DIMENSION IRON FLEX REAGENT CARTRIDGE (IRON-DF85)

K060264 · Dade Behring, Inc. · JIY · Mar 8, 2006 · Clinical Chemistry

Device Facts

• Record ID: K060264
• Device Name: DIMENSION IRON FLEX REAGENT CARTRIDGE (IRON-DF85)
• Applicant: Dade Behring, Inc.
• Product Code: JIY · Clinical Chemistry
• Decision Date: Mar 8, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1410
• Device Class: Class 1

Indications for Use

The IRON method for the Dimension® clinical chemistry system is an in vitro diagnostic test intended to quantitatively measure iron in human serum and plasma. Iron measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia and other disorders of iron metabolism.

Device Story

The Dimension® IRON Flex® reagent cartridge is an in vitro diagnostic device used on the Dade Behring Dimension® clinical chemistry system. It quantitatively measures total iron in human serum and heparinized plasma. The device uses a chromatic assay principle: iron is released from transferrin in acidic conditions, reduced to Fe++ by ascorbic acid, and complexed with Ferene®. The system performs a bi-chromatic endpoint measurement at 600 and 700 nm. The absorbance is directly proportional to the iron concentration. The device is intended for professional use in clinical laboratories. Results assist healthcare providers in diagnosing and monitoring iron-related metabolic disorders. The system provides automated quantification, reducing manual processing requirements.

Clinical Evidence

Bench testing only. Precision/reproducibility evaluated per CLSI EP5-A2 (20 days, duplicate testing). Linearity confirmed (r=0.999) across 5.0–1000 µg/dL range. Analytical sensitivity is 5 µg/dL. Interference testing performed per CLSI EP7-A. Method comparison (n=147) against predicate showed high correlation (r=0.9996, slope 0.980). Matrix comparison (n=129) confirmed equivalence between serum and heparinized plasma.

Technological Characteristics

In vitro diagnostic reagent cartridge. Principle: Bi-chromatic endpoint spectrophotometry (600/700 nm). Reagents: Ferene® chromophore, thiourea, ascorbic acid. Standardization: NIST SRM 937. Connectivity: Integrated with Dimension® clinical chemistry system. Standards: CLSI EP5-A2, EP7-A, ISO 14971, ISO 15223.

Indications for Use

Indicated for quantitative measurement of iron in human serum and plasma to aid in the diagnosis and treatment of iron deficiency anemia and other iron metabolism disorders.

Regulatory Classification

Identification

An iron (non-heme) test system is a device intended to measure iron (non-heme) in serum and plasma. 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.

Predicate Devices

• Dimension® IRN Iron Flex® reagent cartridge (DF49A) (k944093, k010061)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE

A. 510(k) Number:
k060264

B. Purpose for Submission:
Clearance of a new device

C. Measurand:
Total Iron

D. Type of Test:
Quantitative

E. Applicant:
Dade Behring, Inc.

F. Proprietary and Established Names:
Dimension® Iron Flex® reagent cartridge (IRON-DF85)

G. Regulatory Information:
1. Regulation section:
21 CFR § 862.1410
2. Classification:
Class I, reserved
3. Product code:
JIY, Iron (non-heme) test system
4. Panel:
Clinical Chemistry (75)

H. Intended Use:
1. Intended use(s):
The IRON method for the Dimension® clinical chemistry system is an in vitro diagnostic test intended to quantitatively measure iron in human serum and plasma.
2. Indication(s) for use:
The IRON method for the Dimension® clinical chemistry system is an in vitro diagnostic test intended to quantitatively measure iron in human serum and plasma. Iron measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia and other disorders of iron metabolism.
3. Special conditions for use statement(s):
None
4. Special instrument requirements:
Dimension® clinical chemistry system

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I. Device Description:

The Dimension® IRON Flex® reagent cartridge (DF85) is an in vitro diagnostic device that consists of prepackaged reagents in a plastic eight well cartridge for use on the Dade Behring Dimension® clinical chemistry system for the quantitative determination of iron in serum and plasma.

