ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, ACE LDH-L REAGENT

• K Number: K131975
• Device Name: ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, ACE LDH-L REAGENT
• Manufacturer: ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC.
• Date Cleared: 2013-10-02 ( 96 days)
• Product Code: CFJ JIY JMO
• Regulation Number: 862.1440

Intended 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 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.

Device Description

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.

Predicate Devices

K930104, K944911, K931786

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description details standard chemical reactions and photometric measurements for quantitative analysis. There is no mention of AI or ML in the intended use, device description, or performance studies.

Therapeutic

No
The device is an in vitro diagnostic reagent used for quantitative determination of substances in serum to aid in diagnosis and treatment monitoring, not to provide therapy.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the measurements (total iron-binding capacity, iron, and lactate dehydrogenase activity) are "used in the diagnosis and treatment of anemia" or "used in the diagnosis and treatment of diseases such as iron deficiency anemia, hemochromatosis," or "used in the diagnosis and treatment of liver diseases... cardiac diseases." This directly indicates its role in diagnosing diseases.

SaMD (Software as a Medical Device)

No

The device description clearly details chemical reagents and their interactions with serum samples, which are physical components used in a laboratory setting. It also mentions a "Clinical Chemistry System" which is a hardware device. This is not a software-only device.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

• Explicit Statement: The intended use section for each reagent explicitly states "For in vitro diagnostic use only."
• Intended Use: The reagents are intended for the quantitative determination of substances (Total Iron-Binding Capacity, Iron, and Lactate Dehydrogenase) in serum, which is a biological sample taken from the human body.
• Purpose: The measurements are used in the diagnosis and treatment of various diseases (anemia, hemochromatosis, chronic renal disease, liver diseases, cardiac diseases, tumors). This aligns with the definition of an IVD, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
• Setting: The intended users are clinical laboratories and physician office laboratories, which are typical settings for IVD testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The ACE Direct Total Iron-Binding (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.

Product codes (comma separated list FDA assigned to the subject device)

JMO, JIY, CFJ

Device Description

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. The ACE Direct Total Iron-Binding Capacity (TIBC) Reagent is composed of two reagent bottles (Direct TIBC Color Reagent and Direct TIBC Buffer). The Direct TIBC Color Reagent (R1) contains: Chromazurol B, Cetrimide, ferric chloride and acetate buffer. The Direct TIBC Buffer (R2) contains: sodium bicarbonate buffer.

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. The ACE Total Iron Reagent is composed of two reagent bottles (Buffer and Color Reagent). The Buffer (R1) contains: hydroxylamine hydrochloride, acetate buffer (pH 4.5) and surfactant. The Color Reagent (R2) contains: ferrozine and hydroxylamine hydrochloride.

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 ACE LDH-L Reagent is composed of two reagent bottles (Substrate and Coenzyme Reagent). The reagents contain L-lactic acid and nicotinamide adenine dinucleotide.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

clinical laboratories and physician office laboratories.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Performance data for the Alfa Wassermann ACE Reagents on the Alfa Wassermann ACE Alera Clinical Chemistry System were provided including Detection Limits, Linearity, and Interferent studies. Precision studies (In-House and POL) and Method Comparisons (In-House and POL) were also provided.

Detection Limits - ACE Alera Clinical Chemistry System:
TIBC: LoB 11 µg/dL, LoD 24 µg/dL, LoQ 52 µg/dL
Iron: LoB 0 µg/dL, LoD 1 µg/dL, LoQ 9.15 µg/dL
LDH-L: LoB 11 U/L, LoD 18 U/L, LoQ 18 U/L

Linearity - ACE Alera Clinical Chemistry System:
TIBC: Low Level Tested 34 µg/dL, High Level Tested 740 µg/dL, Linear to: 700 µg/dL. Linear Regression equation y = 1.020x + 3.1 r² = 0.9981
Iron: Low Level Tested 6 µg/dL, High Level Tested 666 µg/dL, Linear to: 600 µg/dL. Linear Regression equation y = 1.030x + 1.9 r² = 0.9986
LDH-L: Low Level Tested 8 U/L, High Level Tested 895 U/L, Linear to: 850 U/L. Linear Regression equation y = 1.050x - 0.7 r² = 0.9981

