AUDIT MICROCV GENERAL CHEMISTRY LINEARITY SET

• K Number: K042318
• Device Name: AUDIT MICROCV GENERAL CHEMISTRY LINEARITY SET
• Manufacturer: AALTO SCIENTIFIC LTD.
• Date Cleared: 2004-12-09 ( 105 days)
• Product Code: JJY
• Regulation Number: 862.1660

Intended Use

The Audit™ MicroCV" General Chemistry Linearity Set consists of five levels of human based serum. Each level contains the following analytes: Acid Phosphatase, Albumin, Alkaline Phosphatase, ALT, Amylase, AST, Bilirubin (Total and Direct), BUN, Calcium, Chloride, Cholesterol, CO2 Creatine Kinase, Creatinine, Gamma-GT, Glucose, HDL Cholesterol, fron, LDH, LDL Cholesterol, Lactate, Lipase, Magnesium, Phosphorus, Potassium, Sodium, Total Protein, Triglycerides and Uric Acid. The five levels demonstrate a linear relationship to each other for their respective analytes, reagents and instruments. This product may be used for proficiency testing in interlaboratory surveys and to perform CLIA directed calibration verification for these same analytes with similar instrumentation in accordance with current CLIA-88 guidelines and regulations. In addition, levels B - E of this product may be used as unassayed quality control material for these analytes or as an assayed quality control material for the analyzer systems specified in the package insert. It is not intended to be used as an assayed quality control material for any other analyzer systems.

Device Description

The Device is a QC material that will be used to determine the linearity of clinical chemistry assays as defined by CLIA-88 in Federal Register 42 CFR Part 493, Department of Health and Human Services, January 24, 2003. Audit™ MicroCV™ General Chemistry Linearity Set is assayed quality control material consisting of human based serum. It is intended to simulate human patient serum samples for the purpose of monitoring the precision and to detect systematic analytical deviations of laboratory testing procedures for Acid Phosphatase, Albumin, Alkaline Phosphatase, ALT, Amylase, AST, Bilirubin (Total and Direct), BUN, Calcium, Chloride, Cholesterol, CO2 Creatine Kinase, Creatinine, Gamma-GT, Glucose, HDL Cholesterol, Iron, LDH, LDL Cholesterol, Magnesium, Comments, Potassium, Sodium, Total Protein, Lipase, La Crete, Triglycerides and Uric Acid. These five levels demonstrate a linear relationship to each other for their respective analytes, reagents and instruments. This product may also be used as unassayed quality control material for these same analytes and may be used for proficiency testing in interlaboratory surveys. In addition, this product may also be used to perform CLIA directed calibration for these same analytes with similar reagents on similar instrumentation in accordance with current CLIA-88 guidelines and regulations. The five levels QC material is to be assayed as an unknown for the determination of linearity.

Predicate Devices

K023410

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a quality control material for clinical chemistry assays and does not mention any AI or ML components.

Therapeutic

No.
This device is a linearity set and quality control material used for monitoring the precision and linearity of clinical chemistry assays, not for treating any medical condition.

Diagnostic

No

This device is a Quality Control (QC) material used to verify the linearity and precision of clinical chemistry assays, not to diagnose medical conditions in patients. It simulates human patient samples for laboratory testing purposes.

SaMD (Software as a Medical Device)

No

The device is a physical product (human based serum) used as a quality control material, not a software application.

IVD (In Vitro Diagnostic)

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

Here's why:

• Intended Use: The intended use explicitly states that the product is used for "proficiency testing in interlaboratory surveys" and to "perform CLIA directed calibration verification" for various analytes in human serum. It also mentions use as "unassayed quality control material" and "assayed quality control material" for analyzer systems. These are all activities performed in vitro (outside the body) to assess the performance of diagnostic tests.
• Device Description: The description further clarifies that the device is a "QC material" intended to "simulate human patient serum samples for the purpose of monitoring the precision and to detect systematic analytical deviations of laboratory testing procedures." This directly aligns with the definition of an IVD, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
• Performance Studies: The performance studies described involve evaluating the stability and performance of the material in the context of laboratory testing procedures, further supporting its role as an IVD.
• Predicate Device: The predicate device listed (K023410; Validate Chem 10 Calibration Verification Test Set) is also a calibration verification material, which is a type of IVD.

