Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes standard clinical chemistry assays based on colorimetric reactions and spectrophotometric measurements. There is no mention of AI or ML in the intended use, device description, or performance studies.

Therapeutic

No
The devices mentioned are reagents for in vitro diagnostic tests, used to measure concentrations of substances in patient samples for diagnosis and treatment. They are not therapeutic devices that directly treat or mitigate a disease.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the measurements obtained from these reagents are "used in the diagnosis and treatment of numerous diseases." This directly indicates a diagnostic purpose.

SaMD (Software as a Medical Device)

No

The device description clearly outlines chemical reactions and measurements of color intensity, indicating a physical reagent and a clinical chemistry system (hardware) are involved in the intended use.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The "Intended Use / Indications for Use" section explicitly states that the reagents are "intended for the quantitative determination of [analyte] concentration in serum and lithium heparin plasma". It also mentions that these measurements are used in the "diagnosis and treatment of numerous diseases".
For in vitro diagnostic use only: Each reagent's intended use statement concludes with "For in vitro diagnostic use only." This is a clear indicator that the device is intended for use outside of the body to examine specimens.
Device Description: The device description details how the reagents interact with the sample (serum or plasma) to produce a measurable result (color change or absorbance) that is proportional to the concentration of the analyte. This process is performed in vitro.
Care Setting: The intended user is specified as "clinical laboratories or physician office laboratories," which are typical settings for performing in vitro diagnostic tests.

All of these points align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens, including blood, tissues, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

ACE Albumin Reagent is intended for the quantitative determination of albumin concentration in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

ACE Total Protein Reagent is intended for the quantitative determination of total protein concentration in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Total protein measurements are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

ACE Calcium-Arsenazo Reagent is intended for the quantitative determination of calcium concentration in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

ACE Inorganic Phosphorus U.V. Reagent is intended for the quantitative determination of inorganic phosphorus concentration in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Measurements of inorganic phosphorus are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases and vitamin D imbalance. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

Product codes

CIX, CEK, CJY, CEO

Device Description

In the ACE Albumin Reagent assay, Bromcresol green binds specifically to albumin to form a green colored complex, which is measured bichromatically at 629 nm/692 nm. The intensity of color produced is directly proportional to the albumin concentration in the sample.

In the ACE Total Protein Reagent assay, cupric ions react with the peptide bonds of proteins under alkaline conditions to form a violet colored complex, which is measured bichromatically at 544 nm/692 nm. The intensity of color produced is directly proportional to the total protein concentration in the sample.

In the ACE Calcium-Arsenazo Reagent assay, calcium reacts with Arsenazo III in an acidic solution to form a blue-purple colored complex, which is measured bichromatically at 647 nm/692 nm. The intensity of color produced is directly proportional to the calcium concentration in the sample.

In the ACE Inorganic Phosphorus U.V. Reagent assay, under acidic conditions, inorganic phosphorus in serum reacts with ammonium molybdate to form an unreduced phosphomolybdate complex, which absorbs strongly at 340 nm. The increase in absorbance, measured bichromatically at 340 nm/378 nm, is directly proportional to the amount of phosphorus in the sample.

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 or 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

The stability of the reagents and specimen samples, precision, detection limits (LoB, LoD, LoQ), linearity, and interference data were evaluated in-house and through "Performance data for the Alfa Wassermann ACE Reagents run on the Alfa Wassermann ACE, ACE Alera and ACE Axcel Clinical Chemistry Systems".

Precision:

ACE Albumin Reagent:
- Serum Low: ACE Mean 4.1 (SD 0.07, 1.6% CV), Alera Mean 4.1 (SD 0.04, 1.1% CV), Axcel Mean 4.1 (SD 0.04, 1.0% CV)
- Plasma Low: ACE Mean 3.8 (SD 0.06, 1.7% CV), Alera Mean 3.7 (SD 0.05, 1.4% CV), Axcel Mean 3.7 (SD 0.06, 1.6% CV)
- Serum Mid: ACE Mean 5.4 (SD 0.10, 1.8% CV), Alera Mean 5.3 (SD 0.06, 1.1% CV), Axcel Mean 5.3 (SD 0.03, 0.6% CV)
- Plasma Mid: ACE Mean 5.0 (SD 0.07, 1.4% CV), Alera Mean 5.0 (SD 0.08, 1.7% CV), Axcel Mean 4.9 (SD 0.05, 1.1% CV)
- Serum High: ACE Mean 6.5 (SD 0.11, 1.6% CV), Alera Mean 6.5 (SD 0.08, 1.3% CV), Axcel Mean 6.4 (SD 0.09, 1.3% CV)
- Plasma High: ACE Mean 6.2 (SD 0.10, 1.7% CV), Alera Mean 6.1 (SD 0.10, 1.6% CV), Axcel Mean 6.1 (SD 0.08, 1.3% CV)
- POL data for Albumin shows consistent precision across in-house and three POL labs for ACE and ACE Alera systems.
ACE Total Protein Reagent:
- Serum Low: ACE Mean 6.7 (SD 0.07, 1.0% CV), Alera Mean 6.7 (SD 0.05, 0.8% CV), Axcel Mean 6.8 (SD 0.09, 1.3% CV)
- Plasma Low: ACE Mean 7.2 (SD 0.06, 0.9% CV), Alera Mean 7.1 (SD 0.09, 1.2% CV), Axcel Mean 7.2 (SD 0.07, 0.9% CV)
- Serum Mid: ACE Mean 8.4 (SD 0.11, 1.3% CV), Alera Mean 8.4 (SD 0.08, 1.0% CV), Axcel Mean 8.4 (SD 0.11, 1.4% CV)
- Plasma Mid: ACE Mean 8.8 (SD 0.06, 0.7% CV), Alera Mean 8.7 (SD 0.1, 1.2% CV), Axcel Mean 8.8 (SD 0.08, 0.9% CV)
- Serum High: ACE Mean 10.1 (SD 0.08, 0.8% CV), Alera Mean 10.0 (SD 0.09, 0.9% CV), Axcel Mean 10.1 (SD 0.09, 0.9% CV)
- Plasma High: ACE Mean 10.3 (SD 0.14, 1.4% CV), Alera Mean 10.2 (SD 0.14, 1.3% CV), Axcel Mean 10.4 (SD 0.10, 1.0% CV)
- POL data for Total Protein shows consistent precision across in-house and three POL labs for ACE and ACE Alera systems.
ACE Calcium-Arsenazo Reagent:
- Serum Low: ACE Mean 9.3 (SD 0.25, 2.7% CV), Alera Mean 9.3 (SD 0.22, 2.4% CV), Axcel Mean 9.3 (SD 0.17, 1.8% CV)
- Plasma Low: ACE Mean 8.4 (SD 0.2, 2.4% CV), Alera Mean 8.3 (SD 0.17, 2.0% CV), Axcel Mean 8.3 (SD 0.11, 1.4% CV)
- Serum Mid: ACE Mean 11.7 (SD 0.2, 1.7% CV), Alera Mean 11.6 (SD 0.14, 1.2% CV), Axcel Mean 11.6 (SD 0.11, 0.9% CV)
- Plasma Mid: ACE Mean 10.7 (SD 0.20, 1.9% CV), Alera Mean 10.7 (SD 0.15, 1.4% CV), Axcel Mean 10.7 (SD 0.13, 1.2% CV)
- Serum High: ACE Mean 13.9 (SD 0.2, 1.4% CV), Alera Mean 13.8 (SD 0.19, 1.4% CV), Axcel Mean 13.8 (SD 0.11, 0.8% CV)
- Plasma High: ACE Mean 13.0 (SD 0.26, 2.0% CV), Alera Mean 12.9 (SD 0.14, 1.1% CV), Axcel Mean 13.1 (SD 0.18, 1.4% CV)
- POL data for Calcium-Arsenazo shows consistent precision across in-house and three POL labs for ACE and ACE Alera systems.
ACE Inorganic Phosphorus U.V. Reagent:
- Serum Low: ACE Mean 3.5 (SD 0.17, 5.0% CV), Alera Mean 3.4 (SD 0.14, 4.0% CV), Axcel Mean 3.5 (SD 0.14, 4.1% CV)
- Plasma Low: ACE Mean 3.1 (SD 0.18, 5.9% CV), Alera Mean 3.0 (SD 0.15, 5.0% CV), Axcel Mean 3.1 (SD 0.19, 6.1% CV)
- Serum Mid: ACE Mean 10.2 (SD 0.05, 0.5% CV), Alera Mean 9.9 (SD 0.08, 0.8% CV), Axcel Mean 10.2 (SD 0.12, 1.2% CV)
- Plasma Mid: ACE Mean 9.8 (SD 0.09, 0.9% CV), Alera Mean 9.6 (SD 0.08, 0.8% CV), Axcel Mean 9.9 (SD 0.12, 1.2% CV)
- Serum High: ACE Mean 17.0 (SD 0.26, 1.6% CV), Alera Mean 16.6 (SD 0.22, 1.3% CV), Axcel Mean 17.3 (SD 0.30, 1.7% CV)
- Plasma High: ACE Mean 16.7 (SD 0.24, 1.4% CV), Alera Mean 16.3 (SD 0.29, 1.8% CV), Axcel Mean 16.9 (SD 0.32, 1.9% CV)
- POL data for Inorganic Phosphorus U.V. shows consistent precision across in-house and three POL labs for ACE and ACE Alera systems.