Interferent Studies:
No significant interference at or below:
TIBC: Icterus 59 mg/dL, Hemolysis 188 mg/dL*, Lipemia 1000 mg/dL, Ascorbic Acid 3 mg/dL
Iron: Icterus 59 mg/dL, Hemolysis 125 mg/dL*, Lipemia 125 mg/dL, Ascorbic Acid 6 mg/dL
LDH-L: Icterus 50 mg/dL, Hemolysis

Regulation Number and Section

§ 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.

Summary

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K131975

510(k) Summary

| 510(k) Owner: | Alfa Wassermann Diagnostic Technologies, LLC
4 Henderson Drive
West Caldwell, NJ 07006 | | | |
|------------------------|----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|--|--------------|
| | Contact: | [e-mail]
Hyman Katz, Ph.D.
Phone: [phone]
Fax: [phone] | | 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, Lactate
Dehydrogenase
(21 C. F.R. § 862.1440)
Product Code CFJ | | |

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| Predicate
Devices: | Manufacturer for reagent system predicates:
Alfa Wassermann ACE Clinical Chemistry System and ACE Reagents (K930104,
K944911, K931786) | Intended Use: | Indications for Use: |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Descriptions: | 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. | | The ACE Direct Total Iron-Binding (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. |
| | 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. | | 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. |
| | 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 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. |
| Technological
Characteristics: | The ACE Direct Total Iron-Binding Capacity (TIBC) Reagent is composed of two
reagent bottles (Direct TIBC Color Reagent and Direct TIBC Buffer). The Direct TIBC
Color Reagent (R1) contains: Chromazurol B, Cetrimide, ferric chloride and
acetate buffer. The Direct TIBC Buffer (R2) contains: sodium bicarbonate buffer. | | |
| | The ACE Total Iron Reagent is composed of two reagent bottles (Buffer and Color
Reagent). The Buffer (R1) contains: hydroxylamine hydrochloride,
acetate buffer (pH 4.5) and surfactant. The Color Reagent (R2) contains: ferrozine and
hydroxylamine hydrochloride. | | |
| | The ACE LDH-L Reagent is composed of two reagent bottles (Substrate and Coenzyme
Reagent). 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 Iron
Reagent | Candidate Device | Predicate Device
K944911
: (ACE Total Iron Reagent) |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use/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. | The ACE Total Iron Reagent
is intended for the
quantitative determination of
iron in serum using the ACE
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. 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 | 50 µL | Same |
| Reaction Volume | 335 µL | Same |
| Expected values | Male: 65-175 µg/dL
Female: 50-170 µg/dL | Same |
| Measuring range | 9.15-600 µg/dL | 2-600 µg/dL |
| Sample Stability | Separated from cells, serum iron is stable
for 7 days at room temperature (20-25°C) | Separated from cells, serum
iron is stable for 4 days at
room temperature (15-30°C) |

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ACE LDH-L Reagent
ACE LDH-L Reagent	Candidate Device	Predicate Device
K931786
(ACE LDH-L Reagent)
Intended
Use/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.	The ACE LDH-L Reagent is
intended for the quantitative
determination of lactate
dehydrogenase activity in
serum using the ACE 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. For in vitro
diagnostic 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 activity
is stable for 7 days at 20-25°C, 4
days at 4-8°C and 6 weeks at -20°C.
Loss of activity after freezing has
also been noted	Separated from cells, LDH
activity is stable for 3 days at
both 2-8°C and room
temperature. Loss of activity
after freezing has also been
noted.

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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 Level
Tested | High Level
Tested | Linear to: | Linear Regression
equation |
|---------|---------------------|----------------------|------------|----------------------------------|
| 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 | $y = 1.050x - 0.7$ $r² = 0.9981$ |

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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*