostic use only.
The ACE Total Iron Reagent is intended for the quantitative determination of iron in serum using the ACE Alera Clinical Chemistry System. Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia, hemochromatosis (a disease associated with widespread deposit in the tissues of two iron-containing pigments, hemosiderin and hemofuscin, and characterized by pigmentation of the skin), and chronic renal disease. This test is intended for use in clinical laboratories and physician office laboratories. For in vitro diagnostic use only.
The ACE LDH-L Reagent is intended for the quantitative determination of lactate dehydrogenase activity in serum using the ACE Alera Clinical Chemistry System. Lactate dehydrogenase measurements are used in the diagnosis and treatment of liver diseases such as acute viral hepatitis, cirrhosis, and metastatic carcinoma of the liver, cardiac diseases such as myocardial infarction and tumors of the lung or kidneys. This test is intended for use in clinical laboratories and physician office laboratories. For in vitro diagnostic use only.
In the ACE Direct Total Iron-Binding Capacity (TIBC) Reagent assay, Direct TIBC Color Reagent, an acidic buffer containing an iron-binding dye and ferric chloride, is added to the serum sample. The low pH of Direct TIBC Color Reagent releases iron from transferrin. The iron then forms a colored complex with the dye. The colored complex at the end of the first step represents both the serum iron and excess iron already present in Direct TIBC Color Reagent. Direct TIBC Buffer, a neutral buffer, is then added, shifting the pH and resulting in a large increase in the affinity of transferrin for iron. The serum transferrin rapidly binds the iron by abstracting it from the dye-iron complex. The observed decrease in absorbance of the colored dye-iron complex is directly proportional to the total iron-binding capacity of the serum sample. The absorbance is measured at 647 nm.
In the ACE Total Iron Reagent assay, transferrin-bound iron in serum is released at an acidic pH and reduced from ferric to ferrous ions. These ions react with ferrozine to form a violet colored complex, which is measured bichromatically at 554 nm/692 nm. The intensity of color produced is directly proportional to the serum iron concentration.
In the ACE LDH-L Reagent assay, lactate dehydrogenase catalyzes the conversion of L-lactate to pyruvate. Nicotinamide adenine dinucleotide (NAD+) acts as an acceptor for the hydrogen ions released from the L-lactate and is converted to reduced nicotinamide adenine dinucleotide (NADH). NADH absorbs strongly at 340 nm whereas NAD+ does not. Therefore, the rate of conversion of NAD+ to NADH can be determined by monitoring the increase in absorbance bichromatically at 340 nm/647 nm. This rate of conversion from NAD+ to NADH is directly proportional to the lactate dehydrogenase activity in the sample.
The provided document describes in vitro diagnostic (IVD) reagents (ACE Direct Total Iron-Binding Capacity (TIBC) Reagent, ACE Total Iron Reagent, and ACE LDH-L Reagent) for use on the ACE Alera Clinical Chemistry System. The acceptance criteria and performance data presented relate to the analytical performance of these reagents/systems, specifically their ability to accurately and precisely measure analytes in serum samples.
Crucially, this is not a study about an AI/ML powered medical device. Therefore, many of the typical acceptance criteria and study aspects requested in your prompt regarding AI/ML (e.g., ground truth established by experts, multi-reader multi-case studies, human-in-the-loop performance, training/test set sample sizes for AI, adjudication methods) are not applicable to this type of device and submission.
The "study" described here is a series of analytical performance tests (linearity, precision, method comparison, detection limits, interference) to demonstrate that the new device (ACE Alera system with these reagents) performs comparably to the predicate device (ACE Clinical Chemistry System with the same reagents) and meets established analytical performance specifications for clinical chemistry assays.
Here's a breakdown of the relevant information from the document in the format you requested, with an explanation of why certain AI/ML-centric points are not applicable:
Device: ACE Direct Total Iron-Binding Capacity (TIBC) Reagent, ACE Total Iron Reagent, ACE LDH-L Reagent (for use on ACE Alera Clinical Chemistry System)
1. Table of acceptance criteria and reported device performance:
Since the document does not explicitly present "acceptance criteria" alongside "reported performance" in a single table, I will infer the acceptance criteria from the context of method comparison, linearity, and precision studies, which are standard for IVD device validation, often aiming for performance comparable to predicate devices or within clinically acceptable limits. The reported performance is directly extracted from the tables provided.
Interference:
The acceptance criterion for interference studies in IVD assays is typically that the interferent, up to a specified concentration, does not cause a "significant interference" (e.g., a bias exceeding a defined clinical or analytical threshold). The document lists the concentrations at which no significant interference was observed.
| Interferent | No Significant Interference at or below (Acceptance Criteria Implicit) | Reported Device Performance (Concentration where no significant interference was observed) |
|---|---|---|
| TIBC | ||
| Icterus | Assumes standard limits for non-interference | 59 mg/dL |
| Hemolysis | Assumes standard limits for non-interference | 188 mg/dL* |
| Lipemia | Assumes standard limits for non-interference | 1000 mg/dL |
| Ascorbic Acid | Assumes standard limits for non-interference | 3 mg/dL |
| Iron | ||
| Icterus | Assumes standard limits for non-interference | 59 mg/dL |
| Hemolysis | Assumes standard limits for non-interference | 125 mg/dL* |
| Lipemia | Assumes standard limits for non-interference | 125 mg/dL |
| Ascorbic Acid | Assumes standard limits for non-interference | 6 mg/dL |
| LDH-L | ||
| Icterus | Assumes standard limits for non-interference | 50 mg/dL |
| Hemolysis | Assumes standard limits for non-interference | <31 mg/dL* |
| Lipemia | Assumes standard limits for non-interference | 1000 mg/dL |
| Ascorbic Acid | Assumes standard limits for non-interference | 6 mg/dL |
Note: The asterisk on hemolysis results typically implies a specific consideration or limitation, which would be detailed in the full study report but is not fully elaborated here.