Matrix Comparison (Serum vs. Plasma):

ACE Albumin Reagent:
- ACE (55 pairs, 0.3-6.8 g/dL): Slope 0.991, Intercept 0.03, Correlation 0.9874
- ACE Alera (56 pairs, 0.3-6.8 g/dL): Slope 1.002, Intercept -0.01, Correlation 0.9905
- ACE Axcel (56 pairs, 0.7-6.7 g/dL): Slope 0.956, Intercept 0.20, Correlation 0.9850
ACE Total Protein Reagent:
- ACE (56 pairs, 0.5-12.3 g/dL): Slope 1.001, Intercept 0.12, Correlation 0.9798
- ACE Alera (56 pairs, 0.5-12.0 g/dL): Slope 0.999, Intercept 0.14, Correlation 0.9840
- ACE Axcel (81 pairs, 0.5-13.9 g/dL): Slope 0.994, Intercept 0.34, Correlation 0.9885
ACE Calcium-Arsenazo Reagent:
- ACE (56 pairs, 1.0-13.7 mg/dL): Slope 1.006, Intercept -0.01, Correlation 0.9824
- ACE Alera (56 pairs, 1.0-13.7 mg/dL): Slope 1.008, Intercept -0.06, Correlation 0.9793
- ACE Axcel (81 pairs, 0.7-15.0 mg/dL): Slope 0.978, Intercept 0.33, Correlation 0.9911
ACE Inorganic Phosphorus Reagent:
- ACE (100 pairs, 1.3-19.3 mg/dL): Slope 1.042, Intercept -0.26, Correlation 0.9927
- ACE Alera (102 pairs, 1.3-19.3 mg/dL): Slope 1.049, Intercept -0.28, Correlation 0.9928
- ACE Axcel (56 pairs, 0.5-19.8 mg/dL): Slope 0.999, Intercept 0.04, Correlation 0.9950

Detection Limits (for ACE Alera Clinical Chemistry System):

ALB: LoB 0.08 g/dL, LoD 0.09 g/dL, LoQ 0.09 g/dL
TP: LoB 0.08 g/dL, LoD 0.13 g/dL, LoQ 0.20 g/dL
CA: LoB 0.09 mg/dL, LoD 0.11 mg/dL, LoQ 0.23 mg/dL
PHOS: LoB 0.25 mg/dL, LoD 0.35 mg/dL, LoQ 0.35 mg/dL

Linearity (for ACE Alera Clinical Chemistry System):

ALB: Linear to 7.6 g/dL (y = 0.980x + 0.01, r2 = 0.9982)
TP: Linear to 15.1 g/dL (y = 0.991x + 0.04, r2 = 0.9979)
CA: Linear to 16.5 mg/dL (y = 0.992x + 0.27, r2 = 0.9990)
PHOS: Linear to 21 mg/dL (y = 1.001x + 0.03, r2 = 0.9995)

Interference (for ACE Alera Clinical Chemistry System):

No significant interference at or below specified levels for Icterus, Hemolysis, Lipemia, and Ascorbic Acid for ALB, TP, CA, PHOS.

Key Metrics

Precision: Reported as Mean, Within-Run Standard Deviation (SD) and Coefficient of Variation (%CV), and Total SD and %CV. Specific values are provided in the Summary of Performance Studies for various analytes and systems (ACE, Alera, Axcel).
Correlation: Pearson correlation coefficient (r and r2) is provided for matrix comparison and method comparison studies.
Regression: Slope and Intercept for linear regression equations (y = mx + b) are provided for matrix comparison and method comparison studies.
Standard Error of Estimate: Quantifies the average distance that observed values fall from the regression line.
Confidence Interval (CI) for Slope and Intercept: Provides a range within which the true slope and intercept are likely to fall.
Detection Limits: Limit of Blank (LoB), Limit of Detection (LoD), and Limit of Quantitation (LoQ).

