Predicate Devices

K113253, K931786, K930104, K113436, K113382

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes in vitro diagnostic reagents and the chemical reactions they facilitate for quantitative determination of enzyme activity. There is no mention of AI or ML in the intended use, device description, or performance studies.

Therapeutic

No.
This device is for in vitro diagnostic use, intended for the quantitative determination of certain enzyme activities in serum and plasma, which are used in the diagnosis and treatment of diseases, not for direct therapeutic intervention on a patient.

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 liver, bone, parathyroid, and intestinal diseases," "primarily for the diagnosis and treatment of pancreatitis," and "in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases." This indicates their role in identifying or confirming medical conditions.

SaMD (Software as a Medical Device)

No

The device described is a reagent kit intended for use with specific clinical chemistry systems. It is a chemical product used in laboratory testing, not a software-only medical device.

IVD (In Vitro Diagnostic)

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

Here's why:

Explicit Statement: The "Intended Use / Indications for Use" section for each reagent explicitly states: "For in vitro diagnostic use only."
Intended Use: The reagents are intended for the quantitative determination of specific enzyme activities (alkaline phosphatase, α-amylase, alanine aminotransferase, and aspartate aminotransferase) in human biological samples (serum and lithium heparin plasma).
Clinical Purpose: The measurements are used in the diagnosis and treatment of various diseases (liver, bone, parathyroid, intestinal, pancreatitis, heart).
Intended User/Setting: The tests are intended for use in clinical laboratories and physician office laboratories, which are typical settings for IVD testing.

The device description further supports this by detailing the biochemical reactions used to measure the enzyme activity in the sample, which is the core function of an in vitro diagnostic test.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The ACE Alkaline Phosphatase Reagent is intended for the quantitative determination of alkaline phosphatase activity in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Measurements of alkaline phosphatase are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases. This test is intended for use in clinical laboratories and physician office laboratories. For in vitro diagnostic use only.

The ACE Amylase Reagent is intended for the quantitative determination of α-amylase activity in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas). This test is intended for use in clinical laboratories and physician office laboratories. For in vitro diagnostic use only.

The ACE ALT Reagent is intended for the quantitative determination of alanine aminotransferase activity in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Alanine aminotransferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases. This test is intended for use in clinical laboratories and physician office laboratories. For in vitro diagnostic use only.

The ACE AST Reagent is intended for the quantitative determination of aspartate aminotransferase activity in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Measurements of aspartate aminotransferase are used in the diagnosis and treatment of certain types of liver and heart disease. 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)

CJE, CKA, CIT

Device Description

In the ACE Alkaline Phosphatase Reagent assay, alkaline phosphatase catalyzes the hydrolysis of colorless p-nitrophenyl phosphate to p-nitrophenol and inorganic phosphate. In an alkaline solution (pH 10.5), p-nitrophenol is in the phenoxide form and has a strong absorbance at 408 nm. The rate of increase in absorbance, monitored bichromatically at 408 nm/486 nm, is directly proportional to the alkaline phosphatase activity in the sample.

In the ACE Amylase Reagent assay, α-amylase hydrolyzes the 2-chloro-p-nitrophenyl-α-D-maltotrioside substrate to release 2-chloro-p-nitrophenol and form 2-chloro-p-nitrophenyl-α-D-maltoside, maltotriose and glucose. The rate of increase in absorbance, monitored bichromatically at 408 nm/ 647 nm, is directly proportional to the α-amylase activity in the sample.

In the ACE ALT Reagent assay, alanine aminotransferase converts the L-alanine and α-ketoglutarate substrates in the reagent to L-glutamate and pyruvate, respectively. Lactate dehydrogenase (LDH) catalyzes the oxidation of the reduced cofactor to the cofactor. The rate of conversion of the reduced cofactor to the cofactor can be determined by monitoring the decrease in absorbance bichromatically at 340 nm/647 nm. This rate of conversion from the reduced cofactor to the cofactor is a function of the activity of ALT in the sample.

In the ACE AST Reagent assay, aspartate aminotransferase converts the L-aspartate and α-ketoglutarate in the reagent to oxaloacetate and L-glutamate, respectively. The oxaloacetate undergoes reduction, with concurrent oxidation of NADH to NAD+ in the malate dehydrogenase-catalyzed indicator reaction. NADH absorbs strongly at 340 nm, whereas NAD+ does not. Therefore, the rate of conversion of NADH to NAD+ can be determined by monitoring the decrease in absorbance bichromatically at 340 nm/647 nm. This rate of conversion from NADH to NAD+ is a function of the activity of AST in the sample. Lactate dehydrogenase is added to prevent interference from endogenous pyruvate, which is normally present in blood.

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: In-House
Precision -Serum vs. Plasma
In-House Precision: Serum vs. Plasma – ACE Alkaline Phosphatase Reagent (n=20 for each concentration and system)

ACE System: Mean (U/L) for Serum Low (92), Mid (649), High (1198); Plasma Low (76), Mid (614), High (1163).
Alera System: Mean (U/L) for Serum Low (91), Mid (642), High (1190); Plasma Low (75), Mid (609), High (1149).
Axcel System: Mean (U/L) for Serum Low (90), Mid (645), High (1194); Plasma Low (74), Mid (613), High (1155).
Key results: Provides Within-Run and Total SD and %CV for each concentration level on each system.

In-House Precision: Serum vs. Plasma – ACE Amylase Reagent (n=20 for each concentration and system)

ACE System: Mean (U/L) for Serum Low (46), Mid (830), High (1597); Plasma Low (41), Mid (806), High (1604).
Alera System: Mean (U/L) for Serum Low (46), Mid (825), High (1577); Plasma Low (42), Mid (801), High (1596).
Axcel System: Mean (U/L) for Serum Low (46), Mid (826), High (1586); Plasma Low (41), Mid (805), High (1604).
Key results: Provides Within-Run and Total SD and %CV for each concentration level on each system.

In-House Precision: Serum vs. Plasma – ACE ALT Reagent (n=24 for each concentration and system)

ACE System: Mean (U/L) for Serum Low (36), Mid (114), High (216); Plasma Low (32), Mid (112), High (219).
Alera System: Mean (U/L) for Serum Low (36), Mid (114), High (216); Plasma Low (32), Mid (112), High (219).
Axcel System: Mean (U/L) for Serum Low (37), Mid (115), High (218); Plasma Low (34), Mid (113), High (222).
Key results: Provides Within-Run and Total SD and %CV for each concentration level on each system.