J. Substantial Equivalence Information:

1. Predicate device name(s):
Dimension® IRN Iron Flex® reagent cartridge (DF49A)

2. Predicate 510(k) number(s):
k944093, k010061

3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | Quantitative determination of total iron | Quantitative determination of total iron |
| Reagent Components | Ferene® (chromophore) Thiourea (prevent Cu interference), Ascorbic acid (reducing agent) | Ferene® (chromophore) Thiourea (prevent Cu interference), Ascorbic acid (reducing agent) |
| Detection | Bi-chromatic endpoint measurement (600 and 700 nm) | Bi-chromatic endpoint measurement (600 and 700 nm) |
| Assay Methodology | Chromatic | Chromatic |
| Calibration | Three point linear calibration same Analytical Range 5 to 1,000 μg/dL | Three point linear calibration same Analytical Range 5 to 1,000 μg/dL |
| Standardization | NIST SRM 937 | NIST SRM 937 |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Sample Type | Serum or heparinized plasma | Serum only |

K. Standard/Guidance Document Referenced (if applicable):

1) Guidance for Industry and FDA Staff - Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use, 11/30/2004
2) Guidance for Industry and FDA Staff; Replacement Reagent and Instrument Family Policy, 12/11/2003
3) Format for Traditional and Abbreviated 510(k)s - Guidance for Industry and FDA Staff, 08/12/2005
4) GP22-A Continuous Quality Improvement Essential Management Approaches
5) ISO 15223 Medical devices – Symbols to be used with medical device labeling

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and information to be supplied

6) ISO 14971-2000 Application of risk analysis to Medical devices
7) NCCLS EP5-A2, Evaluation of Precision Performance of Quantitative Measurement Methods
8) NCCLS EP7-A, Interference Testing in Clinical Chemistry
9) CEN 13640 Stability testing of In-Vitro Diagnostic Devices

L. Test Principle:
Under acidic conditions, iron (Fe+++) bound to the protein transferrin is released. In the presence of the reducing agent ascorbic acid, (Fe+++) is reduced to (Fe++). (Fe++) forms a blue complex with 3-(2-pyridyl)-5,6-bis-2-(5-furyl sulfonic acid)-1,2,4-triazine, disodium salt (Ferene®). The absorbance of the complex, measured using a bichromatic (600, 700 nm) endpoint technique, is directly proportional to the concentration of transferrin-bound iron in the serum.

$$
\mathrm{Fe}^{+++} \rightarrow \text{Transferrin} \rightarrow \mathrm{Fe}^{+++} + \text{Transferrin}
$$

$$
2 \mathrm{Fe}^{+++} + \text{Ascorbic Acid} \rightarrow 2 \mathrm{Fe}^{++} + \text{Dehydroascorbic Acid} + 2 \mathrm{H}^{+}
$$

$$
\mathrm{Fe}^{++} + 3 \text{Ferene}^{\text{®}} \rightarrow \mathrm{Fe}^{++} \rightarrow \text{Ferene}^{\text{®}} 3 \text{complex (absorbs at } 600 \mathrm{~nm)}
$$

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:
Commercially available Bio-Rad Controls and serum and plasma pools were analyzed in duplicate twice a day for 20 days in accordance with the CLSI/NCCLS EP5-A2 Guidelines. All specific performance characteristic tests were run after normal recommended equipment quality control checks were performed on the Dimension® RxL clinical chemistry system. Five samples were run externally at the Washington University School of Medicine, St Louis, Missouri, using the Dimension® IRON method on the Dimension RxL® clinical chemistry system. These samples are designated in the summary chart below with an (E). Seven samples were run internally at Dade Behring research laboratory facility located in Glasgow, Delaware using the Dimension® IRON method on the Dimension RxL® clinical chemistry system. These samples are designated in the summary chart below with an (I). The following sources of variability existed at each of the testing locations: External Site (E): one instrument, one operator, one reagent lot, one calibration interval, samples analyzed n=1 in two separate cups twice a day for 20 days. Internal Site (I): one instrument, one operator, one reagent lot, one calibration interval, samples analyzed n=1 in two separate cups twice a day for 20 days. The repeatability and within-lab precision coefficients of variation (%CV) were calculated by the analysis of variance method according to the Clinical Laboratory Standards Institute (CLSI) Guideline EP5-A2. The sponsors acceptance criteria for Repeatability %CV is less than or equal to 3% and for Within-lab %CV the