Linearity:
The acceptance criterion for linearity is typically a correlation coefficient (r²) very close to 1 and a slope close to 1 with an intercept close to 0, indicating a proportional relationship between the measured value and the true concentration across the claimed measuring range.
| Reagent | Low Level Tested | High Level Tested | Claimed Linear to (Acceptance Criteria) | Reported Linear Regression Equation | Reported r² |
|---|---|---|---|---|---|
| TIBC | 34 µg/dL | 740 µg/dL | 700 µg/dL | y = 1.020x + 3.1 | 0.9981 |
| Iron | 6 µg/dL | 666 µg/dL | 600 µg/dL | y = 1.030x + 1.9 | 0.9986 |
| LDH-L | 8 U/L | 895 U/L | 850 U/L | y = 1.050x - 0.7 | 0.9981 |
Precision (In-House):
Acceptance criteria for precision are typically defined by maximum allowable standard deviation (SD) or coefficient of variation (%CV) at different concentration levels. These are usually set based on clinical utility or comparison to commercially available assays or predicate devices. The reported values are directly shown.
| Reagent | Sample Level | Mean | Reported Within-Run Precision (SD, %CV) | Reported Total Precision (SD, %CV) |
|---|---|---|---|---|
| TIBC (µg/dL) | Low | 217 | 4.1, 1.9% | 6.7, 3.1% |
| Mid | 270 | 3.7, 1.4% | 7.1, 2.6% | |
| High | 310 | 5.0, 1.6% | 8.6, 2.8% | |
| Iron (µg/dL) | Low | 62 | 3.2, 5.2% | 4.6, 7.3% |
| Mid | 145 | 2.2, 1.5% | 4.2, 2.9% | |
| High | 226 | 4.1, 1.8% | 5.0, 2.2% | |
| LDH-L (U/L) | 1 | 77 | 3.8, 4.9% | 4.2, 5.5% |
| 2 | 119 | 5.1, 4.3% | 5.2, 4.3% | |
| 3 | 270 | 4.5, 1.7% | 5.8, 2.1% | |
| 4 | 651 | 12.6, 1.9% | 13.5, 2.1% |
Method Comparison (In-House ACE (x) vs. In-House ACE Alera (y)):
The acceptance criteria are typically a slope close to 1, an intercept close to 0, and a high correlation coefficient (e.g., >0.99), ideally with the confidence intervals for slope encompassing 1 and for intercept encompassing 0. This indicates analytical equivalence between the two systems.
| Reagent | n (samples) | Range (of samples tested) | Reported Slope | Reported Intercept | Reported Correlation Coefficient | CI Slope | CI Intercept |
|---|---|---|---|---|---|---|---|
| TIBC | 50 | 59 to 676 µg/dL | 0.987 | 3.6 | 0.9960 | 0.962 to 1.013 | -7.2 to 14.4 |
| Iron | 48 | 13 to 549 µg/dL | 0.993 | 0.9 | 0.9995 | 0.984 to 1.003 | -0.6 to 2.3 |
| LDH-L | 58 | 20 to 799 U/L | 0.997 | -3.6 | 0.9991 | 0.985 to 1.008 | -6.1 to -1.1 |
Precision (POL - Point of Care/Physician Office Lab):
Similar to in-house precision, specific %CV or SD limits would be the acceptance criteria. The data shows results from 3 POLs compared to in-house.
| Reagent | Lab | Sample Level | Mean | Within-Run SD, %CV | Total SD, %CV |
|---|---|---|---|---|---|
| Direct TIBC | In-House | 1 | 330 | 5.1, 1.5% | 5.8, 1.8% |
| POL 1 | 1 | 284 | 8.3, 2.9% | 9.6, 3.4% | |
| POL 2 | 1 | 259 | 5.6, 2.2% | 8.5, 3.3% | |
| POL 3 | 1 | 276 | 9.1, 3.3% | 16.7, 6.0% | |
| In-House | 2 | 450 | 4.9, 1.1% | 6.8, 1.5% | |
| POL 1 | 2 | 464 | 6.3, 1.4% | 6.6, 1.4% | |
| POL 2 | 2 | 444 | 4.2, 1.0% | 5.4, 1.2% | |
| POL 3 | 2 | 453 | 3.2, 0.7% | 15.5, 3.4% | |
| In-House | 3 | 530 | 9.4, 1.8% | 10.8, 2.0% | |
| POL 1 | 3 | 544 | 8.2, 1.5% | 8.3, 1.5% | |
| POL 2 | 3 | 520 | 5.0, 1.0% | 9.0, 1.7% | |
| POL 3 | 3 | 533 | 12.6, 2.4% | 20.2, 3.8% | |
| Total Iron | In-House | 1 | 119 | 1.8, 1.5% | 2.5, 2.1% |
| POL 1 | 1 | 119 | 2.7, 2.3% | 3.2, 2.7% | |
| POL 2 | 1 | 122 | 3.1, 2.6% | 3.1, 2.6% | |
| POL 3 | 1 | 116 | 3.2, 2.8% | 3.4, 3.0% | |
| In-House | 2 | 222 | 3.8, 1.7% | 5.1, 2.3% | |
| POL 1 | 2 | 229 | 2.0, 0.9% | 2.5, 1.1% | |
| POL 2 | 2 | 235 | 2.3, 1.0% | 2.4, 1.0% | |
| POL 3 | 2 | 229 | 3.4, 1.5% | 3.9, 1.7% | |
| In-House | 3 | 412 | 5.2, 1.3% | 5.7, 1.4% | |
| POL 1 | 3 | 424 | 4.0, 0.9% | 4.6, 1.1% | |
| POL 2 | 3 | 435 | 2.4, 0.5% | 5.3, 1.2% | |
| POL 3 | 3 | 428 | 11.1, 2.6% | 11.1, 2.6% | |
| LDH-L | In-House | 1 | 118 | 2.9, 2.4% | 5.7, 4.8% |
| POL 1 | 1 | 116 | 1.7, 1.5% | 4.9, 4.3% | |
| POL 2 | 1 | 118 | 3.0, 2.5% | 5.1, 4.3% | |
| POL 3 | 1 | 124 | 3.4, 2.7% | 4.7, 3.8% | |
| In-House | 2 | 433 | 4.7, 1.1% | 6.5, 1.5% | |
| POL 1 | 2 | 437 | 2.9, 0.7% | 5.8, 1.3% | |
| POL 2 | 2 | 449 | 3.7, 0.8% | 5.2, 1.2% | |
| POL 3 | 2 | 446 | 5.8, 1.3% | 6.6, 1.5% | |
| In-House | 3 | 699 | 5.3, 0.8% | 8.5, 1.2% | |
| POL 1 | 3 | 698 | 8.6, 1.2% | 11.5, 1.6% | |
| POL 2 | 3 | 726 | 5.4, 0.8% | 10.0, 1.4% | |
| POL 3 | 3 | 716 | 14.3, 2.0% | 16.9, 2.4% |
Method Comparison (POLs vs. In-House (ACE Alera (x) vs. POL ACE Alera (y))):
Similar to the in-house method comparison, the acceptance criteria are for slopes to be near 1, intercepts near 0, and high correlation coefficients (e.g., >0.99), indicating consistent performance across different lab environments.