The device is used in vitro to evaluate the performance of other diagnostic tests that analyze human serum. This fits the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Audit™ MicroCV™ General Chemistry Linearity Set is assayed quality control material consisting of human based serum. It is intended to simulate human patient serum samples for the purpose of monitoring the precision and to detect systematic analytical deviations of laboratory testing procedures for Acid Phosphatase, Albumin, Alkaline Phosphatase, ALT, Amylase, AST, Bilirubin (Total and Direct), BUN, Calcium, Chloride, Cholesterol, CO2 Creatine Kinase, Creatinine, Gamma-GT, Glucose, HDL Cholesterol, Iron, LDH, LDL Cholesterol, Magnesium, Comments, Potassium, Sodium, Total Protein, Lipase, La Crete, Triglycerides and Uric Acid. These five levels demonstrate a linear relationship to each other for their respective analytes, reagents and instruments.

This product may also be used as unassayed quality control material for these same analytes and may be used for proficiency testing in interlaboratory surveys. In addition, this product may also be used to perform CLIA directed calibration for these same analytes with similar reagents on similar instrumentation in accordance with current CLIA-88 guidelines and regulations.

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

JJY

Device Description

The Device is a QC material that will be used to determine the linearity of clinical chemistry assays as defined by CLIA-88 in Federal Register 42 CFR Part 493, Department of Health and Human Services, January 24, 2003.

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

Not Found

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)

Stability Study:
The stability characteristics of Audit™ MicroCV™ General Chemistry Stability: Linearity Set is determined using stress stability studies (stressed at 37°C) to estimate product storage stability at 2 to 8° C by linear regression and modified Arrhenus equations. The following assumption was made: if 90 to 110% of the concentration and/or activity of the listed constituent is retained when compared to a reference vial (zero day) of the same lot stored at 2 to 8° C and tested in the same a run that constituent is considered to be stable for the corresponding real time period at 2 to 8° C.

There are five levels in the General Chemistry Linearity Set. Level "A" though "E". The Level "A" concentration is set at the lowest concentration measurable by the assay and Level "E" is set at the highest concentration measurable. All other levels are merely dilutions of these two levels. After each of the five levels of Audit™ MicroCV™ General Chemistry Linearity Set was filled, freeze/dried and labeled, vials were placed at 2 to 8° C for storage. The stress stability study was a backward performed study were selected vials (Level A and Level E) where removed from storage at different time intervals and placed in a 37° C incubator. On the day of testing, all the vials were removed from the incubator and move vials removed from storage (zero day) and all vials were tested in the same assay with QC control material according to manufacturer instructions.

For the Open Bottle Study, "TEST" vials were reconstituted with the diluents and not re-frozen. The reconstituted vials were stored at 2 to 8 ° C. The product is removed each working day from the refrigerator and open to the atmosphere from 10 to 60 minutes. On specified days, testing performed for all the analytes listed according to instrument and reagents specifications for their respective analyte.

Key Results: The "Calculated Months to Failure" values were derived using linear regression analysis to estimate failure at less than 90% (-10%) or greater than 110% (+10%) of original recovery of each constituent for each level. Based on these failure estimates from the stress stability data, the predicted storage stability of the product of Unopened Vial at 2 to 8 ° C equals 12 years, and Open Vial at 2 to 8 ° C equals 24 hours.

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

Not Found

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.

K023410

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

§ 862.1660 Quality control material (assayed and unassayed).

(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Summary

0

DEC - 9 2004

K042318

Revised Summary

In Vitro Diagnostic Devices: Aalto Scientific, Ltd. 510(k) Submissions Summary Form

Name: Aalto Scientific, Ltd. Address: 1959 Kellogg Ave, Carlsbad, CA 92008 Telephone: 760 - 431-7922 Fax Number: 760 - 431-6942 Contact Person: Alan Vekich Ext: 120 Establishment Registration Number: 2022832

Identification of the Device

Device Name:	Audit™ MicroCV™ General Chemistry Linearity Set
Proprietary/Trade name:	Audit™ MicroCV™ Linearity Set
Common Name:	General Chemistry Linearity
Classification Name:	Assay QC Material
Device Classification:	Class I
Regulation Number:	21 CFR § 862.1660
Panel:	75
Product Code:	JJY

Identification of the Predicate Device

Predicate Device Name: Manufacturer: 510(k) Number or Clearance Information: Predicate Device Labeling:

Validate Chem 10 Calibration Verification Test Set Maine Standards Company K023410

Description of the Device and reason for the submission

The Device is a QC material that will be used to determine the linearity of clinical chemistry assays as defined by CLIA-88 in Federal Register 42 CFR Part 493, Department of Health and Human Services, January 24, 2003.