Predicate Device(s)

K930104, K113253, K113374

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 862.1035 Albumin test system.

(a)
Identification. An albumin test system is a device intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.(b)
Classification. Class II.

Summary

0

K131488

| 510(k) Owner: | Alfa Wassermann Diagnostic Technologies, LLC
4 Henderson Drive
West Caldwell, NJ 07006 | | |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|--------------|
| Contact: | Hkatz@AlfaWassermannUS.com
Hyman Katz, Ph.D.
Phone: 973-852-0158
Fax: 973-852-0237 | | AUG 1 9 2013 |
| Date Summary Prepared: | July 12, 2013 | | |
| Device: | Trade Name: | ACE Albumin Reagent | |
| | Classification: | Class 2 | |
| | Common/Classification Name: | Bromcresol Green Dye-Binding, Albumin
(21 C.F.R. § 862.1035)
Product Code CIX | |
| | Trade Name: | ACE Total Protein Reagent | |
| | Classification: | Class 2 | |
| | Common/Classification Name: | Biuret (Colorimetric), Total Protein
(21 C.F.R. § 862.1635)
Product Code CEK | |
| | Trade Name: | ACE Calcium-Arsenazo Reagent | |
| | Classification: | Class 2 | |
| | Common/Classification Name: | Azo Dye, Calcium
(21 C.F.R. § 862.1445)
Product Code CJY | |
| | Trade Name: | ACE Inorganic Phosphorus U.V. Reagent | |
| | Classification: | Class 1 | |
| | Common/Classification Name: | Phosphomolybdate (Colorimetric), Inorganic
Phosphorus
(21 C.F.R. § 862.1580)
Product Code CEO | |
| Predicate Devices: | Manufacturer for reagent system predicates:
Alfa Wassermann ACE and ACE Axcel Clinical Chemistry Systems and ACE
Reagents (K930104, K113253, K113374) | | |

1

| Device
Descriptions: | In the ACE Albumin Reagent assay, Bromcresol green binds specifically to albumin to
form a green colored complex, which is measured bichromatically at 629 nm/692 nm.
The intensity of color produced is directly proportional to the albumin concentration in
the sample.

In the ACE Total Protein Reagent assay, cupric ions react with the peptide bonds of
proteins under alkaline conditions to form a violet colored complex, which is measured
bichromatically at 544 nm/692 nm. The intensity of color produced is directly
proportional to the total protein concentration in the sample.

In the ACE Calcium-Arsenazo Reagent assay, calcium reacts with Arsenazo III in an
acidic solution to form a blue-purple colored complex, which is measured
bichromatically at 647 nm/692 nm. The intensity of color produced is directly
proportional to the calcium concentration in the sample.

In the ACE Inorganic Phosphorus U.V. Reagent assay, under acidic conditions,
inorganic phosphorus in serum reacts with ammonium molybdate to form an unreduced
phosphomolybdate complex, which absorbs strongly at 340 nm. The increase in
absorbance, measured bichromatically at 340 nm/378 nm, is directly proportional to the
amount of phosphorus in the sample. |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | Indications for Use:

ACE Albumin Reagent is intended for the quantitative determination of albumin
concentration in serum and lithium heparin plasma using the ACE, ACE Alera, and
ACE Axcel Clinical Chemistry Systems. Albumin measurements are used in the
diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.
This test is intended for use in clinical laboratories or physician office laboratories. For
in vitro diagnostic use only.

ACE Total Protein Reagent is intended for the quantitative determination of total
protein concentration in serum and lithium heparin plasma using the ACE, ACE Alera,
and ACE Axcel Clinical Chemistry Systems. Total protein measurements are used in
the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone
marrow as well as other metabolic or nutritional disorders. This test is intended for use
in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

ACE Calcium-Arsenazo Reagent is intended for the quantitative determination of
calcium concentration in serum and lithium heparin plasma using the ACE, ACE Alera,
and ACE Axcel Clinical Chemistry Systems. Calcium measurements are used in the
diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal
disease and tetany (intermittent muscular contractions or spasms). This test is intended
for use in clinical laboratories or physician office laboratories. For in vitro diagnostic
use only. |
| | ACE Inorganic Phosphorus U.V. Reagent is intended for the quantitative determination
of inorganic phosphorus concentration in serum and lithium heparin plasma using the
ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Measurements of
inorganic phosphorus are used in the diagnosis and treatment of various disorders.
including parathyroid gland and kidney diseases and vitamin D imbalance. This test is
intended for use in clinical laboratories or physician office laboratories. For in vitro
diagnostic use only. |
| Technological
Characteristics: | ACE Albumin Reagent consists of a single reagent bottle. The reagent contains
Bromcresol green and acetate buffer. |
| | ACE Total Protein Reagent consists of a single reagent bottle. The reagent contains
copper sulfate, sodium potassium tartrate, potassium iodide and sodium hydroxide. |
| | ACE Calcium-Arsenazo Reagent consists of a single reagent bottle. The Reagent
contains Arsenazo III. |
| | ACE Inorganic Phosphorus U.V. Reagent consists of a single reagent bottle. The
reagent contains ammonium molybdate and sulfuric acid. |

.