| Reagent | Lab Comparison | n (samples) | Range | Reported Regression | Reported Correlation | CI Slope | CI Intercept |
|---|---|---|---|---|---|---|---|
| TIBC | In-House vs. POL 1 | 50 | 59 to 676 | y = 0.994x + 12.4 | 0.9934 | 0.961 to 1.027 | -1.7 to 26.5 |
| In-House vs. POL 2 | 50 | 59 to 676 | y = 0.973x + 0.1 | 0.9954 | 0.946 to 1.001 | -11.4 to 11.6 | |
| In-House vs. POL 3 | 50 | 59 to 676 | y = 1.005x + 9.0 | 0.9898 | 0.963 to 1.047 | -8.7 to 26.6 | |
| Iron | In-House vs. POL 1 | 48 | 13 to 549 | y = 0.976x + 1.0 | 0.9986 | 0.960 to 0.991 | -1.4 to 3.3 |
| In-House vs. POL 2 | 48 | 13 to 549 | y = 0.976x + 2.3 | 0.9981 | 0.959 to 0.994 | -0.4 to 5.0 | |
| In-House vs. POL 3 | 48 | 13 to 549 | y = 0.951x + 0.8 | 0.9966 | 0.927 to 0.974 | -2.7 to 4.4 | |
| LDH-L | In-House vs. POL 1 | 51 | 74 to 799 | y = 0.992x + 3.5 | 0.9986 | 0.977 to 1.008 | -0.1 to 7.1 |
| In-House vs. POL 2 | 51 | 74 to 799 | y = 1.027x + 3.4 | 0.9989 | 1.013 to 1.041 | 0.2 to 6.7 | |
| In-House vs. POL 3 | 51 | 74 to 799 | y = 1.010x + 2.5 | 0.9984 | 0.994 to 1.026 | -1.3 to 6.2 |
2. Sample sizes used for the test set and the data provenance:
-
Sample Sizes for analytical performance studies (Test Set):
- Method Comparison:
- TIBC: 50 samples
- Iron: 48 samples
- LDH-L: 58 (in-house comparison) / 51 (POL comparison) samples
- Linearity: The number of samples/levels for linearity is not explicitly stated as 'n', but standard practice involves multiple levels (typically 5-7) prepared from diluted/spiked samples.
- Precision: Standard runs (e.g., 2 runs per day for 20 days for total precision, with replicates per run for within-run precision) would involve a substantial number of measurements (e.g., 20 days x 2 runs/day x 2 replicates/run = 80 measurements per level). The POL precision data shows n=20, likely referring to 20 days of testing.
- Interference: The number of samples used for interference studies is not explicitly stated.
- Method Comparison:
-
Data Provenance: "In-House" and "POL" (Physician Office Laboratories). The specific country of origin is not explicitly stated, but given the company's location (New Jersey, USA) and FDA 510(k) submission, it's highly likely to be United States. The studies are prospective analytical validation studies, meaning the data was collected specifically to demonstrate the performance of the device.
3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:
Not applicable. This is an in vitro diagnostic (IVD) chemistry analyzer and reagent system. "Ground truth" for IVD analytical performance is established by reference methods, certified reference materials, or highly accurate comparative methods, not by human expert consensus or radiologists. The performance is assessed against quantitative values, not qualitative interpretations requiring expert review.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation (e.g., imaging studies where radiologists disagree). For analytical performance of a chemistry analyzer, the "ground truth" is typically the quantitative value obtained from a reference method or the predicate device, and differences are assessed statistically (e.g., bias, correlation).
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. MRMC studies are specific to evaluating the impact of a device on human readers' performance, typically in diagnostic imaging with AI assistance. This device is an automated chemistry analyzer, not an AI-assisted diagnostic imaging tool. There are no human "readers" in the context of this device's operation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, in essence. The performance data provided (linearity, precision, detection limits, interference, method comparison) represents the "standalone" analytical performance of the automated chemistry system (ACE Alera with the new reagents) in measuring the target analytes in patient samples. There isn't an "algorithm only" in the AI sense, but the chemical reactions and photometric measurements are entirely automated by the device. The data shown is the raw analytical output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for these analytical studies is primarily:
- Highly characterized samples: For linearity, samples with known, precise concentrations (often prepared by dilution of high-concentration materials or spiking low-concentration materials).