1

Intended Use(s) and Indication(s) for Use of the subject device

Audit™ MicroCV™ General Chemistry Linearity Set is assayed quality control material consisting of human based serum. It is intended to simulate human patient serum samples for the purpose of monitoring the precision and to detect systematic analytical deviations of laboratory testing procedures for Acid Phosphatase, Albumin, Alkaline Phosphatase, ALT, Amylase, AST, Bilirubin (Total and Direct), BUN, Calcium, Chloride, Cholesterol, CO2 Creatine Kinase, Creatinine, Gamma-GT, Glucose, HDL Cholesterol, Iron, LDH, LDL Cholesterol, Magnesium, Comments, Potassium, Sodium, Total Protein, Lipase, La Crete, Triglycerides and Uric Acid. These five levels demonstrate a linear relationship to each other for their respective analytes, reagents and instruments.

This product may also be used as unassayed quality control material for these same analytes and may be used for proficiency testing in interlaboratory surveys. In addition, this product may also be used to perform CLIA directed calibration for these same analytes with similar reagents on similar instrumentation in accordance with current CLIA-88 guidelines and regulations.

| Name: | Validate® Chem 10 Calibration
Verification Test Set | Audit™ MicroCV™ General
Chemistry Linearity Set |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number: | K023410 | K042318 |
| Intended Use: | Validate Chem 10 Calibration
Verification Test Set solutions
are intended for in vitro
diagnostic use in verifying
calibration, validating reportable
ranges, and determining linearity
in automated, semi-automated
and manual chemistry systems. | Audit™ MicroCV™ General
Chemistry Linearity Set is
assayed quality control material
consisting of human based
serum. It is intended to simulate
human patient serum samples for
the purpose of monitoring the
precision and to detect systematic
analytical deviations of
laboratory testing procedures.
This product may also be used as
unassayed quality control
material for these same analytes
and may be used for proficiency
testing in interlaboratory surveys.
In addition, this product may also
be used to perform CLIA
directed calibration verification
for these same analytes with
similar reagents on similar
instrumentation in accordance
with current CLIA-88 guidelines
and regulations. |
| Stability Claims: | Stable until the expiration date
printed on the bottle and storage
container when stored at -10 to 20° C and handled according to
instructions. | Stored at 2-8° C and will remain
stable in the unopened vial for
twelve months from the date of
manufacture. After opening, the
contents should be reconstituted
immediately and used according |

Substantial Equivalence

2

| | | to the instrument manufacturer's
instructions. After reconstitution
material is stable 24 hours. |
|-------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Constituents: | Alkaline phosphates (ALP)
Alanine aminotransferase (ALT)
Amylase (AMY)
Aspartate aminotransferase
(AST)
Creatine kinase (CK)
x-glutamyl transferase (GGT)
Lactate dehydrogenase (LD)
Lipase (LIP)
Bilirubin, total | Alkaline phosphates (ALP)
Alanine aminotransferase (ALT)
Amylase (AMY)
Aspartate aminotransferase
(AST)
Creatine kinase (CK)
x-glutamyl transferase (GGT)
Lactate dehydrogenase (LD)
Lipase (LIP)
Bilirubin, total
Acid Phosphatase, Total
Albumin
Bilirubin, Conjugated
Calcium
Lactate
Chloride
Cholesterol
Carbon dioxide
Creatinine
Glucose
HDL Cholesterol
Iron, Total
LDL Cholesterol
Magnesium
Phosphorus
Potassium
Sodium
Total Protein
Triglycerides
Urea (BUN)
Uric Acid |
| Levels Available: | Five | Five |
| Contents: | 10 x 5mls | 5 x 5 mls |

Technological Characteristics of the Device

The five levels QC material is to be assayed as an unknown for the determination of linearity.

Performance Characteristics and Data'

Specific Performance Characteristics and Data

Method Comparison - a method comparison for each sample or matrix claimed for analysis, e.g., whole blood, capillary whole blood, serum, plasma, urine, etc.