In-House Precision: Serum vs. Plasma – ACE AST Reagent (n=24 for each concentration and system)

ACE System: Mean (U/L) for Serum Low (26), Mid (155), High (301); Plasma Low (26), Mid (157), High (304).
Alera System: Mean (U/L) for Serum Low (25), Mid (155), High (302); Plasma Low (26), Mid (157), High (303).
Axcel System: Mean (U/L) for Serum Low (25), Mid (155), High (304); Plasma Low (26), Mid (158), High (305).
Key results: Provides Within-Run and Total SD and %CV for each concentration level on each system.

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

ACE System (108 pairs): Range 9 - 1274 U/L, Slope 0.998, Intercept -8.3, Correlation 0.9980.
ACE Alera (108 pairs): Range 9 - 1202 U/L, Slope 0.983, Intercept -6.4, Correlation 0.9952.
ACE Axcel (62 pairs): Range 11 - 1222 U/L, Slope 1.017, Intercept -6.5, Correlation 0.9982.

ACE Amylase Reagent:

ACE System (104 pairs): Range 11 - 1766 U/L, Slope 0.977, Intercept 1.7, Correlation 0.9995.
ACE Alera (101 pairs): Range 11 - 1703 U/L, Slope 0.979, Intercept 0.9, Correlation 0.9994.
ACE Axcel (52 pairs): Range 10 - 1890 U/L, Slope 0.994, Intercept -1.76, Correlation 0.9996.

ACE ALT Reagent:

ACE System (54 pairs): Range 4 - 460 U/L, Slope 1.003, Intercept -3.6, Correlation 0.9994.
ACE Alera (52 pairs): Range 5 - 463 U/L, Slope 1.000, Intercept -3.6, Correlation 0.9986.
ACE Axcel (56 pairs): Range 6 - 469 U/L, Slope 0.985, Intercept -3.35, Correlation 0.9993.

Precision - POL
Provides precision data for ACE and ACE Alera Clinical Chemistry Systems for ALP, AMY, ALT, and AST reagents at various laboratories (In-House and POL 1, 2, 3) and sample levels (1, 2, 3). For each, Mean (U/L), Within-Run SD and %CV, and Total SD and %CV are provided.

Method Comparison - POL on ACE
Compares In-House ACE (x) method with POL ACE (y) for ALP, AMY, ALT, and AST reagents.

Sample sizes range from 44 to 51.
Provides Range, Regression Equation (y = mx + b), Correlation, Std. Error Est., CI Slope, and CI Intercept for each comparison.

Method Comparison - POL on ACE Alera
Compares In-House ACE (x) method with POL Alera (y) for ALP, AMY, ALT, and AST reagents.

Sample sizes are listed with some missing/unclear data.
Provides Range, Regression Equation (y = mx + b), Correlation, Std. Error Est., CI Slope, and CI Intercept for each comparison.

Detection Limits - ACE Alera Clinical Chemistry System
LoB, LoD, and LoQ data for ALP, Amylase, ALT, AST on the ACE Alera system.

Linearity - ACE Alera Clinical Chemistry System

ALP: Linear to 1400 U/L, y = 0.998x - 0.5, R^2 = 0.9993.
Amylase: Linear to 1900 U/L, y = 1.013x + 0.2, R^2 = 0.9974.
ALT: Linear to 480 U/L, y = 1.007x - 0.17, R^2 = 0.9992.
AST: Linear to 450 U/L, y = 1.013x + 0.24, R^2 = 0.9992.

Interferences - ACE Alera Clinical Chemistry System
Lists maximum concentrations of Icterus, Hemolysis, Lipemia, and Ascorbic Acid that do not cause interference for ALP, Amylase, ALT, AST.

Precision - ACE Alera Clinical Chemistry System
Provides Mean, Within-Run SD and %CV, and Total SD and %CV for ALP, Amylase, ALT, AST at Low, Mid, and High levels on ACE Alera.

Method Comparison - ACE Alera Clinical Chemistry System
In-House ACE (x) vs. In-House ACE Alera (y)

ALP: n=60, Range 9 to 1199 U/L, Slope 0.991, Intercept 0.5, Correlation 0.9999, Std. Error 3.5.
Amylase: n=57, Range 10 to 1732 U/L, Slope 0.995, Intercept 2.9, Correlation 0.9998, Std. Error 6.6.
ALT: n=50, Range 6 to 442 U/L, Slope 0.988, Intercept 1.3, Correlation 0.9999, Std. Error 1.6.
AST: n=50, Range 6 to 413 U/L, Slope 1.006, Intercept 1.5, Correlation 0.9998, Std. Error 1.9.

Conclusions: Based on the foregoing data, the device is safe and effective for use in clinical laboratories and physician office laboratories. These data indicate substantial equivalence for lithium heparin plasma sample collection tubes to the predicate device's use of serum sample collection tubes.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Key metrics provided are Mean (U/L), Within-Run SD, Within-Run %CV, Total SD, Total %CV for precision, and Slope, Intercept, and Correlation Coefficient for method comparison. LoB, LoD, LoQ, and R^2 values are provided for linearity.

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K113253, K931786, K930104, K113436, K113382

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 862.1050 Alkaline phosphatase or isoenzymes test system.

(a)
Identification. An alkaline phosphatase or isoenzymes test system is a device intended to measure alkaline phosphatase or its isoenzymes (a group of enzymes with similar biological activity) in serum or plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.(b)
Classification. Class II.

Summary

0

131351

510(k) SUMMARY

| 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 5 2013 |
| Date Summary
Prepared: | July 3, 2013 | |
| Device: | Trade Name: | ACE Alkaline Phosphatase Reagent |
| | Classification: | Class 2 |
| | Common/Classification Name: | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
(21 C. F.R. § 862.1050)
Product Code CJE |
| | Trade Name: | ACE Amylase Reagent |
| | Classification: | Class 2 |
| | Common/Classification Name: | Saccharogenic, Amylase
(21 C. F.R. § 862.1070)
Product Code CIJ |
| | Trade Name: | ACE ALT Reagent |
| | Classification: | Class 1 |
| | Common/Classification Name: | NADH Oxidation/NAD Reduction, ALT/SGPT
(21 C.F.R. § 862.1030)
Product Code CKA |
| | Trade Name: | ACE AST Reagent |
| | Classification: | Class 2 |
| | Common/Classification Name: | NADH Oxidation/NAD Reduction, AST/SGOT
(21 C.F.R. § 862.1100)
Product Code CIT |
| Predicate
Devices: | Manufacturer for reagent system predicates:
Alfa Wassermann ACE and ACE Axcel Clinical Chemistry Systems and ACE
Reagents (K113253, K931786, K930104, K113436, K113382) | |
| Device Descriptions: | In the ACE Alkaline Phosphatase Reagent assay, alkaline phosphatase catalyzes the
hydrolysis of colorless p-nitrophenyl phosphate to p-nitrophenol and inorganic
phosphate. In an alkaline solution (pH 10.5), p-nitrophenol is in the phenoxide form
and has a strong absorbance at 408 nm. The rate of increase in absorbance, monitored
bichromatically at 408 nm/486 nm, is directly proportional to the alkaline phosphatase
activity in the sample.