- Comparative method/Predicate device: For method comparison, the results generated by the predicate device (ACE Clinical Chemistry System) are treated as the reference or comparative method against which the new ACE Alera system's results are compared. This is a common and accepted "ground truth" for chemical analyzers seeking substantial equivalence.
- Reference materials/controls: For precision and detection limits, control materials with established target values are used.
8. The sample size for the training set:
Not applicable. This is a traditional IVD device (chemical reagents and analyzer), not an AI/ML device that requires a "training set" in the context of machine learning model development. The reagents perform chemical reactions, and the analyzer reads photometric changes; it does not "learn" from data.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set in the AI/ML sense for this device.
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510(k) Summary
| 510(k) Owner: | Alfa Wassermann Diagnostic Technologies, LLC4 Henderson DriveWest Caldwell, NJ 07006 | |||
|---|---|---|---|---|
| Contact: | HKatz@AlfaWassermannUS.comHyman Katz, Ph.D.Phone: 973-852-0158Fax: 973-852-0237 | OCT 0 2 2013 | ||
| Date Summary Prepared: | September 26, 2013 | |||
| Device: | Trade Name: | ACE Direct Total Iron-Binding Capacity (TIBC)Reagent | ||
| Classification: | Class 1 | |||
| Common/Classification Name: | Direct Total Iron-Binding Capacity (TIBC)(21 C.F.R. § 862.1415)Product Code JMO | |||
| Trade Name: | ACE Total Iron Reagent | |||
| Classification: | Class 1 | |||
| Common/Classification Name: | Photometric Method, Iron (Non-Heme)(21 C.F.R. § 862.1410)Product Code JIY | |||
| Trade Name: | ACE LDH-L Reagent | |||
| Classification: | Class 2 | |||
| Common/Classification Name: | NAD Reduction/NADH Oxidation, LactateDehydrogenase(21 C. F.R. § 862.1440)Product Code CFJ |
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| PredicateDevices: | Manufacturer for reagent system predicates:Alfa Wassermann ACE Clinical Chemistry System and ACE Reagents (K930104,K944911, K931786) | Intended Use: | Indications for Use: |
|---|---|---|---|
| DeviceDescriptions: | In the ACE Direct Total Iron-Binding Capacity (TIBC) Reagent assay, Direct TIBCColor Reagent, an acidic buffer containing an iron-binding dye and ferric chloride, isadded to the serum sample. The low pH of Direct TIBC Color Reagent releases iron fromtransferrin. The iron then forms a colored complex with the dye. The colored complex atthe end of the first step represents both the serum iron and excess iron already present inDirect TIBC Color Reagent. Direct TIBC Buffer, a neutral buffer, is then added, shiftingthe pH and resulting in a large increase in the affinity of transferrin for iron. The serumtransferrin rapidly binds the iron by abstracting it from the dye-iron complex. Theobserved decrease in absorbance of the colored dye-iron complex is directly proportionalto the total iron-binding capacity of the serum sample. The absorbance is measured at647 nm. | The ACE Direct Total Iron-Binding (TIBC) Reagent is intended for the quantitativedetermination of total iron-binding capacity in serum using the ACE Alera ClinicalChemistry System. Iron-binding capacity measurements are used in the diagnosis andtreatment of anemia. This test is intended for use in clinical laboratories and physicianoffice laboratories. For in vitro diagnostic use only. | |
| In the ACE Total Iron Reagent assay, transferrin-bound iron in serum is released at anacidic pH and reduced from ferric to ferrous ions. These ions react with ferrozine to forma violet colored complex, which is measured bichromatically at 554 nm/692 nm. Theintensity of color produced is directly proportional to the serum iron concentration. | The ACE Total Iron Reagent is intended for the quantitative determination of iron inserum using the ACE Alera Clinical Chemistry System. Iron (non-heme) measurementsare used in the diagnosis and treatment of diseases such as iron deficiency anemia,hemochromatosis (a disease associated with widespread deposit in the tissues of twoiron-containing pigments, hemosiderin and hemofuscin, and characterized bypigmentation of the skin), and chronic renal disease. This test is intended for use inclinical laboratories and physician office laboratories. For in vitro diagnostic use only. | ||