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sponsors acceptance criteria less than or equal to $5\%$ . The summary for each of these sites is shown in the table below.

| Material | Mean | | Standard Deviation (%CV) | |
| --- | --- | --- | --- | --- |
| | μg/dL | [μmol/L] | Repeatability | Within-lab |
| Sample Volume = 40 μL | | | | |
| Plasma pool (E) | 101 | 18 | 0.5 [0.09] (0.5) | 0.7 [0.13] (0.7) |
| Serum pool 1 (E) | 95 | 16.9 | 0.5 [0.09] (0.5) | 0.6 [0.11] (0.6) |
| Serum pool 2 (I) | 316 | 56.6 | 1.5 [0.27] (0.5) | 3.5 [0.63] (1.1) |
| Serum pool 3 (I) | 533 | 95.4 | 2.4 [0.43] (0.5) | 4.2 [0.75] (0.8) |
| BioRad Lyphochek® control Level 1 (E) | 231 | 41.3 | 1.3 [0.23] (0.5) | 1.6 [0.29] (0.7) |
| BioRad Lyphochek® control Level 2 (E) | 50 | 8.9 | 0.5 [0.09] (1.1) | 0.9 [0.16] (1.9) |
| BioRad Lyphochek® Anemia control Level 1 (E) | 26 | 4.7 | 0.3 [0.05] (1.3) | 0.5 [0.09] (1.9) |
| Sample Volume = 25 μL | | | | |
| Serum pool 1 (I) | 103 | 18.5 | 0.7 [0.13] (0.6) | 1.0 [0.18] (0.9) |
| Serum pool 2 (I) | 316 | 56.6 | 1.5 [0.27] (0.5) | 3.5 [0.63] (1.1) |
| Serum pool 3 (I) | 530 | 94.9 | 2.9 [0.52] (0.5) | 4.2 [0.75] (0.8) |
| BioRad Lyphochek® Anemia control Level 1 (I) | 32 | 5.7 | 0.3 [0.05] (1.3) | 0.5 [0.09] (1.9) |
| BioRad Multiqual® control Level 3 (I) | 231 | 41.3 | 1.6 [0.29] (0.7) | 2.2 [0.39] (0.9) |

# b. Linearity/assay reportable range:

Linearity was assessed by analyzing solutions of NIST SRM 937. A stock solution of standard reference material was prepared according to the directions specified by NIST. Weighed amounts of SRM937 metal were dissolved in

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hydrochloric acid then diluted with deionized water to a concentration of 5190 $\mu \mathrm{g} / \mathrm{dL}$ . Test concentrations were prepared by dilution of this stock and then sequential mixing to create equally spaced samples ranging from 0 to $2000\mu \mathrm{g} / \mathrm{dL}$ iron. The linearity of iron on the Dimension® RxL by the Dimension® IRON assay was evaluated by comparing observed versus expected values across the expected range. A linear regression analysis was performed on the data and plotted. The observed linearity (using least squares regression analysis) gave the following: Observed = 0.999(Expected) + 0.178; r = 0.9999 from 0 to 2000 $\mu \mathrm{g} / \mathrm{dL}$ .

| Sample | Expected Value, μg/dL | Observed Value, μg/dL |
| --- | --- | --- |
| 1 | 0 | -3 |
| 2 | 250 | 248 |
| 3 | 500 | 503 |
| 4 | 750 | 753 |
| 5 | 1000 | 1003 |
| 6 | 1250 | 1251 |
| 7 | 1500 | 1499 |
| 8 | 1750 | 1747 |
| 9 | 2000 | 2000 |

The assay range claim is 5 to $1000\mu \mathrm{g / dL}$ . The sponsor indicates that values detected as $>1000~\mu \mathrm{g / dL}$ should be manually diluted according to the package insert to obtain results within assay range.

To ascertain device performance over the clinically relevant levels between 5 to $250~\mu \mathrm{g / dL}$ , data with values in this range from the method comparison study were used (n=107). The observed least squares regression statistics were the following: Observed = 1.003(Expected) - 2.64; r = 0.9986 from 9 to 251 $\mu \mathrm{g / dL}$ .

c. Traceability, Stability, Expected values (controls, calibrators, or methods): Calibrator set points are traceable to NIST SRM 937. The calibrator was approved under k060264 as a kit component required but not provided. The shelf-life of the calibrator is 12 months.