In the ACE Amylase Reagent assay, α-amylase hydrolyzes the 2-chloro-p-nitrophenyl-
α-D-maltotrioside substrate to release 2-chloro-p-nitrophenol and form 2-chloro-p-
nitrophenyl-α-D-maltoside, maltotriose and glucose. The rate of increase in
absorbance, monitored bichromatically at 408 nm/ 647 nm, is directly proportional to
the α-amylase activity in the sample.

In the ACE ALT Reagent assay, alanine aminotransferase converts the L-alanine and α-
ketoglutarate substrates in the reagent to L-glutamate and pyruvate, respectively.
Lactate dehydrogenase (LDH) catalyzes the oxidation of the reduced cofactor to the
cofactor. The rate of conversion of the reduced cofactor to the cofactor can be
determined by monitoring the decrease in absorbance bichromatically at 340 nm/647
nm. This rate of conversion from the reduced cofactor to the cofactor is a function of
the activity of ALT in the sample.

In the ACE AST Reagent assay, aspartate aminotransferase converts the L-aspartate
and α-ketoglutarate in the reagent to oxaloacetate and L-glutamate, respectively. The
oxaloacetate undergoes reduction, with concurrent oxidation of NADH to NAD+ in the malate dehydrogenase-catalyzed indicator reaction. NADH absorbs strongly at 340 nm,
whereas NAD+ does not. Therefore, the rate of conversion of NADH to NAD+ can be
determined by monitoring the decrease in absorbance bichromatically at 340 nm/647
nm. This rate of conversion from NADH to NAD+ is a function of the activity of AST
in the sample. Lactate dehydrogenase is added to prevent interference from endogenous
pyruvate, which is normally present in blood. | |
| Intended Use: | Indications for Use:
The ACE Alkaline Phosphatase Reagent is intended for the quantitative determination
of alkaline phosphatase activity in serum and lithium heparin plasma using the ACE,
ACE Alera, and ACE Axcel Clinical Chemistry Systems. Measurements of alkaline
phosphatase are used in the diagnosis and treatment of liver, bone, parathyroid, and
intestinal diseases. This test is intended for use in clinical laboratories and physician
office laboratories. For in vitro diagnostic use only.

The ACE Amylase Reagent is intended for the quantitative determination of α-amylase
activity in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE
Axcel Clinical Chemistry Systems. Amylase measurements are used primarily for the
diagnosis and treatment of pancreatitis (inflammation of the pancreas). This test is
intended for use in clinical laboratories and physician office laboratories. For in vitro
diagnostic use only. | |
| | | |
| Intended Use: | The ACE ALT Reagent is intended for the quantitative determination of alanine
aminotransferase activity in serum and lithium heparin plasma using the ACE, ACE
Alera, and ACE Axcel Clinical Chemistry Systems. Alanine aminotransferase
measurements are used in the diagnosis and treatment of certain liver diseases (e.g.,
viral hepatitis and cirrhosis) and heart diseases. This test is intended for use in clinical
laboratories and physician office laboratories. For in vitro diagnostic use only. | |
| | The ACE AST Reagent is intended for the quantitative determination of aspartate
aminotransferase activity in serum and lithium heparin plasma using the ACE, ACE
Alera, and ACE Axcel Clinical Chemistry Systems. Measurements of aspartate
aminotransferase are used in the diagnosis and treatment of certain types of liver and
heart disease. This test is intended for use in clinical laboratories and physician office
laboratories. For in vitro diagnostic use only. | |
| Technological
Characteristics: | The ACE Alkaline Phosphatase Reagent is composed of two reagent bottles (Buffer
and Substrate Reagent). The reagents contain AMP Buffer (pH 10.45), magnesium
acetate, and p-nitrophenyl phosphate. | |
| | The ACE Amylase Reagent is composed of a single reagent bottle. The reagents
contain 2-chloro-p-nitrophenyl-a-D-maltotrioside, sodium chloride, calcium acetate,
potassium thiocyanate, and MES buffer (pH 6.0). | |
| | The ACE ALT Reagent consists of two reagent bottles (Substrate and Coenzyme). The
reagents contain L-alanine, α-ketoglutarate, nicotinamide adenine dinucleotide-reduced
(NADH), lactate dehydrogenase, and Tris buffer. | |
| | The ACE AST Reagent consists of two reagent bottles (Substrate and Coenzyme). The
reagents contain L-aspartate, α-ketoglutarate, nicotinamide adenine dinucleotide-
reduced (NADH), malate dehydrogenase, lactate dehydrogenase, and Tris buffer. | |

·

1

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:

2

3

	Comparison of similarities and differences with predicate device
Device Comparison with Predicate	ACE Alkaline Phosphatase Reagent
ALP	Candidate Device	Predicate Device K931786 (ACE ALP)
Intended Use/ Indications for Use	The ACE Alkaline Phosphatase Reagent is intended for the quantitative determination of alkaline phosphatase activity.	Same
Platforms	ACE, ACE Alera®, and ACE Axcel Clinical Chemistry Systems	ACE Clinical Chemistry System
Method	Photometric	Same
Calibration Stability	Not a calibrated test	Same
On-Board Stability	SA2002: 20 Days
RX2002: 7 Days	Same
Sample Type	Serum and lithium heparin plasma	Serum
Sample Volume	4 µL	Same
Reaction Volume	169 µL	Same
Expected Values	44 - 147 U/L	Same
Measuring Range	9 - 1400 U/L	Same
Sample Stability	Serum ALP is stable for 7 days at 4-8°C and for 2 months at -20°C	Same
	ACE Amylase Reagent
AMYLASE	Candidate Device	Predicate Device K931786 (ACE Amylase)
Intended Use/ Indications for Use	The ACE Amylase Reagent is intended for the quantitative determination of α-amylase activity.	Same
Platforms	ACE, ACE Alera®, and ACE Axcel Clinical Chemistry Systems	ACE Clinical Chemistry System
Method	Photometric	Same
Calibration Stability	Not a calibrated test	Same
On-Board Stability	30 Days	Same
Sample Type	Serum and lithium heparin plasma	Serum
Sample Volume	3 µL	Same
Reaction Volume	168 µL	Same
Expected Values	20 - 104 U/L	Same
Measuring Range	9 - 1900 U/L	Same
	ACE ALT Reagent
ALT	Candidate Device	Predicate Device
K930104
(ACE ALT)
Intended Use/
Indications for Use	The ACE ALT Reagent is intended for the
quantitative determination of alanine
aminotransferase activity concentration.	Same
Platforms	ACE, ACE Alera®, and ACE Axcel Clinical
Chemistry Systems	ACE Clinical
Chemistry System
Method	Photometric	Same
Calibration Stability	Not a calibrated test	Same
On-Board Stability	30 Days	Same
Sample Type	Serum and lithium heparin plasma	Serum
Sample Volume	13 µL	Same
Reaction Volume	185 µL	Same
Expected Values	5 - 30 U/L	Same
Measuring Range	4 - 480 U/L	Same
Sample Stability	Specimen is stable for 7 days at 4-8°C and -20°C.	Same
	ACE AST Reagent
AST	Candidate Device	Predicate Device
K930104
(ACE AST)
Intended Use/
Indications for Use	The ACE AST Reagent is intended for the
quantitative determination of aspartate
aminotransferase activity.	Same
Platforms	ACE, ACE Alera®, and ACE Axcel Clinical
Chemistry Systems	ACE Clinical
Chemistry System
Method	Photometric	Same
Calibration Stability	Not a calibrated test	Same
On-Board Stability	30 Days	Same
Sample Type	Serum and lithium heparin plasma	Serum
Sample Volume	13 µL	Same
Reaction Volume	185 µL	Same
Expected Values	7 - 31 U/L	Same
Measuring Range	4 - 450 U/L	Same

and the comments of the comments of the comments of the comments of

4

.

5

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 Precision: Serum vs. Plasma – ACE Alkaline Phosphatase Reagent

Precision (SD, %CV)
ALP
(n=20)	ACE		Alera	Axcel
	Mean
(U/L)	Within-
Run	Total	Mean
(U/L)	Within-
Run	Total	Mean
(U/L)	Within-
Run	Total
Serum
Low	92	1.2,
1.3%	1.9,
2.0%	91	0.8,
0.9%	2.0,
2.2%	90	1.2,
1.3%	2.1,
2.3%
Serum
Mid	649	6.3,
1.0%	8.6,
1.3%	642	6.4,
1.0%	6.4,
1.0%	645	6.8,
1.0%	6.9,
1.1%
Serum
High	1198	20.2,
1.7%	20.8,
1.7%	1190	5.6,
0.5%	8.7,
0.7%	1194	6.1,
0.5%	7.9,
0.7%
Plasma
Low	76	1.9,
2.5%	2.8,
3.7%	75	0.8,
1.1%	3.4,
4.6%	74	1.1,
1.5%	3.7,
5.1%
Plasma
Mid	614	5.8,
0.9%	24.4,
4.0%	609	5.1,
0.8%	20.2,
3.3%	613	3.4,
0.6%	20.5,
3.3%
Plasma
High	1163	6.8,
0.6%	33.5,
2.9%	1149	5.9,
0.5%	32.9,
2.9%	1155	7.6,
0.7%	35.7,
3.1%

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

			Precision (SD, %CV)
AMY
(n=20)	Mean
(U/L)	Within-Run	Total	Mean
(U/L)	Within-Run	Total	Mean
(U/L)	Within-Run	Total
	ACE			Alera	Axcel
Serum
Low	46	0.7,
1.5%	0.9,
2.1%	46	1.0,
2.1%	1.5,
3.3%	46	1.2,
2.6%	1.6,
3.4%
Serum
Mid	830	9.2,
1.1%	11.5,
1.4%	825	5.1,
0.6%	11.9,
1.4%	826	9.2,
1.1%	11.9,
1.4%
Serum
High	1597	15.0,
0.9%	19.8,
1.2%	1577	9.9,
0.6%	29.4,
1.9%	1586	8.5,
0.5%	18.6,
1.2%
Plasma
Low	41	0.7,
1.8%	1.3,
3.2%	42	0.5,
1.3%	1.5,
3.5%	41	1.0,
2.5%	2.5,
6.0%
Plasma
Mid	806	8.1,
1.0%	12.5,
1.5%	801	4.4,
0.5%	13.1,
1.6%	805	5.3,
0.7%	12.2,
1.5%
Plasma
High	1604	15.4,
1.0%	29.3,
1.8%	1596	18.8,
1.2%	33.8,
2.1%	1604	21.6,
1.3%	25.0,
1.6%

6

| Performance Data:
In-House
Precision –
Serum vs.

Plasma	In-House Precision: Serum vs. Plasma – ACE ALT Reagent	Precision (SD, %CV)
	ALT
(n=24)	Mean
(U/L)	ACE
Within-Run	Total	Mean
(U/L)	Alera
Within-Run	Total	Mean
(U/L)	Axcel
Within-Run	Total
	Serum Low	36	0.9,
2.6%	1.4,
4.0%	36	0.6,
1.7%	1.2,
3.3%	37	1.1,
3.1%	1.4,
3.7%
	Serum Mid	114	1.3,
1.2%	1.8,
1.6%	114	1.3,
1.1%	2.2,
2.0%	115	1.4,
1.2%	2.3,
2.0%
	Serum High	216	2.9,
1.4%	4.0,
1.9%	216	1.8,
0.8%	3.5,
1.6%	218	1.4,
0.6%	3.2,
1.5%
	Plasma Low	32	0.9,
2.7%	1.3,
4.0%	32	0.8,
2.6%	1.5,
4.7%	34	1.0,
2.9%	1.4,
4.1%
	Plasma Mid	112	1.1,
1.0%	1.5,
1.4%	112	0.9,
0.8%	1.1,
1.0%	113	1.0,
0.9%	1.5,
1.4%
	Plasma High	219	1.1,
0.5%	1.6,
0.7%	219	2.1,
0.9%	3.0,
1.4%	222	1.7,
0.7%	2.7,
1.2%