| In the ACE LDH-L Reagent assay, lactate dehydrogenase catalyzes the conversion of L-lactate to pyruvate. Nicotinamide adenine dinucleotide (NAD+) acts as an acceptor forthe hydrogen ions released from the L-lactate and is converted to reduced nicotinamideadenine dinucleotide (NADH). NADH absorbs strongly at 340 nm whereas NAD+ doesnot. Therefore, the rate of conversion of NAD+ to NADH can be determined bymonitoring the increase in absorbance bichromatically at 340 nm/647 nm. This rate ofconversion from NAD+ to NADH is directly proportional to the lactate dehydrogenaseactivity in the sample. | The ACE LDH-L Reagent is intended for the quantitative determination of lactatedehydrogenase activity in serum using the ACE Alera Clinical Chemistry System.Lactate dehydrogenase measurements are used in the diagnosis and treatment of liverdiseases such as acute viral hepatitis, cirrhosis, and metastatic carcinoma of the liver,cardiac diseases such as myocardial infarction and tumors of the lung or kidneys. Thistest is intended for use in clinical laboratories and physician office laboratories. For invitro diagnostic use only. | ||
| TechnologicalCharacteristics: | The ACE Direct Total Iron-Binding Capacity (TIBC) Reagent is composed of tworeagent bottles (Direct TIBC Color Reagent and Direct TIBC Buffer). The Direct TIBCColor Reagent (R1) contains: Chromazurol B, Cetrimide, ferric chloride andacetate buffer. The Direct TIBC Buffer (R2) contains: sodium bicarbonate buffer. | ||
| The ACE Total Iron Reagent is composed of two reagent bottles (Buffer and ColorReagent). The Buffer (R1) contains: hydroxylamine hydrochloride,acetate buffer (pH 4.5) and surfactant. The Color Reagent (R2) contains: ferrozine andhydroxylamine hydrochloride. | |||
| The ACE LDH-L Reagent is composed of two reagent bottles (Substrate and CoenzymeReagent). The reagents contain L-lactic acid and nicotinamide adenine dinucleotide. |
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Device Comparison with Predicate
Comparison of similarities and differences with predicate device
ACE Direct Total Iron-Binding Capacity (TIBC) Reagent
| ACE Direct TIBC Reagent | Candidate Device | Predicate Device K930104 (ACE Direct TIBC Reagent) | |
|---|---|---|---|
| Intended Use/ Indications for Use | The ACE Direct Total Iron-Binding Capacity (TIBC) Reagent is intended for the quantitative determination of total iron-binding capacity in serum using the ACE Alera Clinical Chemistry System. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia. This test is intended for use in clinical laboratories and physician office laboratories. For in vitro diagnostic use only. | The ACE Direct Total Iron-Binding Capacity (TIBC) Reagent is intended for the quantitative determination of total iron-binding capacity in serum using the ACE Clinical Chemistry System. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia. This test is intended for use in clinical laboratories. For in vitro diagnostic use only. | |
| Method | Photometric | Same | |
| Calibration Stability | 30 days | Same | |
| On Board Stability | 30 days | Same | |
| Sample Type | Serum | Same | |
| Sample Volume | 16 μL | Same | |
| Reaction Volume | 291 μL | Same | |
| Expected values | 250-425 μg/dL | 250-450 μg/dL | |
| Measuring range | 52-700 μg/dL | From the lowest calibrator concentration to 700 μg/dL | |
| Sample Stability | Separated from cells, serum TIBC is stable for 4 days at 18-26°C and 1 week at 2-8°C. | Same |
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| ACE Total IronReagent | Candidate Device | Predicate DeviceK944911: (ACE Total Iron Reagent) |
|---|---|---|
| IntendedUse/Indications forUse | The ACE Total Iron Reagent is intendedfor the quantitative determination of ironin serum using the ACE Alera ClinicalChemistry System. Iron (non-heme)measurements are used in the diagnosisand treatment of diseases such as irondeficiency anemia, hemochromatosis (adisease associated with widespreaddeposit in the tissues of two iron-containing pigments, hemosiderin andhemofuscin, and characterized bypigmentation of the skin), and chronicrenal disease. This test is intended for usein clinical laboratories and physicianoffice laboratories. For in vitrodiagnostic use only. | The ACE Total Iron Reagentis intended for thequantitative determination ofiron in serum using the ACEClinical Chemistry System.Iron (non-heme)measurements are used in thediagnosis and treatment ofdiseases such as irondeficiency anemia,hemochromatosis (a diseaseassociated with widespreaddeposit in the tissues of twoiron-containing pigments,hemosiderin and hemofuscinand characterized bypigmentation of the skin),and chronic renal disease.This test is intended for usein clinical laboratories. Forin vitro diagnostic use only. |
| Method | Photometric | Same |
| Calibration Stability | 30 days | Same |
| On Board Stability | 30 days | Same |
| Sample Type | Serum | Same |
| Sample Volume | 50 µL | Same |
| Reaction Volume | 335 µL | Same |
| Expected values | Male: 65-175 µg/dLFemale: 50-170 µg/dL | Same |
| Measuring range | 9.15-600 µg/dL | 2-600 µg/dL |
| Sample Stability | Separated from cells, serum iron is stablefor 7 days at room temperature (20-25°C) | Separated from cells, serumiron is stable for 4 days atroom temperature (15-30°C) |
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| ACE LDH-L Reagent | ||
|---|---|---|