# d. Detection limit:

The analytical sensitivity (limit of the blank) represents the lowest concentration of iron that can be distinguished from zero. This analytical sensitivity was defined as the mean value $(n = 20)$ plus two standard deviations of the Level 1 $(0\mathrm{mg / L})$ IRON Calibrator. The Level $1(0\mathrm{mg / L})$ IRON calibrator was run $n = 20$ on one Dimension® RxL clinical chemistry system using one reagent lot on one instrument at both the $40\mathrm{uL}$ and $25\mathrm{uL}$ sample size. The analytical sensitivity of the IRON method is stated as $5\mu \mathrm{g} / \mathrm{dL}$ using a $40~\mu \mathrm{L}$ sample size and $5\mu \mathrm{g} / \mathrm{dL}$ using a $25~\mu \mathrm{L}$ sample size.

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# e. Analytical specificity:

Dimension® IRON was evaluated for interference according to CLSI/NCCLS EP7-A. Bias is the difference in the results between the control sample (without the interferent) and the test sample (contains the interferent) expressed in percent. The sponsor considered bias exceeding $10\%$ to be interference. Iron dextran at a concentration of $60~\mathrm{ug / mL}$ increases the IRON result by $63~\mu \mathrm{g / dL}$ at an IRON concentration of $36~\mu \mathrm{g / dL}$ [and by $69~\mu \mathrm{g / dL}$ at an IRON concentration of 131 $\mu \mathrm{g / dL}$ . The following substances do not interfere with the IRON method when present in serum in the amounts indicated. Systematic inaccuracies (bias) due to these substances are less than $10\%$ at an iron concentration of 26 to $38~\mu \mathrm{g / dL}$ and 118 to $136~\mu \mathrm{g / dL}$ .

| Compound | Concentration [SI Units] | Compound | Concentration [SI Units] |
| --- | --- | --- | --- |
| Acarbose | 180 μg/mL [200 μmol/L] | Heparin | 8 U/mL [8000 U/L] |
| Acetaminophen | 20 mg/dL [1323 μmol/L] | Hydrochlorothiazide | 5.9 μg/mL [198 μmol/L] |
| Allopurinol | 40 μg/dL [253 μmol/L] | Ibuprofen | 50 mg/dL [2425 μmol/L] |
| Amikacin | 15 mg/dL [256 μmol/L] | Immunoglobulin G (IgG) | 5 g/dL [50 g/L] |
| Amiodorone HCl | 6 μg/mL [8.8 μmol/L] | Insulin | 0.018 u/mL [18 U/L] |
| Ampicillin | 5.3 mg/dL [152 μmol/L] | Isosorbide dinitrate | 150 ng/mL [635 μmol/L] |
| Ascorbic Acid | 5 mg/dL [227 μmol/L] | Lidocaine | 6 mg/dL [256 μmol/L] |
| Atenolol | 1 mg/dL [37.5 μmol/L] | Lithium | 3.5 mg/dL [5043 μmol/L] |
| Atorvastatin | 600 μg/L [0.4 umol/L] | Losartan potassium | 10 mg/dL [0.22 mmol/L] |
| Caffeine | 10 mg/dL [515 μmol/L] | Magnesium | 15 mg/dL [1.6 mmol/L] |
| Calcitriol | 0.3 μg/mL [0.7 μmol/L] | Metformin | 40 μg/mL [241 μmol/L] |
| Calcium | 15 mg/dL [1.4 mmol/L] | Nateglinide | 72 μg/mL [227 μmol/L] |
| Captopril | 22 μg/mL [101 μmol/L] | Niacin | 1.2 mg/mL [9.7 mmol/L] |
| Carbamazepine | 12 mg/dL [508 μmol/L] | Nicotine | 2 mg/dL [123 μmol/L] |
| Chloramphenicol | 25 mg/dL [774 μmol/L] | Nitrofurantoin | 4 μg/mL [17 μmol/L] |
| Chlordiazepoxide | 2 mg/dL [66 μmol/L] | Nortryptiline | 1 μg/mL [3 μmol/L] |
| Chlorpromazine | 5 mg/dL [157 μmol/L] | Paricalcitol | 8.4 ng/mL [20.2 nmol/L] |
| Cholesterol | 500 mg/dL [12.9 mmol/L] | Penicillin G | 25 U/mL [25,000 U/L] |
| Cinacalcet hydrochloride | 18 ng/mL [46 nmol/L] | Pentobarbital | 10 mg/dL [442 μmol/L] |
| Cimetidine | 10 mg/dL [396 μmol/L] | Phenobarbital | 15 mg/dL [646 μmol/L] |
| Copper | 300 μg/dL [22.3 μmol/L] | Phenytoin | 10 mg/dL [396 μmol/L] |
| Creatinine | 30 mg/dL [2652 μmol/L] | Primidone | 10 mg/dL [458 μmol/L] |
| Deferoxamine | 250 ng/dL [3.8 nmol/L] | Propoxyphene | 0.4 mg/dL [11.8 μmol/L] |
| Dextran 40 | 6000 mg/dL [1500 μmol/L] | Protein: Albumin | 6 g/dL [60 g/L] |
| Diazepam | 2 mg/dL [70 μmol/L] | Protein: Total | 12 g/dL [120 g/L] |
| Diltiazem hydrochloride | 40 ng/mL [89 nmol/L] | Pyridoxine | 6 ng/mL [29 nmol/L] |
| Dexamethasone | 100 μg/mL [100 μmol/L] | Protein: Propoxyphene | 0.25 μg/mL [100 μg/mL] |
| Dextrandol | 100 μg/mL [100 μmol/L] | Protein: Propoxyphene | 0.25 μg/mL [100 μg/mL] |
| Dextrandol 100 | 100 μg/mL [100 μmol/L] | Protein: Propoxyphene | 0.25 μg/mL [100 μg/mL] |
| Dextrandol 1000 | 100 μg/mL [100 μmol/L] | Protein: Propoxyphene | 0.25 μg/mL [100 μg/mL] |
| Dextrandol 10000 | 100 μg/mL [100 μmol/L] | Protein: Propoxyphene | 0.25 μg/mL [100 μg/mL] |
| Dextrandol 100000 | 100 μg/mL [1000 μmol/L] | Protein: Propoxyphene | 0.25 μg/mL [100 μg/mL] |