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

Precision (SD, %CV)
AST
(n=24)	Mean
(U/L)	ACE
Within-Run	Total	Mean
(U/L)	Alera
Within-Run	Total	Mean
(U/L)	Axcel
Within-Run	Total
Serum
Low	26	0.7,
2.6%	1.2,
4.5%	25	0.7,
2.7%	0.8,
3.3%	25	1.1,
4.3%	1.4,
5.7%
Serum
Mid	155	1.3,
0.8%	2.7,
1.8%	155	1.0,
0.7%	2.8,
1.8%	155	0.7,
0.5%	2.3,
1.5%
Serum
High	301	3.5,
1.2%	4.8,
1.6%	302	2.2,
0.7%	4.0,
1.3%	304	2.7,
0.9%	4.1,
1.4%
Plasma
Low	26	0.8,
3.2%	1.4,
5.4%	26	0.6,
2.5%	1.0,
3.7%	26	0.9,
3.5%	1.0,
4.0%
Plasma
Mid	157	1.6,
1.0%	2.3,
1.4%	157	1.5,
0.9%	1.7,
1.1%	158	1.4,
0.9%	2.0,
1.3%
Plasma
High	304	3.5,
1.2%	4.5,
1.5%	303	2.6,
0.9%	3.9,
1.3%	305	3.2,
1.1%	4.3,
1.4%

7

| Performance Data:
In-House Matrix
Comparison –
Serum vs.
Plasma | Performance data for the Alfa Wassermann ACE Reagents run on the Alfa Wassermann ACE, ACE Alera and ACE Axcel Clinical Chemistry System
In-House Matrix Comparison: Serum vs. Plasma – ACE ALP Reagent | | | |
|-----------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|-------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|
| | System | Range | Results – Serum vs. Plasma | |
| | ACE
108 pairs | 9 - 1274 U/L | Slope:
Intercept:
Correlation:
Std. Error Est:
Confidence Interval Slope:
Confidence Interval Intercept: | 0.998
-8.3
0.9980
13.5
0.986 to 1.010
-11.5 to -5.1 |
| | ACE Alera
108 pairs | 9 - 1202 U/L | Slope:
Intercept:
Correlation:
Std. Error Est:
Confidence Interval Slope:
Confidence Interval Intercept: | 0.983
-6.4
0.9952
20.2
0.965 to 1.002
-11.2 to -1.6 |
| | ACE Axcel
62 pairs | 11 - 1222 U/L | Slope:
Intercept:
Correlation:
Std. Error Est:
Confidence Interval Slope:
Confidence Interval Intercept: | 1.017
-6.5
0.9982
14.5
1.001 to 1.033
-11.1 to -1.8 |
| | In-House Matrix Comparison: Serum vs. Plasma – ACE Amylase Reagent | | | |
| | System | Range | Results – Serum vs. Plasma | |
| | ACE
104 pairs | 11 - 1766 U/L | Slope:
Intercept:
Correlation:
Std. Error Est:
Confidence Interval Slope:
Confidence Interval Intercept: | 0.977
1.7
0.9995
8.8
0.970 to 0.983
-0.2 to 3.6 |
| | ACE Alera
101 pairs | 11 - 1703 U/L | Slope:
Intercept:
Correlation:
Std. Error Est:
Confidence Interval Slope:
Confidence Interval Intercept: | 0.979
0.9
0.9994
9.0
0.972 to 0.986
-1.0 to 2.9 |
| | ACE Axcel
52 pairs | 10 - 1890 U/L | Slope:
Intercept:
Correlation:
Std. Error Est:
Confidence Interval Slope:
Confidence Interval Intercept: | 0.994
-1.76
0.9996
11.54
0.986 to 1.002
5.33 to 1.80 |

8

In-House Matrix Comparison: Serum vs. Plasma – ACE ALT Reagent
Performance Data:	System	Range	Results - Serum vs. Plasma
In-House Matrix Comparison – Serum vs. Plasma	ACE
54 pairs	4 - 460 U/L	Slope: 1.003
Intercept: -3.6
Correlation: 0.9994
Std. Error Est: 2.8
Confidence Interval Slope: 0.994 to 1.013
Confidence Interval Intercept: -4.5 to -2.8
	ACE Alera
52 pairs	5 - 463 U/L	Slope: 1.000
Intercept: -3.6
Correlation: 0.9986
Std. Error Est: 4.3
Confidence Interval Slope: 0.985 to 1.015
Confidence Interval Intercept: -4.9 to -2.2
	ACE Axcel
56 pairs	6 - 469 U/L	Slope: 0.985
Intercept: -3.35
Correlation: 0.9993
Std. Error Est: 2.94
Confidence Interval Slope: 0.976 to 0.995
Confidence Interval Intercept: -4.24 to -2.47