2

·

3

	Comparison of similarities and differences with predicate device
Device Comparison
with Predicate	ACE Albumin Reagent
ALB	Candidate Device	Predicate Device
K930104
(ACE ALB)
Intended Use/
Indications for Use	The ACE Albumin Reagent is intended
for the quantitative determination of
albumin concentration.	Same
Platforms	ACE, ACE Alera®, and ACE Axcel
Clinical Chemistry Systems	ACE Clinical Chemistry System
Method	Photometric	Same
Calibration
Stability	30 days	Same
On-Board Stability	30 Days	Same
Sample Type	Serum and lithium heparin plasma	Serum
Sample Volume	3 µL	Same
Reaction Volume	463 µL	Same
Expected Values	3.5 – 5.2 g/dL	Same
Measuring Range	0.1 – 7.6 g/dL	Same
Sample Stability	Specimen stable at 4°C for up to 72 hours
and frozen at -20°C for 6 months or
indefinitely at -70°C.	Same
	Calcium-Arsenazo	Candidate Device	Predicate Device
K930104
(ACE Calcium-Arsenazo)
Device
Comparison
with Predicate	Intended Use/
Indications for Use	ACE Calcium-Arsenazo Reagent is
intended for the quantitative
determination of calcium.	Same
	Platforms	ACE, ACE Alera®, and ACE Axcel
Clinical Chemistry Systems	ACE Clinical Chemistry System
	Method	Photometric	Same
	Calibration
Stability	30 Days	Same
	On-Board Stability	30 Days	Same
	Sample Type	Serum and lithium heparin plasma	Serum
	Sample Volume	3 µL	Same
	Reaction Volume	318 µL	Same
	Expected Values	8.5 - 10.2 mg/dL	Same
	Measuring Range	0.2 - 16.5 mg/dL	Same
	Sample Stability	Specimen stable for 7 days at 20-25°C, 3
weeks at 4-8°C, and 8 months at -20°C	Same
		ACE Inorganic Phosphorus U.V. Reagent
	Inorganic
Phosphorus	Candidate Device	Predicate Device
K930104
(ACE Inorganic Phosphorus)
	Intended Use/
Indications for Use	ACE Inorganic Phosphorus U.V.
Reagent is intended for the
quantitative determination of	Same
		inorganic phosphorus.
	Platforms	ACE, ACE Alera®, and ACE Axcel
Clinical Chemistry Systems	ACE Clinical Chemistry System
	Method	Photometric	Same
	Calibration Stability	30 Days	Same
	On-Board Stability	30 Days	Same
	Sample Type	Serum and lithium heparin plasma	Serum
	Sample Volume	3 µL	Same
	Reaction Volume	218 µL	Same
	Expected Values	2.7 - 4.5 mg/dL	Same
	Measuring Range	0.4-21 mg/dL	Same

4

·

5

Performance data for the Alfa Wassermann ACE Reagents run on the Alfa Wassermann ACE, ACE Alera and ACE Axcel Clinical Chemistry Systems

In-House Precision: Serum vs. Plasma – ACE Albumin Reagent

	Precision (SD, %CV)
Albumin
g/dL	ACE
Mean	Within-
Run	Total	Alera
Mean	Within-
Run	Total	Axcel
Mean	Within-
Run	Total
Serum Low	4.1	0.05, 1.3%	0.07, 1.6%	4.1	0.04, 0.9%	0.04, 1.1%	4.1	0.02, 0.5%	0.04, 1.0%
Plasma Low	3.8	0.06, 1.7%	0.06, 1.7%	3.7	0.03, 0.8%	0.05, 1.4%	3.7	0.06, 1.6%	0.06, 1.6%
Serum Mid	5.4	0.08, 1.6%	0.10, 1.8%	5.3	0.05, 1.0%	0.06, 1.1%	5.3	0.03, 0.6%	0.03, 0.6%
Plasma Mid	5.0	0.05, 1.0%	0.07, 1.4%	5.0	0.08, 1.7%	0.08, 1.7%	4.9	0.04, 0.9%	0.05, 1.1%
Serum High	6.5	0.07, 1.1%	0.11, 1.6%	6.5	0.05, 0.8%	0.08, 1.3%	6.4	0.06, 1.0%	0.09, 1.3%
Plasma High	6.2	0.09, 1.5%	0.10, 1.7%	6.1	0.08, 1.3%	0.10, 1.6%	6.1	0.05, 0.9%	0.08, 1.3%

In-House Precision: Serum vs. Plasma - ACE Total Protein Reagent

Precision (SD, %CV)
Total
Protein
g/dL	ACE
Mean	Within-
Run	Total	Alera
Mean	Within-
Run	Total	Axcel
Mean	Within-
Run	Total
Serum Low	6.7	0.06, 1.0%	0.07, 1.0%	6.7	0.05, 0.7%	0.05, 0.8%	6.8	0.08, 1.1%	0.09, 1.3%
Plasma Low	7.2	0.06, 0.9%	0.06, 0.9%	7.1	0.08, 1.1%	0.09, 1.2%	7.2	0.05, 0.8%	0.07, 0.9%
Serum Mid	8.4	0.11, 1.3%	0.11, 1.3%	8.4	0.08, 1.0%	0.08, 1.0%	8.4	0.07, 0.8%	0.11, 1.4%
Plasma Mid	8.8	0.04, 0.5%	0.06, 0.7%	8.7	0.06, 0.7%	0.1, 1.2%	8.8	0.07, 0.8%	0.08, 0.9%
Serum High	10.1	0.07, 0.7%	0.08, 0.8%	10.0	0.07, 0.7%	0.09, 0.9%	10.1	0.07, 0.7%	0.09, 0.9%
Plasma High	10.3	0.13, 1.3%	0.14, 1.4%	10.2	0.11, 1.1%	0.14, 1.3%	10.4	0.08, 0.8%	0.10, 1.0%

In-House Precision: Serum vs. Plasma - ACE Calcium-Arsenazo Reagent

Precision (SD, %CV)
Calcium-
Arsenazo
mg/dL	ACE
Mean	Within-
Run	Total	Alera
Mean	Within-
Run	Total	Axcel
Mean	Within-
Run	Total
Serum Low	9.3	0.12, 1.3%	0.25, 2.7%	9.3	0.09, 0.9%	0.22, 2.4%	9.3	0.08, 0.8%	0.17, 1.8%
Plasma Low	8.4	0.04, 0.5%	0.2, 2.4%	8.3	0.10, 1.2%	0.17, 2.0%	8.3	0.08, 0.9%	0.11, 1.4%
Serum Mid	11.7	0.18, 1.6%	0.2, 1.7%	11.6	0.14, 1.2%	0.14, 1.2%	11.6	0.1, 0.9%	0.11, 0.9%
Plasma Mid	10.7	0.19, 1.7%	0.20, 1.9%	10.7	0.13, 1.2%	0.15, 1.4%	10.7	0.12, 1.2%	0.13, 1.2%
Serum High	13.9	0.20, 1.4%	0.2, 1.4%	13.8	0.19, 1.4%	0.19, 1.4%	13.8	0.09, 0.7%	0.11, 0.8%
Plasma High	13.0	0.25, 1.9%	0.26, 2.0%	12.9	0.13, 1.0%	0.14, 1.1%	13.1	0.15, 1.2%	0.18, 1.4%