| ACE LDH-L Reagent | Candidate Device | Predicate DeviceK931786(ACE LDH-L Reagent) |
| IntendedUse/Indicationsfor Use | The ACE LDH-L Reagent isintended for the quantitativedetermination of lactatedehydrogenase activity in serumusing the ACE Alera ClinicalChemistry System. Lactatedehydrogenase measurements areused in the diagnosis andtreatment of liver diseases such asacute viral hepatitis, cirrhosis, andmetastatic carcinoma of the liver,cardiac diseases such asmyocardial infarction and tumorsof the lung or kidneys. This test isintended for use in clinicallaboratories and physicianoffice laboratories. For in vitrodiagnostic use only. | The ACE LDH-L Reagent isintended for the quantitativedetermination of lactatedehydrogenase activity inserum using the ACE ClinicalChemistry System. Lactatedehydrogenase measurementsare used in the diagnosis andtreatment of liver diseases suchas acute viral hepatitis,cirrhosis, and metastaticcarcinoma of the liver, cardiacdiseases such as myocardialinfarction and tumors of thelung or kidneys. This test isintended for use in clinicallaboratories. For in vitrodiagnostic use only. |
| Method | Photometric | Same |
| Calibration Stability | Not a calibrated test | Same |
| On Board Stability | 30 days | Same |
| Sample Type | Serum | Same |
| Sample Volume | 5 µL | Same |
| Reaction Volume | 170 µL | Same |
| Expected values | 100-190 U/L | Same |
| Measuring range | 18-850 U/L | 17-850 U/L |
| Sample Stability | Separated from cells, LDH activityis stable for 7 days at 20-25°C, 4days at 4-8°C and 6 weeks at -20°C.Loss of activity after freezing hasalso been noted | Separated from cells, LDHactivity is stable for 3 days atboth 2-8°C and roomtemperature. Loss of activityafter freezing has also beennoted. |
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Reportable Range
Performance data for the Alfa Wassermann ACE Reagents on the Alfa Wassermann ACE Alera Clinical Chemistry System
Detection Limits - ACE Alera Clinical Chemistry System
| TIBC | Iron | LDH-L | |
|---|---|---|---|
| LoB | 11 µg/dL | 0 µg/dL | 11 U/L |
| LoD | 24 µg/dL | 1 µg/dL | 18 U/L |
| LoQ | 52 µg/dL | 9.15 µg/dL | 18 U/L |
Linearity - ACE Alera Clinical Chemistry System
| Reagent | Low LevelTested | High LevelTested | Linear to: | Linear Regressionequation |
|---|---|---|---|---|
| TIBC | 34 µg/dL | 740 µg/dL | 700 µg/dL | $y = 1.020x + 3.1$ $r² = 0.9981$ |
| Iron | 6 µg/dL | 666 µg/dL | 600 µg/dL | $y = 1.030x + 1.9$ $r² = 0.9986$ |
| LDH-L | 8 U/L | 895 U/L | 850 U/L | $y = 1.050x - 0.7$ $r² = 0.9981$ |
{7}------------------------------------------------
| Interferent | No Significant Interference at or below: | TIBC | Iron | LDH-L |
|---|---|---|---|---|
| Icterus | 59 mg/dL | 59 mg/dL | 50 mg/dL | |
| Hemolysis | 188 mg/dL* | 125 mg/dL* | <31 mg/dL* | |
| Lipemia | 1000 mg/dL | 125 mg/dL | 1000 mg/dL | |
| Ascorbic Acid | 3 mg/dL | 6 mg/dL | 6 mg/dL |
{8}------------------------------------------------
| PerformanceData: | Precision - ACE Alera Clinical Chemistry System | ||||
|---|---|---|---|---|---|
| Precision -In-House | Precision (SD, %CV) | ||||
| ACE Alera | Mean | Within-Run | Total | ||
| TIBCµg/dL | Low | 217 | 4.1, 1.9% | 6.7, 3.1% | |
| Mid | 270 | 3.7, 1.4% | 7.1, 2.6% | ||
| High | 310 | 5.0, 1.6% | 8.6, 2.8% | ||
| Ironµg/dL | Low | 62 | 3.2, 5.2% | 4.6, 7.3% | |
| Mid | 145 | 2.2, 1.5% | 4.2, 2.9% | ||
| High | 226 | 4.1, 1.8% | 5.0, 2.2% | ||
| LDH-U/L | 1 | 77 | 3.8, 4.9% | 4.2, 5.5% | |
| 2 | 119 | 5.1, 4.3% | 5.2, 4.3% | ||
| 3 | 270 | 4.5, 1.7% | 5.8, 2.1% | ||
| 4 | 651 | 12.6, 1.9% | 13.5, 2.1% |
{9}------------------------------------------------
Method
.
Comparison -In-House
Method Comparison - ACE Alera Clinical Chemistry System
In-House ACE (x) vs. In-House ACE Alera (y)
| TIBC | Iron | LDH-L | |
|---|---|---|---|
| n | 50 | 48 | 58 |
| Range | 59 to 676 µg/dL | 13 to 549 µg/dL | 20 to 799 U/L |
| Slope | 0.987 | 0.993 | 0.997 |
| Intercept | 3.6 | 0.9 | -3.6 |
| CorrelationCoefficient | 0.9960 | 0.9995 | 0.9991 |
| Std. Error | 9.2 | 3.6 | 6.8 |
| CI Slope | 0.962 to 1.013 | 0.984 to 1.003 | 0.985 to 1.008 |
| CI Intercept | -7.2 to 14.4 | -0.6 to 2.3 | -6.1 to -1.1 |
{10}------------------------------------------------
POL - Precision for ACE and ACE Alera Clinical Chemistry Systems
Precision -
POL
| Direct TIBC"n=20 | ACE Resultµg/dL SD, %CV | ACE Alera Resultµg/dL SD, %CV | |||||
|---|---|---|---|---|---|---|---|
| Lab | Sample | Mean | Within-Run | Total | Mean | Within-Run | Total |
| In-House | 1 | 336 | 2.90.9% | 5.51.6% | 330 | 5.11.5% | 5.81.8% |
| POL 1 | 1 | 290 | 10.83.7% | 15.65.4% | 284 | 8.32.9% | 9.63.4% |
| POL 2 | 1 | 275 | 3.51.3% | 11.44.1% | 259 | 5.62.2% | 8.53.3% |
| POL 3 | 1 | 295 | 5.41.8% | 5.51.9% | 276 | 9.13.3% | 16.76.0% |
| In-House | 2 | 455 | 5.01.1% | 8.11.8% | 450 | 4.91.1% | 6.81.5% |
| POL 1 | 2 | 452 | 10.22.3% | 10.42.3% | 464 | 6.31.4% | 6.61.4% |