9

| Performance Data:
Precision - POL | POL - Precision for ACE and ACE Alera Clinical Chemistry Systems
(Note: Please refer to previously cleared submissions K113436 (ALP and Amylase) and
K113382 (ALT and AST) for ACE Axcel POL data) | | | | | | | | Performance
Data at POL:
Precision -
POL | POL - Precision for ACE and ACE Alera Clinical Chemistry Systems | | | | | | | ALT | | | ACE Results
U/L SD, %CV | | | ACE Alera Results
U/L SD, %CV | | | | AST | | | ACE Results
U/L SD, %CV | | | ACE Alera Results
U/L SD, %CV | | |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|------|--------------|--------------|------|-------------------|--------------|---------------------------------------------------|------------------------------------------------------------------|---|------|----------------------------|--------------|------|----------------------------------|--------------|----------|--------|----------------------------|----------------|--------------|----------------------------------|----------------|-------------|----------|--------|------|-------------|----------------------------|------|-------------|----------------------------------|--|--|
| | | | | ACE Results | | | ACE Alera Results | | | | | | ACE Results
U/L SD, %CV | | | ACE Alera Results
U/L SD, %CV | | Lab | Sample | Mean | Within-
Run | Total | Mean | Within-
Run | Total | Lab | Sample | Mean | Within-Run | Total | Mean | Within-Run | Total | | |
| | | ALP | | | U/L SD, %CV | Mean | U/L SD, %CV | | | AMY | | Mean | Within-
Run | Total | Mean | Within-
Run | Total | In-House | 1 | 33 | 0.9
2.7% | 1.3
3.9% | 32 | 1.1
3.5% | 1.2
3.9% | In-House | 1 | 28 | 1.4
5.1% | 2.1
7.4% | 28 | 1.2
4.5% | 1.7
6.0% | | |
| | Lab | Sample | Mean | Within-Run | Total | | Within-Run | Total | | In-House | 1 | 39 | 1.0
2.7% | 1.3
3.2% | 39 | 0.8
2.1% | 1.4
3.5% | POL 1 | 1 | 26 | 0.5
1.9% | 1.7
6.4% | 28 | 1.4
5.1% | 2.4
8.4% | POL 1 | 1 | 23 | 0.9
3.7% | 1.4
6.0% | 26 | 1.0
3.8% | 1.3
5.1% | | |
| | In-House | 1 | 59 | 1.2
2.0% | 1.4
2.5% | 60 | 1.1
1.8% | 1.3
2.1% | | POL 1 | 1 | 37 | 0.5
1.5% | 1.2
3.2% | 38 | 0.9
2.4% | 1.7
4.4% | POL 2 | 1 | 27 | 0.9
3.2% | 1.8
6.7% | 26 | 0.9
3.6% | 2.1
8.2% | POL 2 | 1 | 28 | 1.5
5.6% | 1.7
6.0% | 27 | 2.0
7.5% | 2.4
8.9% | | |
| | POL 1 | 1 | 55 | 0.7
1.4% | 2.3
4.1% | 56 | 0.8
1.4% | 1.7
3.0% | | POL 2 | 1 | 39 | 0.7
1.9% | 0.9
2.4% | 40 | 1.3
3.2% | 1.3
3.2% | POL 3 | 1 | 30 | 1.0
3.4% | 1.7
5.7% | 29 | 2.1
7.5% | 2.4
8.4% | POL 3 | 1 | 26 | 0.7
2.7% | 2.0
7.7% | 29 | 2.9
9.9% | 2.9
9.9% | | |
| | POL 2 | 1 | 54 | 0.9
1.6% | 1.6
2.9% | 59 | 1.2
2.0% | 2.1
3.5% | | POL 3 | 1 | 39 | 0.6
1.6% | 1.1
2.7% | 39 | 1.0
2.5% | 1.1
2.8% | In-House | 2 | 191 | 4.8
2.5% | 4.8
2.5% | 190 | 4.0
2.1% | 4.1
2.1% | In-House | 2 | 223 | 6.4
2.9% | 6.6
3.0% | 222 | 4.8
2.2% | 7.1
3.2% | | |
| | POL 3 | 1 | 57 | 1.0
1.8% | 1.5
2.6% | 56 | 1.4
2.5% | 3.0
5.4% | | In-House | 2 | 741 | 7.1
1.0% | 8.6
1.2% | 747 | 4.4
0.6% | 7.3
1.0% | POL 1 | 2 | 189 | 1.2
0.6% | 1.6
0.8% | 193 | 1.7
0.9% | 2.0
1.0% | POL 1 | 2 | 220 | 2.2
1.0% | 4.0
1.8% | 220 | 2.0
0.9% | 3.2
1.5% | | |
| | In-House | 2 | 648 | 5.5
0.8% | 6.7
1.0% | 653 | 4.5
0.7% | 7.0
1.1% | | POL 1 | 2 | 725 | 4.6
0.6% | 11.5
1.6% | 723 | 4.7
0.6% | 7.0
1.0% | POL 2 | 2 | 192 | 2.3
1.2% | 5.9
3.1% | 194 | 2.2
1.1% | 2.5
1.3% | POL 2 | 2 | 227 | 2.0
0.9% | 4.8
2.1% | 233 | 3.8
1.6% | 5.0
2.1% | | |
| | POL 1 | 2 | 632 | 6.9
1.1% | 13.4
2.1% | 626 | 7.4
1.2% | 16.7
2.7% | | POL 2 | 2 | 727 | 7.4
1.0% | 8.2
1.1% | 770 | 4.3
0.6% | 6.1
0.8% | POL 3 | 2 | 188 | 2.9
1.5% | 3.9
2.1% | 195 | 3.5
1.8% | 5.0
2.6% | POL 3 | 2 | 223 | 2.6
1.2% | 4.7
2.1% | 229 | 5.3
2.3% | 7.2
3.2% | | |
| | POL 2 | 2 | 631 | 6.2
1.0% | 11.9
1.9% | 659 | 4.2
0.6% | 18.0
2.7% | | POL 3 | 2 | 737 | 9.6
1.3% | 11.3
1.5% | 747 | 5.8
0.8% | 7.4
1.0% | In-House | 3 | 309 | 2.2
0.7% | 3.7
1.2% | 307 | 4.0
1.3% | 4.1
1.3% | In-House | 3 | 410 | 6.3
1.5% | 6.8
1.7% | 406 | 2.9
0.7% | 6.8
1.7% | | |
| | POL 3 | 2 | 642 | 3.7
0.6% | 8.6
1.3% | 640 | 5.9
0.9% | 21.9
3.4% | | In-House | 3 | 1429 | 7.5
0.5% | 13.1
0.9% | 1437 | 11.6
0.8% | 12.8
0.9% | POL 1 | 3 | 304 | 4.0
1.3% | 4.4
1.4% | 309 | 3.1
1.0% | 3.6
1.2% | POL I | 3 | 416 | 5.0
1.2% | 5.5
1.3% | 416 | 7.8
1.9% | 9.2
2.2% | | |
| | In-House | 3 | 1191 | 7.0
0.6% | 10.7
0.9% | 1192 | 9.4
0.8% | 13.4
1.1% | | POL 1 | 3 | 1389 | 18.1
1.3% | 27.8
2.0% | 1388 | 19.5
1.4% | 21.6
1.6% | POL 2 | 3 | 311 | 2.9
0.9% | 10.2
3.3% | 314 | 2.3
0.7% | 2.6
0.8% | POL 2 | 3 | 420 | 9.0
2.2% | 10.2
2.4% | 428 | 5.1
1.2% | 5.6
1.3% | | |
| | POL 1 | 3 | 1145 | 10.3
0.9% | 23.0
2.0% | 1135 | 19.0
1.7% | 25.0
2.2% | | POL 2 | 3 | 1401 | 22.4
1.6% | 23.8
1.7% | 1500 | 10.3
0.7% | 11.7
0.8% | POL 3 | 3 | 303 | 3.4
1.1% | 5.0
1.6% | 310 | 8.5
2.8% | 9.1
3.0% | POL 3 | 3 | 407 | 3.9
0.9% | 7.3
1.8% | 417 | 8.2
2.0% | 12.1
2.9% | | |
| | POL 2 | 3 | 1159 | 12.8
1.1% | 17.2
1.5% | 1209 | 9.6
0.8% | 29.3
2.4% | | POL 3 | 3 | 1410 | 12.9
0.9% | 15.7
1.1% | 1435 | 8.4
0.6% | 14.4
1.0% | | | | | | | | | | | | | | | | | | |
| | POL 3 | 3 | 1185 | 6.2
0.5% | 7.3
0.6% | 1165 | 6.6
0.6% | 37.2
3.2% | | | | | | | | | | | | | | | | | | | | | | | | | | | |