6

In-House Precision: Serum vs. Plasma - ACE Inorganic Phosphorus Reagent
Precision (SD, %CV)
Inorganic
Phosphorus
U.V.
mg/dL	ACE
Mean	Within-
Run	Total	Alera
Mean	Within-
Run	Total	Axcel
Mean	Within-
Run	Total
Serum Low	3.5	0.15, 4.4%	0.17, 5.0%	3.4	0.11, 3.1%	0.14, 4.0%	3.5	0.11, 3.1%	0.14, 4.1%
Plasma Low	3.1	0.16, 5.1%	0.18, 5.9%	3.0	0.11, 3.7%	0.15, 5.0%	3.1	0.15, 5.0%	0.19, 6.1%
Serum Mid	10.2	0.04, 0.3%	0.05, 0.5%	9.9	0.08, 0.8%	0.08, 0.8%	10.2	0.04, 0.4%	0.12, 1.2%
Plasma Mid	9.8	0.09, 0.9%	0.09, 0.9%	9.6	0.07, 0.8%	0.08, 0.8%	9.9	0.06, 0.6%	0.12, 1.2%
Serum High	17.0	0.26, 1.5%	0.26, 1.6%	16.6	0.22, 1.3%	0.22, 1.3%	17.3	0.28, 1.6%	0.30, 1.7%
Plasma High	16.7	0.23, 1.4%	0.24, 1.4%	16.3	0.24, 1.5%	0.29, 1.8%	16.9	0.30, 1.8%	0.32, 1.9%

.

7

Performance Data: In-House Precision -Serum vs.

Plasma

Performance data for the Alfa Wassermann ACE Reagents run on the Alfa Wassermann ACE, ACE Alera and ACE Axcel Clinical Chemistry Systems

In-House Matrix Comparison: Serum vs. Plasma – ACE Albumin Reagent

System	Range	Results - Serum vs. Plasma
ACE
55 pairs	0.3-6.8 g/dL	Slope:
Intercept:
Correlation:
Std. Error Est:
Confidence Interval Slope:
Confidence Interval Intercept:	0.991
0.03
0.9874
0.19
0.948 to 1.034
-0.15 to 0.20
ACE Alera
56 pairs	0.3-6.8 g/dL	Slope:
Intercept:
Correlation:
Std. Error Est:
Confidence Interval Slope:
Confidence Interval. Intercept:	1.002
-0.01
0.9905
0.17
0.964 to 1.040
-0.15 to 0.14
ACE Axcel
56 pairs	0.7-6.7 g/dL	Slope:
Intercept:
Correlation:
Std. Error Est:
Confidence Interval Slope:
Confidence Interval Intercept:	0.956
0.20
0.9850
0.20
0.911 to 1.001
0.04 to 0.37

In-House Matrix Comparison: Serum vs. Plasma – ACE Total Protein Reagent

System	Range	Results - Serum vs. Plasma
ACE	0.5-12.3 g/dL
56 pairs	Slope: 1.001
Intercept: 0.12
Correlation: 0.9798
Std. Error Est: 0.40
Confidence Interval Slope: 0.946 to 1.056
Confidence Interval Intercept: -0.24 to 0.48
ACE Alera	0.5-12.0 g/dL
56 pairs	Slope: 0.999
Intercept: 0.14
Correlation: 0.9840
Std. Error Est: 0.35
Confidence Interval Slope: 0.950 to 1.047
Confidence Interval Intercept: -0.18 to 0.46
ACE Axcel	0.5-13.9 g/dL
81 pairs	Slope: 0.994
Intercept: 0.34
Correlation: 0.9885
Std. Error Est: 0.26
Confidence Interval Slope: 0.961 to 1.028
Confidence Interval Intercept: 0.12 to 0.57

8

Performance Data: In-House

Precision -Serum vs.

Plasma

In-House Matrix Comparison: Serum vs. Plasma – ACE Calcium-Aresnazo Reagent

System	Range	Results - Serum vs. Plasma
ACE
56 pairs	1.0-13.7 mg/dL	Slope: 1.006
Intercept: -0.01
Correlation: 0.9824
Std. Error Est: 0.39
Confidence Interval Slope: 0.955 to 1.058
Confidence Interval Intercept: -0.46 to 0.45
	ACE Alera
56 pairs	1.0-13.7 mg/dL	Slope: 1.008
Intercept: -0.06
Correlation: 0.9793
Std. Error Est: 0.43
Confidence Interval Slope: 0.952 to 1.064
Confidence Interval Intercept: -0.55 to 0.42
		ACE Axcel
81 pairs	0.7-15.0 mg/dL	Slope: 0.978
Intercept: 0.33
Correlation: 0.9911
Std. Error Est: 0.23
Confidence Interval Slope: 0.949 to 1.007
Confidence Interval Intercept: 0.06 to 0.60

In-House Matrix Comparison: Serum vs. Plasma - ACE Inorganic Phosphorus Reagent

System	Range	Results - Serum vs. Plasma
ACE
100 pairs	1.3-19.3 mg/dL	Slope: 1.042
Intercept: -0.26
Correlation: 0.9927
Std. Error Est: 0.33
Confidence Interval Slope: 1.017 to 1.067
Confidence Interval Intercept: -0.38 to -0.14
ACE Alera
102 pairs	1.3-19.3 mg/dL	Slope: 1.049
Intercept: -0.28
Correlation: 0.9928
Std. Error Est: 0.33
Confidence Interval Slope: 1.024 to 1.074
Confidence Interval Intercept: -0.40 to -0.16
ACE Axcel
56 pairs	0.5-19.8 mg/dL	Slope: 0.999
Intercept: 0.04
Correlation: 0.9950
Std. Error Est: 0.34
Confidence Interval Slope: 0.972 to 1.027
Confidence Interval Intercept: -0.12 to 0.20

9

| POL - Precision for ACE and ACE Alera Clinical Chemistry Systems

(Note: Refer to previously cleared submission K113374 for ACE Axcel POL data)
Performance Data:
In-House
Matrix
Comparison –
Serum vs.
Plasma	Albumin
Lab	Sample	Mean	ACE Result
g/dL SD, %CV		Mean	ACE Alera Result
g/dL SD, %CV
				Within-Run	Total	Within-Run	Total
	In-House	1	3.5	0.05
1.4%	0.07
2.0%	3.5	0.02
0.6%	0.04
1.1%
	POL 1	1	3.5	0.04
1.3%	0.04
1.3%	3.5	0.05
1.4%	0.06
1.7%
	POL 2	1	3.5	0.06
1.7%	0.07
2.0%	3.6	0.05
1.4%	0.05
1.5%
	POL 3	1	3.5	0.08
2.3%	0.08
2.4%	3.5	0.05
1.6%	0.05
1.6%
	In-House	2	5.0	0.06
1.2%	0.06
1.2%	5.0	0.05
1.0%	0.05
1.1%
	POL 1	2	4.9	0.06
1.2%	0.07
1.4%	5.0	0.08
1.7%	0.09
1.9%
	POL 2	2	4.9	0.03
0.6%	0.06
1.2%	5.0	0.06
1.2%	0.08
1.6%
	POL 3	2	4.9	0.06
1.2%	0.09
1.9%	4.9	0.03
0.6%	0.03
0.7%
	In-House	3	6.2	0.11
1.9%	0.13
2.1%	6.2	0.06
1.0%	0.07
1.1%
	POL 1	3	6.1	0.07
1.1%	0.07
1.2%	6.2	0.07
1.1%	0.10
1.6%
	POL 2	3	6.1	0.10
1.6%	0.12
1.9%	6.2	0.06
1.0%	0.07
1.1%
	POL 3	3	6.1	0.10
1.7%	0.11
1.8%	6.1	0.08
1.3%	0.08
1.4%