| POL 2 | 2 | 442 | 5.91.3% | 12.52.8% | 444 | 4.21.0% | 5.41.2% |
| POL 3 | 2 | 465 | 4.71.0% | 5.31.1% | 453 | 3.20.7% | 15.53.4% |
| In-House | 3 | 539 | 9.81.8% | 12.82.4% | 530 | 9.41.8% | 10.82.0% |
| POL 1 | 3 | 531 | 17.13.2% | 20.43.8% | 544 | 8.21.5% | 8.31.5% |
| POL 2 | 3 | 530 | 7.41.4% | 14.12.7% | 520 | 5.01.0% | 9.01.7% |
| POL 3 | 3 | 551 | 4.60.8% | 5.91.1% | 533 | 12.62.4% | 20.23.8% |
Page 11 of 15
{11}------------------------------------------------
POL - Precision for ACE and ACE Alera Clinical Chemistry Systems
Precision -POL
| Total Ironn=20 | ACE Resultµg/dL SD, %CV | ACE Alera Resultµg/dL SD, %CV | |||||
|---|---|---|---|---|---|---|---|
| Lab | Sample | Mean | Within-Run | Total | Mean | Within-Run | Total |
| In-House | 1 | 117 | 1.41.2% | 2.62.2% | 119 | 1.81.5% | 2.52.1% |
| POL 1 | 1 | 120 | 6.45.4% | 6.95.8% | 119 | 2.72.3% | 3.22.7% |
| POL 2 | 1 | 120 | 6.35.3% | 6.65.5% | 122 | 3.12.6% | 3.12.6% |
| POL 3 | 1 | 121 | 4.43.7% | 4.43.7% | 116 | 3.22.8% | 3.43.0% |
| In-House | 2 | 223 | 2.91.3% | 5.62.5% | 222 | 3.81.7% | 5.12.3% |
| POL 1 | 2 | 227 | 3.41.5% | 3.91.7% | 229 | 2.00.9% | 2.51.1% |
| POL 2 | 2 | 227 | 2.61.1% | 5.12.2% | 235 | 2.31.0% | 2.41.0% |
| POL 3 | 2 | 225 | 1.30.6% | 1.90.8% | 229 | 3.41.5% | 3.91.7% |
| In-House | 3 | 416 | 8.72.1% | 9.12.2% | 412 | 5.21.3% | 5.71.4% |
| POL 1 | 3 | 420 | 5.01.2% | 5.61.3% | 424 | 4.00.9% | 4.61.1% |
| POL 2 | 3 | 423 | 6.61.6% | 9.32.2% | 435 | 2.40.5% | 5.31.2% |
| POL 3 | 3 | 422 | 5.61.3% | 6.01.4% | 428 | 11.12.6% | 11.12.6% |
Page 12 of 15
1
{12}------------------------------------------------
Performance
POL - Precision for ACE and ACE Alera Clinical Chemistry Systems
Data: Precision -
POL
| LDH-Ln=20 | ACE ResultU/L SD, %CV | ACE Alera ResultU/L SD, %CV | |||||
|---|---|---|---|---|---|---|---|
| Lab | Sample | Mean | Within-Run | Total | Mean | Within-Run | Total |
| In-House | 1 | 121 | 2.82.3% | 4.33.6% | 118 | 2.92.4% | 5.74.8% |
| POL 1 | 1 | 113 | 2.11.9% | 5.44.8% | 116 | 1.71.5% | 4.94.3% |
| POL 2 | 1 | 114 | 2.52.2% | 6.45.6% | 118 | 3.02.5% | 5.14.3% |
| POL 3 | 1 | 117 | 2.11.8% | 2.72.3% | 124 | 3.42.7% | 4.73.8% |
| In-House | 2 | 446 | 5.81.3% | 6.91.5% | 433 | 4.71.1% | 6.51.5% |
| POL 1 | 2 | 433 | 5.81.3% | 8.11.9% | 437 | 2.90.7% | 5.81.3% |
| POL 2 | 2 | 433 | 4.81.1% | 5.71.3% | 449 | 3.70.8% | 5.21.2% |
| POL 3 | 2 | 437 | 4.51.0% | 5.21.2% | 446 | 5.81.3% | 6.61.5% |
| In-House | 3 | 715 | 10.11.4% | 11.91.7% | 699 | 5.30.8% | 8.51.2% |
| POL 1 | 3 | 699 | 10.01.4% | 18.02.6% | 698 | 8.61.2% | 11.51.6% |
| POL 2 | 3 | 698 | 12.71.8% | 12.71.8% | 726 | 5.40.8% | 10.01.4% |
| POL 3 | 3 | 697 | 7.61.1% | 8.81.3% | 716 | 14.32.0% | 16.92.4% |
Page 13 of 15
{13}------------------------------------------------
| PerformanceData: | POL - Method Comparison for ACE Clinical Chemistry System | ||||
|---|---|---|---|---|---|
| MethodComparison -POL on ACE | Reagent | Statistic | In-House (x) vs.ACE POL 1 (y) | In-House (x) vs.ACE POL 2 (y) | In-House (x) vs.ACE POL 3 (y) |
| TIBC | n | 50 | 50 | 50 | |
| Range | 59 to 676 | 59 to 676 | 59 to 676 | ||
| Regression | $y = 0.979x + 4.3$ | $y = 0.974x + 8.7$ | $y = 1.006x - 1.4$ | ||
| Correlation | 0.9972 | 0.9966 | 0.9966 | ||
| Std. Error Est. | 7.7 | 8.4 | 8.7 | ||
| CI Slope | 0.958 to 1.000 | 0.951 to 0.998 | 0.982 to 1.030 | ||
| CI Intercept | -4.8 to 13.3 | -1.2 to 18.5 | -11.6 to 8.8 | ||
| Iron | n | 48 | 48 | 48 | |
| Range | 13 to 549 | 13 to 549 | 13 to 549 | ||
| Regression | $y=0.977x - 1.3$ | $y = 0.992x - 0.8$ | $y = 0.992x + 0.9$ | ||
| Correlation | 0.9990 | 0.9994 | 0.9994 | ||
| Std. Error Est. | 5.0 | 3.8 | 3.8 | ||
| CI Slope | 0.964 to 0.990 | 0.982 to 1.003 | 0.982 to 1.002 | ||
| CI Intercept | -3.3 to 0.6 | -2.3 to 0.7 | -0.6 to 2.4 | ||
| LDH-L | n | 51 | 51 | 51 | |
| Range | 74 to 799 | 74 to 799 | 74 to 799 | ||
| Regression | $y = 0.996x + 1.3$ | $y=1.010x - 5.3$ | $y = 0.978x + 7.2$ | ||
| Correlation | 0.9979 | 0.9989 | 0.9989 | ||
| Std. Error Est. | 10.6 | 7.7 | 7.6 | ||
| CI Slope | 0.978 to 1.014 | 0.996 to 1.023 | 0.964 to 0.991 | ||
| CI Intercept | -3.0 to 5.6 | -8.5 to -2.2 | 4.2 to 10.3 |
{14}------------------------------------------------
| PerformanceData: | POL – Method Comparison for ACE Alera Clinical Chemistry System | ||||
|---|---|---|---|---|---|
| MethodComparison -POL on ACEAlera | Reagent | Statistic | In-House (x)vs.ACE AleraPOL 1 (y) | In-House (x)vs.ACE AleraPOL 2 (y) | In-House (x)vs.ACE AleraPOL 3 (y) |
| TIBC | n | 50 | 50 | 50 | |
| Range | 59 to 676 | 59 to 676 | 59 to 676 | ||
| Regression | y = 0.994x + 12.4 | y = 0.973x + 0.1 | y = 1.005x + 9.0 | ||
| Correlation | 0.9934 | 0.9954 | 0.9898 | ||
| Std. Error Est. | 12.0 | 9.8 | 15.1 | ||
| CI Slope | 0.961 to 1.027 | 0.946 to 1.001 | 0.963 to 1.047 | ||
| CI Intercept | -1.7 to 26.5 | -11.4 to 11.6 | -8.7 to 26.6 | ||
| Iron | n | 48 | 48 | 48 | |