10

11

12

13

| Performance Data:
Method
Comparison -
POL on ACE | Reagent | Statistic | In-House ACE vs.
POL 1 ACE (y) | In-House ACE (x)
vs.
POL 2 ACE (y) | In-House ACE(x)
vs.
POL 3 ACE (y) |
|-----------------------------------------------------------| | | | | | | | | | | | | | | | | | | | | | | | | | | | | (x)
---------|-----------------|------------------------------------------|------------------------------------------|-----------------------------------------|
| ALP | n | 49 | 50 | 50 |
| | Range | 58 to 1199 | 58 to 1199 | 58 to 1199 |
| | Regression | $y = 0.989x - 9.5$ | $y = 0.977x - 7.9$ | $y = 0.982x - 2.8$ |
| | Correlation | 0.9987 | 0.9997 | 0.9995 |
| | Std. Error Est. | 12.4 | 5.9 | 7.4 |
| | CI Slope | 0.975 to 1.004 | 0.970 to 0.984 | 0.973 to 0.990 |
| | CI Intercept | -13.8 to -5.1 | -9.9 to -5.8 | -5.4 to -0.2 |
| AMY | n | 51 | 51 | 51 |
| | Range | 28 to 1732 | 28 to 1732 | 28 to 1732 |
| | Regression | $y = 0.970x + 1.5$ | $y = 0.973x + 3.6$ | $y = 0.974x + 3.9$ |
| | Correlation | 0.9995 | 0.9998 | 0.9998 |
| | Std. Error Est. | 11.1 | 7.5 | 7.4 |
| | CI Slope | 0.962 to 0.979 | 0.967 to 0.978 | 0.968 to 0.980 |
| | CI Intercept | -2.1 to 5.2 | 1.1 to 6.0 | 1.5 to 6.3 |
| ALT | n | 44 | 47 | 49 |
| | Range | 6 to 442 | 6 to 442 | 6 to 442 |
| | Regression | $y = 1.006x - 4.7$ | $y = 1.021x - 4.0$ | $y = 0.982x - 2.3$ |
| | Correlation | 0.9978 | 0.9993 | 0.9981 |
| | Std. Error Est. | 6.5 | 3.7 | 5.7 |
| | CI Slope | 0.985 to 1.026 | 1.010 to 1.033 | 0.964 to 0.999 |
| | CI Intercept | -6.9 to -2.4 | -5.2 to -2.8 | -4.1 to -0.4 |
| AST | n | 50 | 50 | 50 |
| | Range | 6 to 413 | 6 to 413 | 6 to 413 |
| | Regression | $y = 0.999x - 0.6$ | $y = 1.019x + 2.4$ | $y = 0.992x + 0.6$ |
| | Correlation | 0.9993 | 0.9989 | 0.9994 |
| | Std. Error Est. | 3.9 | 4.9 | 3.6 |
| | CI Slope | 0.988 to 1.010 | 1.005 to 1.033 | 0.982 to 1.003 |
| | CI Intercept | -1.9 to 0.6 | 0.9 to 4.0 | -0.6 to 1.7 |

14

| Performance

Data at POL:	POL - Method Comparison for ACE Alera Clinical Chemistry System
Method
Comparison -			In-House ACE (x)	In-House ACE (x)	In-House ACE (x)
POL on ACE
Alera	Reagent	Statistic	vs.
POL 1 Alera (y)	vs.
POL 2 Alera (y)	vs.
POL 3 Alera (y)
			રા	રેી	રેપ
		n
Range	58 to 1199	58 to 1199	58 to 1199
		Regression	y = 0.997x - 4.6	y = 1.029x - 4.1	y = 1.010x - 6.6
		Correlation	0.9992	0.9991	0.9986
	ALP		10.1	10.8	13.0
		Std. Error Est.			0.995 to 1.025
		CI Slope	0.985 to 1.008	1.016 to 1.041	-11.2 to -2.1
		CI Intercept	-8.1 to -1.1
રે I	-7.9 to -0.4
રે ।	ર I
		n	28 to 1732	28 to 1732	28 to 1732
		Range		y = 1.010x + 5.8	y = 0.990x + 3.7
		Regression
Correlation	y = 0.960x + 3.0
0.9991	0.9995	0.9995
	AMY	Std. Error Est.	15.1	11.7	11.3
		CI Slope	0.948 to 0.971	1.001 to 1.018	0.981 to 0.999
		CI Intercept	-1.9 to 7.9	2.0 to 9.6	0.0 to 7.4
		n	રે રેપ	48	રે0
		Range	6 to 442	6 to 442	6 to 442
		Regression	y = 1.019x - 0.5	y = 1.012x - 3.5	y = 0.970x + 2.4
	ALT	Correlation	0.9986	0.9985	0.9977
		Std. Error Est.	રું I	5.3	6.1
		CI Slope	1.003 to 1.035	0.995 to 1.028	0.951 to 0.990
		Cl Intercept	-2.1 to 1.1	-5.3 to -1.8	0.5 to 4.4
		n	રેપ	ર૦	રે)
		Range	6 to 413	6 to 413	6 to 413
		Regression	y = 1.028x + 1.4	y = 1.040x + 0.5	y = 1.004x + 1.8
	AST	Correlation	0.9995	0.9992	0.9995
		Std. Error Est.	3.5	4.3	3.3
		CI Slope	1.018 to 1.037	1.027 to 1.052	0.994 to 1.013
		CI Intercept	0.3 to 2.5	-0.8 to 1.9	0.8 to 2.9

15

Performance Data: Performance data for the Alfa Wassermann ACE Reagents run on the ACE Alera Alfa Wassermann ACE Alera Clinical Chemistry Systems Detection Limits - ACE Alera Clinical Chemistry System ACE Alera ALP Amylase ALT AST LoB (U/L) 2.8 0.2 1.6 2.2 : LoD (U/L) 0.9 3.3 4.8 3.1

4.8

LoQ (U/L)