10

				ACE Result			ACE Alera Result
Performance
Data:
In-House
Matrix
Comparison -
Serum vs.
Plasma	Total
Protein	Lab	Sample	Mean	g/dL SD, %CV		Mean	g/dL SD, %CV
					Within-Run	Total		Within-Run	Total
		In-House	1	5.3	0.05	0.06	5.3	0.08	0.10
					0.9%	1.2%		1.5%	1.8%
		POL 1	1	5.3	0.13	0.13	5.5	0.07	0.10
					2.5%	2.5%		1.4%	1.8%
		POL 2	1	5.3	0.08	0.16	5.2	0.07	0.15
					1.5%	3.1%		1.3%	2.8%
		POL 3	1	5.6	0.10	0.12	5.6	0.07	0.12
					1.7%	2.1%		1.4%	2.2%
		In-House	2	8.3	0.10	0.12	8.3	0.10	0.11
					1.2%	1.4%		1.2%	1.4%
		POL 1	2	8.2	0.08	0.11	8.4	0.09	0.10
					1.0%	1.4%		1.1%	1.2%
		POL 2	2	8.3	0.06	0.18	8.4	0.10	0.11
					0.7%	2.1%		1.2%	1.4%
		POL 3	2	8.6	0.04	0.10	8.2	0.09	0.14
					0.5%	1.1%		1.1%	1.7%
		In-House	3	11.2	0.14	0.17	11.3	0.14	0.15
					1.3%	1.5%		1.3%	1.4%
		POL 1	3	11.2	0.14	0.17	11.3	0.14	0.14
					1.3%	1.5%		1.2%	1.2%
		POL 2	3	11.2	0.09	0.20	11.5	0.09	0.16
					0.8%	1.8%		0.8%	1.4%
		POL 3	3	11.4	0.22	0.23	11.1	0.26	0.31
					1.9%	2.0%		2.3%	2.8%

11

				ACE Result			ACE Alera Result
	Calcium-
Arsenazo			mg/dL SD, %CV			mg/dL SD, %CV
	Lab	Sample	Mean	Within-Run	Total	Mean	Within-Run	Total
	In-House	1	7.0	0.12 SD
1.7	0.17 SD
2.4	6.9	0.08 SD
1.2%	0.15 SD
2.1%
	POL 1	1	7.0	0.14 SD
2.0%	0.15 SD
2.1%	6.9	0.07 SD
1.0%	0.19 SD
2.7%
	POL 2	1	7.0	0.16 SD
2.3%	0.17 SD
2.4%	7.0	0.19 SD
2.7%	0.19 SD
2.7%
	POL 3	1	7.0	0.16 SD
2.3%	0.17 SD
2.4%	7.0	0.14 SD
1.9%	0.14 SD
1.9%
	In-House	2	10.7	0.21 SD
2.0%	0.21 SD
2.0%	10.5	0.05 SD
0.5%	0.06 SD
0.6%
	POL 1	2	10.6	0.06 SD
0.6%	0.06 SD
0.6%	10.5	0.09 SD
0.9%	0.33 SD
3.2%
	POL 2	2	10.5	0.12 SD
1.2%	0.15 SD
1.5%	10.6	0.21 SD
1.9%	0.22 SD
2.1%
	POL 3	2	10.5	0.10 SD
1.0%	0.11 SD
1.0%	10.6	0.16 SD
1.5%	0.16 SD
1.5%
	In-House	3	13.6	0.11 SD
0.8%	0.26 SD
1.9%	13.5	0.17 SD
1.3%	0.20 SD
1.5%
	POL 1	3	13.6	0.14 SD
1.1%	0.20 SD
1.5%	13.4	0.14 SD
1.1%	0.34 SD
2.5%
	POL 2	3	13.5	0.32 SD
2.3%	0.37 SD
2.7%	13.6	0.21 SD
1.5%	0.23 SD
1.7%
	POL 3	3	13.6	0.16 SD
1.2%	0.17 SD
1.2%	13.6	0.14 SD
1.0%	0.18 SD
1.3%

・

:

12

| Performance Data:

Precision - POL	POL - Precision for ACE and ACE Alera Clinical Chemistry Systems
Inorganic
Phosphorus
U.V.			ACE Result	ACE Alera Result
Lab	Sample	Mean	mg/dL SD, %CV
Within-Run	mg/dL SD, %CV
Total	Mean	mg/dL SD, %CV
Within-Run	mg/dL SD, %CV
Total
In-House	1	2.7	0.08 SD
3.0%	0.08 SD
3.0%	2.8	0.06 SD
2.1%	0.06 SD
2.1%
POL 1	1	2.7	0.03 SD
1.2%	0.05 SD
1.9%	2.7	0.04 SD
1.4%	0.10 SD
3.8%
POL 2	1	2.6	0.06 SD
2.3%	0.09 SD
3.6%	2.5	0.02 SD
0.9%	0.11 SD
4.4%
POL 3	1	2.8	0.06 SD
2.1%	0.10 SD
3.5%	2.9	0.05 SD
1.9%	0.07 SD
2.4%
In-House	2	7.0	0.07 SD
1.0%	0.09 SD
1.3%	7.1	0.07 SD
0.9%	0.09 SD
1.3%
POL 1	2	7.0	0.04 SD
0.6%	0.07 SD
1.1%	7.1	0.07 SD
0.9%	0.18 SD
2.5%
POL 2	2	6.7	0.08 SD
1.2%	0.14 SD
2.1%	6.7	0.07 SD
1.1%	0.22 SD
3.2%
POL 3	2	7.2	0.04 SD
0.6%	0.07 SD
1.0%	7.4	0.10 SD
1.4%	0.13 SD
1.7%
In-House	3	11.1	0.14 SD
1.2%	0.18 SD
1.6%	11.3	0.09 SD
0.8%	0.11 SD
0.9%
POL 1	3	11.1	0.13 SD
1.2%	0.14 SD
1.3%	11.3	0.16 SD
1.4%	0.27 SD
2.4%
POL 2	3	10.9	0.12 SD
1.1%	0.21 SD
1.9%	10.6	0.15 SD
1.4%	0.21 SD
1.9%
POL 3	3	11.4	0.13 SD
1.1%	0.18 SD
1.6%	11.7	0.11 SD
0.9%	0.14 SD
1.2%

.