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The IRON method (using the standard sample size of $40~\mathrm{uL}$ ) was evaluated for interference according to CLSI/NCCLS EP7-A. The sponsor defined the bias as the difference in the results between the control sample (without the interferent) and the test sample (contains the interferent) expressed in percent. The sponsor considered bias exceeding $10\%$ to be interference.

| Substance Tested | Test Concentration [SI units] | IRON Concentration [SI Units] | Bias % |
| --- | --- | --- | --- |
| Hemoglobin (hemolysate) | 50 mg/dL [0.03 mmol/L] (monomer) | 107 μg/dL [19.3 μmol/L] | <10% |
| | 200 mg/dL [0.12 mmol/L] (monomer) | | +10% |
| Bilirubin (unconjugated) | 80 mg/dL [1368 μmol/L] | 107 μg/dL [19.3 μmol/L] | <10% |
| Lipemia (Intralipid®) | 1000 mg/dL [11.43 mmol/L] | 107 μg/dL [19.3 μmol/L] | <10% |
| | 3000mg/dL [34.29 mmol/L] | | +71% |

The IRON method (using the reduced sample size of $25~\mathrm{uL}$ ) was evaluated for interference according to CLSI/NCCLS EP7-A11. The sponsor defined the bias as the difference in the results between the control sample (without the interferent) and the test sample (contains the interferent) expressed in percent. The sponsor considered bias exceeding $10\%$ to be interference.

| Substance Tested | Test Concentration [SI units] | IRON Concentration [SI Units] | Bias % |
| --- | --- | --- | --- |
| Hemoglobin | 50 mg/dL [0.03 mmol/L] | 55μg/dL [9.8 μmol/L] | <10% |
| (hemolysate) | 200 mg/dL [0.12 mmol/L] | 200μg/dL [0.12 mmol/L] | +10% |
| Bilirubin | 80 mg/dL [1368 μmol/L] | 107μg/dL [19.3 μmol/L] | +10% |
| Lipemia | 1000 mg/dL [11.43 mmol/L] | 107μg/dL [19.3 μmol/L] | +10% |