Linearity - ACE Alera Clinical Chemistry System

5.6

4.1

3.3

| ACE
Reagents | Low
level
tested | Upper
level
tested | Linear to: | Linear
Regression
Equation | R^2 |
|-----------------|------------------------|--------------------------|------------|----------------------------------|--------|
| ALP | 4.0
U/L | 1401 U/L | 1400 U/L | $y = 0.998x - 0.5$ | 0.9993 |
| Amylase | 4.0
U/L | 2012 U/L | 1900 U/L | $y = 1.013x + 0.2$ | 0.9974 |
| ALT | 3.1
U/L | 504 U/L | 480 U/L | $y = 1.007x - 0.17$ | 0.9992 |
| AST | 3.0
U/L | 491 U/L | 450 U/L | $y = 1.013x + 0.24$ | 0.9992 |

16

| Performance Data:

ACE Alera	Interferences - ACE Alera Clinical Chemistry System
	Interferents on
ACE Alera	ALP	Amylase	ALT	AST
	Icterus	70.6 mg/dL	30.0 mg/dL	50 mg/dL	50 mg/dL
	Hemolysis	62.5 mg/dL	62.5 mg/dL	500 mg/dL	62.5 mg/dL
	Lipemia	1000 mg/dL	1000 mg/dL	419 mg/dL	439 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		Mean	Precision (SD, %CV)
				Within-Run	Total
	ALP
U/L	Low	43	0.9, 2.2%	1.9, 4.5%
		Mid	164	2.8, 1.7%	5.5, 3.4%
		High	339	5.3, 1.6%	8.9, 2.6%
	AMYLASE
U/L	Low	45	0.9, 2.1%	1.5, 3.3%
		Mid	139	1.7, 1.2%	3.9, 2.8%
		High	311	5.0, 1.6%	7.7, 2.5%
	ALT
U/L	Low	37	1.2, 3.3%	1.8, 4.9%
		Mid	181	2.2, 1.2%	3.2, 1.8%
		High	320	5.2, 1.6%	5.2, 1.6%
	AST
U/L	Low	34	1.1, 3.3%	1.5, 4.4%
		Mid	175	3.5, 2.0%	3.6, 2.1%
		High	347	6.3, 1.8%	6.4, 1.9%

:

17

| Performance
Data:
ACE Alera | Method Comparison - ACE Alera Clinical Chemistry System
In-House ACE (x) vs. In-House ACE Alera (y) | | | |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|----------------|----------------|
| | ALP | Amylase | ALT | AST |
| n | 60 | 57 | 50 | 50 |
| Range (U/L) | 9 to 1199 | 10 to 1732 | 6 to 442 | 6 to 413 |
| Slope | 0.991 | 0.995 | 0.988 | 1.006 |
| Intercept | 0.5 | 2.9 | 1.3 | 1.5 |
| Correlation
Coefficient | 0.9999 | 0.9998 | 0.9999 | 0.9998 |
| Std. Error | 3.5 | 6.6 | 1.6 | 1.9 |
| CI Slope | 0.987 to 0.995 | 0.990 to 1.000 | 0.983 to 0.992 | 1.001 to 1.012 |
| CI Intercept | -0.5 to 1.6 | 0.9 to 4.9 | 0.8 to 1.8 | 0.9 to 2.2 |
| Conclusions: | Based on the foregoing data, the device is safe and effective for use in clinical
laboratories and physician office laboratories. These data indicate substantial equivalence
for lithium heparin plasma sample collection tubes to the predicate device's use of serum
sample collection tubes. | | | |

18

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/18/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an eagle or bird-like figure with three wing-like shapes.

Public Health Service

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

August 15, 2013

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

Re: K131351 Trade/Device Name: ACE Alkaline Phosphatase Reagent ACE Amylase Reagent ACE ALT Reagent ACE AST Reagent Regulation Number: 21 CFR 862.1050 Regulation Name: Alkaline phosphatase or isoenzymes test system Regulatory Class: II Product Code: CJE, CJE, CKA, CIT Dated: July 8, 2013 Received: July 9, 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, Drig 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, ilstig 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 mastering.

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 nequirements 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 madical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (7) CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 100-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fila.gov/AboutFDA/Conters/CDRH001 (21 CPR Par 801), please
the Center for Devices and AboutFDA/Centers/CDRHOITices/ucm I 15809.html for the Center for Devices and Radiological Health's (CDRHCHICENCESTLEMILLING Tor
note the required antitled With Li note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding of reference to premation (21CFR Party of CFR Party (21 CFR Part 803), please go to

http://www.fdagov/MedicalDevices/Safety/ReportalProblem/default.hum 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 tolli the (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): k131351_________________________________________________________________________________________________________________________________________

Device Name: ACE Alkaline Phosphatase Reagent The ACE Alkaline Phosphatase Reagent is intended for the Indications for Use: quantitative determination of alkaline phosphatase activity in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Measurements of alkaline phosphatase are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases. This test is intended for, von in, clinical laboratories and physician office laboratories. For in vitro diagnostic use only.

Device Name: ACE Amylase Reagent

Indications for Use: The ACE Amylase Reagent is intended for the quantitative determination of a-amylase activity in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas). This test is intended for use in clinical laboratories and physician office laboratories. For in vitro diagnostic use only.

Prescription Use X AND/OR Over-The-Counter Use. (21 CFR Part 801 Subpart D) (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Devices or Radiological Health (OIR)

Ruth A. Chesler -S

Division Sign-Off Office of In Vitro Devices or Radiological Health 510(k) K131351

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Indications for Use

510(k) Number (if known): ___k131351

Device Name: ACE ALT Reagent

The ACE ALT Reagent is intended for the quantitative Indications for Use: determination of alanine aminotransferase activity in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Alanine aminotransferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases. This test is intended for use in clinical laboratories and physician office laboratories. For in vitro diagnostic use only.

Device Name: ACE AST Reagent

Indications for Use: The ACE AST Reagent is intended for the quantitative determination of aspartate aminotransferase activity in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Measurements of aspartate aminotransferase are used in the diagnosis and treatment of certain types of liver and heart disease. This test is intended for use in clinical laboratories and physician office laboratories. For in vitro diagnostic use only.

Prescription Use X (21 CFR Part 801 Subpart D)

Over-The-Counter Use. (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

AND/OR

Concurrence of CDRH, Office of In Vitro Devices or Radiological Health (OIR)

Ruth A. Chesler -S

Division Sign-Off Office of In Vitro Devices or Radiological Health 510(k) ======================================================================================================================================================================= K131351

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