13

| Performance
Data:
Precision -

POL	POL – Method Comparison for ACE Clinical Chemistry System
	Reagent	Statistic	ACE In-House (x) vs.
ACE
POL 1 (y)	ACE In-House (x) vs.
ACE
POL 2 (y)	ACE In-House (x) vs.
ACE
POL 3 (y)
	Albumin	n	50	50	50
		Range (g/dL)	1.0 to 6.4	1.0 to 6.4	1.0 to 6.4
		Regression	$y = 0.983x + 0.03$	$y = 0.992x - 0.01$	$y = 1.006x - 0.03$
		Correlation	0.9934	0.9965	0.9971
		Std. Error Est.	0.10	0.08	0.07
		CI Slope	0.950 to 1.016	0.968 to 1.016	0.984 to 1.028
		CI Intercept	-0.11 to 0.17	-0.11 to 0.09	-0.12 to 0.06
	Total Protein	n	51	51	51
		Range (g/dL)	0.9 to 13.6	0.9 to 13.6	0.9 to 13.6
		Regression	$y = 1.008x + 0.02$	$y = 1.007x + 0.06$	$y = 1.029x + 0.01$
		Correlation	0.9957	0.9976	0.9960
		Std. Error Est.	0.15	0.11	0.15
		CI Slope	0.981 to 1.035	0.987 to 1.027	1.003 to 1.056
		CI Intercept	-0.17 to 0.22	-0.08 to 0.20	-0.18 to 0.20
	Calcium-Arsenazo	n	50	50	50
		Range (mg/dL)	1.9 to 13.7	1.9 to 13.7	1.9 to 13.7
		Regression	$y = 1.004x - 0.07$	$y = 1.002x - 0.17$	$y = 0.981x + 0.09$
		Correlation Std.	0.9915	0.9944	0.9951
		Error Est. CI	0.26	0.21	0.19
		Slope	0.966 to 1.042	0.971 to 1.033	0.953 to 1.009
		CI Intercept	-0.42 to 0.27	-0.45 to 0.11	-0.17 to 0.34
	Inorganic
Phosphorus
U.V.	n	50	48	50
		Range (mg/dL)	1.0 to 18.4	1.0 to 18.4	1.0 to 18.4
		Regression	$y = 0.966x + 0.13$	$y = 1.007x - 0.10$	$y = 0.975x + 0.11$
		Correlation Std.	0.9991	0.9982	0.9987
		Error Est. CI	0.12	0.16	0.14
		Slope	0.954 to 0.978	0.989 to 1.025	0.960 to 0.989
		CI Intercept	0.07 to 0.19	-0.18 to -0.01	0.04 to 0.19

14

| Performance

Data:	POL - Method Comparison for ACE Alera Clinical Chemistry System
Precision -
POL	Reagent	Statistic	ACE In-House (x) vs. ACE Alera POL 1 (y)	ACE In-House (x) vs. ACE Alera POL 2 (y)	ACE In-House (x) vs. ACE Alera POL 3 (y)
		n	50	50	50
		Range (g/dL)	1.0 to 6.4	1.0 to 6.4	1.0 to 6.4
		Regression	y= $1.004x - 0.03$	y= $1.005x - 0.05$	y = $0.982x + 0.01$
	Albumin	Correlation	0.9949	0.9960	0.9967
		Std. Error Est.	0.09	0.08	0.07
		CI Slope	0.975 to 1.034	0.979 to 1.031	0.959 to 1.005
		Cl Intercept	-0.15 to 0.10	-0.16 to 0.06	-0.09 to 0.11
		n	51	51	51
		Range (g/dL)	0.9 to 13.6	0.9 to 13.6	0.9 to 13.6
		Regression	y= $0.998x + 0.16$	y = $1.027x - 0.06$	y = $0.979x + 0.24$
	Total Protein	Correlation	0.9969	0.9962	0.9964
		Std. Error Est.	0.13	0.14	0.14
		CI Slope	0.976 to 1.020	1.002 to 1.053	0.955 to 1.003
		CI Intercept	0.00 to 0.33	-0.24 to 0.13	0.07 to 0.42
		n	50	50	50
		Range (mg/dL)	1.9 to 13.7	1.9 to 13.7	1.9 to 13.7
		Regression	y = $0.992x - 0.09$	y = $1.007x - 0.11$	y = $1.008x - 0.08$
	Calcium-
Arsenazo	Correlation Std.	0.9904	0.9929	0.9929
		Error Est. Cl	0.27	0.23	0.23
		Slope	0.952 to 1.032	0.972 to 1.042	0.973 to 1.043
		CI Intercept	-0.46 to 0.27	-0.43 to 0.21	-0.40 to 0.23
		n	50	50	50
		Range (mg/dL)	1.0 to 18.4	1.0 to 18.4	1.0 to 18.4
	Inorganic
Phosphorus
U.V.	Regression	y = $1.015x + 0.14$	y = $0.960x + 0.12$	y = $0.984x + 0.05$
		Correlation Std.	0.9992	0.9986	0.9991
		Error Est. Cl	0.12	0.14	0.12
		Slope	1.003 to 1.027	0.945 to 0.974	0.972 to 0.996
		Cl Intercept	0.08 to 0.20	0.05 to 0.19	-0.01 to 0.11

15

Performance Data:

Method Comparison -POL on ACE

Performance data for the Alfa Wassermann ACE Reagents run on the Alfa Wassermann ACE Alera Clinical Chemistry Systems

Detection Limits - ACE Alera Clinical Chemistry System

| ACE Alera | ALB
(g/dL) | TP
(g/dL) | CA
(mg/dL) | PHOS
(mg/dL) |
|-----------|---------------|--------------|---------------|-----------------|
| LoB | 0.08 | 0.08 | 0.09 | 0.25 |
| LoD | 0.09 | 0.13 | 0.11 | 0.35 |
| LoQ | 0.09 | 0.20 | 0.23 | 0.35 |