| Range | 13 to 549 | 13 to 549 | 13 to 549 | ||
| Regression | y = 0.976x + 1.0 | y = 0.976x + 2.3 | y = 0.951x + 0.8 | ||
| Correlation | 0.9986 | 0.9981 | 0.9966 | ||
| Std. Error Est. | 5.9 | 6.8 | 8.9 | ||
| CI Slope | 0.960 to 0.991 | 0.959 to 0.994 | 0.927 to 0.974 | ||
| CI Intercept | -1.4 to 3.3 | -0.4 to 5.0 | -2.7 to 4.4 | ||
| LDH-L | n | 51 | 51 | 51 | |
| Range | 74 to 799 | 74 to 799 | 74 to 799 | ||
| Regression | y = 0.992x + 3.5 | y = 1.027x + 3.4 | y = .1.010x + 2.5 | ||
| Correlation | 0.9986 | 0.9989 | 0.9984 | ||
| Std. Error Est. | 8.8 | 8.1 | 9.3 | ||
| CI Slope | 0.977 to 1.008 | 1.013 to 1.041 | 0.994 to 1.026 | ||
| CI Intercept | -0.1 to 7.1 | 0.2 to 6.7 | -1.3 to 6.2 | ||
| Conclusions: | Based on the foregoing data, the device is safe and effective for use in clinicallaboratories and physician office laboratories. These data indicate that the ACE AleraClinical Chemistry System is substantially equivalent to the predicate device ACEClinical Chemistry System. |
י .
{15}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/15/Picture/1 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized caduceus, which is a traditional symbol of medicine, with a single staff entwined by two snakes.
Public Ficality Service
Food and Drug Administration 10903 New Hampshire Avenue Document Contro] Center - WO66-G609 Silver Spring, MD 20993-0002
October 2, 2013
Alfa Wassermann Diagnostic Technologies, LLC c/o Hyman Katz, Ph.D. 4 Henderson Drive WEST CALDWELL NJ 07006
Re: K131975
Trade/Device Name: ACE LDH-L Reagent ACE Direct Total Iron-Binding Capacity (TIBC) Reagent ACE Total Iron Reagent Regulation Number: 21 CFR 862,1440 Regulation Name: Lactate dehydrogenase test system Regulatory Class: II, exempt, meets limitations of excmption per 21 CFR 862.9 (c)(9) Product Code: CFJ, JMO, JIY Dated: August 30, 2013
Received: September 4, 2013
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 10 devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{16}------------------------------------------------
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Carol C. Benson -S for
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
{17}------------------------------------------------
Page 1 of 2
Indications for Use
510(k) Number : K131975
Device Name: ACE Direct Total Iron-Binding Capacity (TIBC) Reagent
Indications for Use: The ACE Direct Total Iron-Binding Capacity (TIBC) Reagent is intended for the quantitative determination of total iron-binding capacity in serum using the ACE Alera Clinical Chemistry System. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia. This test is intended for use in clinical laboratories and physician office laboratories. For in vitro diagnostic use only.
Device Name: ACE Total Iron Reagent
Indications for Use: The ACE Total Iron Reagent is intended for the quantitative determination of iron in serum using the ACE Alera Clinical Chemistry System. Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia. hemochromatosis (a disease associated with widespread deposit in the tissues of two iron-containing pigments, hemosiderin and hemofuscin, and characterized by pigmentation of the skin), and chronic renal disease. This test is intended for use in clinical laboratories and physician office laboratories. For in vitro diagnostic use only.
Prescription Use X (21 CFR Part 801 Subpart D)
Over-The-Counter Use. (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of In Vitro Devices or Radiological Health (OIR)
Yung W. Chan -S
Division Sign-Off Office of In Vitro Devices or Radiological Health 510(k) K131975
{18}------------------------------------------------
Indications for Use
510(k) Number : K131975
Device Name: ACE LDH-L Reagent
Indications for Use: The ACE LDH-L Reagent is intended for the quantitative determination of lactate dehydrogenase activity in serum using the ACE Alera Clinical Chemistry System. Lactate dehydrogenase measurements are used in the diagnosis and treatment of liver diseases such as acute viral hepatitis, cirrhosis, and metastatic carcinoma of the liver, cardiac diseases such as myocardial infarction and tumors of the lung or kidneys. This test is intended for use in clinical laboratories and 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)
Yung W. Chan -S
Division Sign-Off Office of In Vitro Devices or Radiological Health 510(k) ki31975
§ 862.1440 Lactate dehydrogenase test system.
(a)
Identification. A lactate dehydrogenase test system is a device intended to measure the activity of the enzyme lactate dehydrogenase in serum. Lactate dehydrogenase measurements are used in the diagnosis and treatment of liver diseases such as acute viral hepatitis, cirrhosis, and metastatic carcinoma of the liver, cardiac diseases such as myocardial infarction, and tumors of the lung or kidneys.(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 § 862.9.