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| Substance Tested | Test Concentration [SI units] | IRON Concentration [SI Units] | Bias % |
| --- | --- | --- | --- |
| (hemolysate) | (monomer)
200 mg/dL [0.12 mmol/L]
(monomer) | 55μg/dL [9.8 μmol/L] | +22% |
| Bilirubin (unconjugated) | 80 mg/dL [1368 μmol/L] | 53 μg/dL [9.5μmol/L] | <10% |
| Lipemia (Intralipid®) | 3000mg/dL [34.29 mmol/L] | 27 μg/dL [4.8μmol/L] | <10% |

f. Assay cut-off:
Not applicable.

2. Comparison studies:

a. Method comparison with predicate device:

A total of 147 serum samples were run using the IRN and IRON methods on the Dimension® RxL clinical chemistry system. Ninety-nine (99) individual native serum patient samples were tested. Due to the difficulty to obtain native individual samples containing iron concentrations that adequately span the entire assay range of the Dimension IRON assay, some spiked samples were added to the method comparison study. 48 different individual serum samples were spiked with various amounts of NIST-937 reference iron material.

The distribution of samples included 10 visibly icteric and 10 visibly lipemic samples. Samples containing hemoglobin have been identified as a known interferent for the Dimension® IRON method and were not included in this study. This limitation is described in the "Specimen Collection" section of the package insert. The following represents the sample breakdown across the assay range.

| Range of Iron Concentration | Number of Specimens Tested |
| --- | --- |
| <50 μg/dL | 41 |
| 50-150 μg/dL | 51 |
| 150-300 μg/dL | 18 |
| 300-1000 μg/dL | 37 |
| Total | 147 |

Linear regression analysis gave the following relationship:
$$ \text{Device} = 0.980(\text{Predicate}) - 0.488; r = 0.9996 $$

b. Matrix comparison:

One hundred and twenty nine (129) matched sets of serum and plasma specimens

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were analyzed to estimate bias between serum and either lithium or sodium heparin plasma sample types.

Serum and heparinized (lithium or sodium heparin) plasma are the recommended specimens for the Dimension® Automated iron (IRON) assay (DF85). In order to compare specimen types with analyte values that span the assay range, fifty (50) of the samples were spiked with varying amounts of $\mathrm{FeCl}_2$ .

No clinically significant difference was observed between serum and plasma samples. Results are summarized in the table below.

| Comparison | Slope | Y-Intercept | r |
| --- | --- | --- | --- |
| Serum vs Na heparin plasma | 0.988 | 0.804 | 0.999 |
| Serum vs Li heparin plasma | 0.985 | 1.42 | 0.999 |
| Li heparin vs Na heparin plasma | 1.00 | -0.590 | 0.9997 |

To determine the effect of freezing and thawing on iron in 20 serum and 20 lithium hepranized plasma samples, samples were run fresh, in duplicate, on the Dimension® RxL clinical chemical system. The samples were frozen, thawed and then run in duplicate on the Dimension® RxL clinical chemical system. A bias was calculated by subtracting the mean of the frozen results from the mean of fresh results. The average bias for both serum and lithium heparinized samples was -2. No statistical difference was observed for either serum or plasma.

# 3. Clinical studies:

a. Clinical Sensitivity: Not applicable.
b. Clinical specificity: Not applicable.
c. Other clinical supportive data (when a. and b. are not applicable): Not applicable.

# 4. Clinical cut-off: Not applicable.

# 5. Expected values/Reference range:

The reference range for total iron is indicated to be:

Males: 65-175 $\mu$ g/dL [11.6-31.3 $\mu$ mol/L]

Females: $50 - 170~\mu \mathrm{g / dL}$ [9.0-30.4 $\mu \mathrm{mol} / \mathrm{L}]$

These values were quoted from the following reference:

Kaplan LA, Psece AJ. Clinical Chemistry Theory, Analysis, and Correlation, 3rd

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ed. St. Louis; Mosby, Inc., 1996: p 699, 713-714.

Normal reference intervals can differ by as much as 35% between commercial iron methods, therefore the sponsor advises customers that each laboratory establish its own expected values for iron as performed on the Dimension® system.

N. Proposed Labeling:

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

O. Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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