Linearity - ACE Alera Clinical Chemistry System

| ACE
Reagents | Low Level
Tested | Upper Level
Tested | Linear to: | Linear Regression
Equation |
|-----------------|---------------------|-----------------------|------------|----------------------------------|
| ALB | 0.1 g/dL | 7.6 g/dL | 7.6 g/dL | y = 0.980x + 0.01
r2 = 0.9982 |
| TP | 0.2 g/dL | 15.1 g/dL | 15.1 g/dL | y=0.991x + 0.04
r2 = 0.9979 |
| CA | 0.3 g/dL | 16.5 mg/dL | 16.5 mg/dL | y=0.992x +0.27
r2 = 0.9990 |
| PHOS | 0.2 mg/dL | 21 mg/dL | 21 mg/dL | y=1.001x +0.03
r2 = 0.9995 |

16

Performance Data:

ACE Alera

Interferences - ACE Alera Clinical Chemistry System

| Interferents

on ACE Alera	No Significant Interference at or below:
	ALB	TP	CA	PHOS
Icterus	60 mg/dL	56.8 mg/dL	58.8 mg/dL	11.5 mg/dL
Hemolysis	250 mg/dL	250 mg/dL	1000 mg/dL	250 mg/dL
Lipemia	1000 mg/dL	929 mg/dL	1000 mg/dL	306 mg/dL
Ascorbic Acid	6 mg/dL	6 mg/dL	6 mg/dL	6 mg/dL

Precision - ACE Alera Clinical Chemistry System

on-ACE Alera		Precision (SD, %CV)
		Mean	Within-Run	Total
ALB
g/dL	Serum Low	2.6	0.03, 1.3%	0.05, 2.0%
	Serum Mid	3.4	0.07, 1.9%	0.09, 2.5%
	Serum High	4.3	0.03, 0.7%	0.10, 2.3%
CA
mg/dL	Serum Low	6.5	0.08, 1.3%	0.13, 2.1%
	Serum Mid	9.8	0.12, 1.2%	0.22, 2.3%
	Serum High	12.6	0.23, 1.8%	0.29, 2.3%
TP
g/dL	Serum Low	4.2	0.10, 2.3%	0.11, 2.6%
	Serum Mid	6.8	0.09, 1.3%	0.14, 2.1%
	Serum High	10.1	0.23, 2.3%	0.32, 3.1%
PHOS
mg/dL	Serum Low	2.0	0.04, 2.3%	0.11, 5.7%
	Serum Mid	3.8	0.12, 3.2%	0.16, 4.2%
	Serum High	6.5	0.17, 2.5%	0.24, 3.6%

17

| Performance
Data:

ACE Alera | Method Comparison - ACE Alera Clinical Chemistry System

In-House ACE (x) versus In-House ACE Alera (y) | | | | |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|-----------------|------------------|-----------------|
| | ALB | TP | CA | PHOS | |
| | n | 50 | 56 | 55 | 55 |
| | Range | 1.0 - 6.4 g/dL | 0.2 - 13.6 g/dL | 0.2 - 13.7 mg/dL | 0.2 -18.4 mg/dL |
| | Slope | 1.005 | 1.009 | 0.991 | 1.006 |
| | Intercept | -0.03 | -0.01 | -0.02 | -0.01 |
| | Correlation
Coefficient | 0.9961 | 0.9988 | 0.9990 | 0.9994 |
| | Std. Error | 0.08 | 0.12 | 0.13 | 0.10 |
| | CI Slope | 0.979 to 1.030 | 0.995 to 1.022 | 0.979 to 1.003 | 0.997 to 1.016 |
| | CI Intercept | -0.13 to 0.08 | -0.10 to 0.08 | -0.13 to 0.08 | -0.06 to 0.03 |
| Conclusions: | Based on the foregoing data, the device is safe and effective for use in clinical laboratories
and physician office laboratories. This data indicates substantial equivalence for lithium
heparin plasma sample collection tubes to the predicate device's use of serum sample
collection tubes. This data also indicates that the ACE Alera Clinical Chemistry System is
substantially equivalent to the predicate device ACE Clinical Chemistry System. | | | | |

18

DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 19, 2013

Alfa Wassermann Diagnostic Technologies, LLC C/O Hyman Katz, Ph.D. 4 Henderson Drive WEST CALDWELL NJ 07006

Re: K131488

Trade/Device Name: ACE Albumin Reagent ACE Total Protein Reagent ACE Calcium-Arsenazo Reagent ACE Inorganic Phosphorus U.V. Reagent Regulation Number: 21 CFR 862.1035 Regulation Name: Albumin test system Regulatory Class: II

Product Code: CIX, CEK, CJY, CEO Dated: July 17, 2013 Received: July 18, 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 to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Ilsting 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 Part 801); 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.

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Page 2-Dr. Katz

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 115800.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Salcty/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the 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.

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

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Indications for Use

510(k) Number (if known): K131488

Device Name: ACE Albumin Reagent

ACE Albumin Reagent is intended for the quantitative determination of Indications for Use: albumin concentration in serum and lithium heparin plasma using the ACE, ACE Alera and ACE Axcel Clinical Chemistry Systems. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
Device Name: ACE Total Protein Reagent
Indications for Use: ACE Total Protein Reagent is intended for the quantitative determination of total protein concentration in serum and lithium heparin plasma using the ACE, ACE Alera and ACE Axcel Clinical Chemistry Systems. Total protein measurements are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
Prescription Use X (21 CFR Part 801 Subpart D)

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)

Ruth A. Chesler -S

Division Sign-Off Office of In Vitro Devices or Radiological Health 510(k) K131488 .

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Indications for Use

510(k) Number (if known): K131488

Device Name: ACE Calcium-Arsenazo Reagent

ACE Calcium-Arsenazo Reagent is intended for the quantitative Indications for Use: determination of calcium concentration in serum and lithium heparin plasma using the ACE, ACE Alera and ACE Axcel Clinical Chemistry Systems. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
Device Name: ACE Inorganic Phosphorus U.V. Reagent
Indications for Use: ACE Inorganic Phosphorus U.V. Reagent is intended for the quantitative determination of inorganic phosphorus concentration in serum and lithium heparin plasma using the ACE, ACE Alera and ACE Axcel Clinical Chemistry Systems. Measurements of inorganic phosphorus are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases and vitamin D imbalance. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
Prescription Use X (21 CFR Part 801 Subpart D)

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)

Ruth A. Chesler -S

Division Sign-Off Office of In Vitro Devices or Radiological Health 510(k) K131488