3

Matrix:

• 1. The base matrix is mixture of two animal sera: Bovine serum and Normal Processed Human Serum that has had the lipids removed.
• 2. NaCl, LiCl, Lactic Acid, BUN (Urea), CaCl2, Creatinine, Dextose, MgCl2, NaHPO4, Uric Acid, KCI, iron, Na Acetate, Conjugate Bilirubin, Bilirubin, are ACS or Reagent Grade Commercially available chemicals. Used as an analyte adjustor.
• 3. Pyridoxal-5-Phosphate is an ACS or Reagent Grade Commercially available chemicals and used either as weighed crystal or dissolved in DI water and measured out as a liquid. Used as a stabilizer.
• 4. LD, AST/SGOT, ALT/SGPT, CK, GGT, Amylase, Lipase, Alkaline Phosphatase, and Acid Phosphatase are plant or animal derived material from approved vendors. The Vendors supply a COA and Aalto Scientific, Ltd.'s OA department confirms the claims.
• 5. Sucrose and Sorbitol are ACS or Reagent Grade Commercially available chemicals and used as a Freeze/Dry bulking agent and preservative.
• The QC materials and methods used in the manufacturing of the General Chemistry Linearity Set. Level A though E where Class A type general chemistry equipment (such as graduated cylinders) and calibrated balances. Testing materials where the reagents, calibrators and controls that were obtained from the respected manufacturers.

Precision/Reproducibility:	N/A
Linearity/assay reportable range:	N/A

4

Manufacturing:

The Linearity set is made according to NCCLS protocol #EP6-A for a five level linearity set. The dilution schemes can be found in Appendix A for a five level sample with equally spaced concentrations. Just like a Proficiency Sample Set where the actual concentrations are not important for the purposes of assessing linearity as long as dilutions are proportional. The linear range will be defined by the highest and lowest measured concentrations where the response is linear. The manufacturing targets for each analyte is listed in Table 1 and instrument and reagent used to value assignment analyte is listed in Table 2.

Analyte	Level A	Level B	Level C	Level D	Level E
Albumin	As measured	As measured	As measured	As measured	As measured
Bicarbonate (mmol/L)	10 ± 1	17.5 ± 1.75	25 ± 2.5	32.5 ± 3.25	40 ± 4
Bili, Total (mg/dL)	As measured	5 ± 2	10 ± 2	15 ± 2	20 ± 2
Bili, Conj. (mg/dL)	As measured	2.5 ± 0.25	5 ± 0.5	7.5 ± 0.75	10 ± 1
Calcium (mg/dL)	1.5 ± 0.2	5.2 ± 0.5	8.8 ± 0.9	12.4 ± 1	16 ± 1.6
Chloride (mmol/L)	50 ± 5	82 ± 8.5	113 ± 11.3	144 ± 14.5	175 ± 17.5
Cholesterol (mg/dL)	2 ± 1	125 ± 15	250 ± 25	375 ± 38	500 ± 50
HDL-Chol (mg/dL)	1 ± 1	37.5 ± 5	75 ± 8	112 ± 15	150 ± 15
Creatinine (mg/dL)	0.2 ± 0.1	6.3 ± 0.7	12.5 ± 1.25	18.8 ± 1.9	25 ± 2.5
Glucose (mg/dL)	7 ± 1	200 ± 20	394 ± 40	587 ± 59	780 ± 78
Iron (µg/dL)	As measured	144 ± 15	288 ± 30	432 ± 45	576 ± 58
Lactic Acid (mmol/L)	0.5 ± 0.1	3.25 ± 0.4	6 ± 0.6	9 ± 0.9	12 ± 1.2
Magnesium (mg/dL)	2 ± 0.2	2.8 ± 0.3	3.5 ± 0.4	4.25 ± 0.4	5 ± 0.5
Osmolality	As measured	As measured	As measured	As measured	As measured
Phosphorus (mg/dL)	1 ± 0.5	2.8 ± 0.3	4.5 ± 4.5	6.3 ± 0.7	8 ± 0.8
Potassium (mEq/dL)	1 ± 0.5	4 ± 0.8	7 ± 0.9	10 ± 1	13 ± 1.3
Protein, Total (g/dL)	2 ± 0.3	4.3 ± 0.5	6.5 ± 0.7	9 ± 0.9	11 ± 1.1
Sodium (mmol/L)	80 ± 8	103 ± 11	125 ± 13	148 ± 15	170 ± 17
Triglycerides (mg/dL)	1 ± 0.5	220 ± 22	439 ± 44	658 ± 66	876 ± 88
Uric Acid (mg/dL)	0.5 ± 0.2	5.4 ± 0.7	10.3 ± 1.1	15.2 ± 1.6	20 ± 2
Urea Nitrogen (mg/dL)	0.5 ± 0.2	32 ± 3.5	62.5 ± 6.5	94 ± 9.5	125 ± 8
A. Phosphatase (IU/L)	4 ± 2	27 ± 4	50 ± 6	73 ± 7.8	95 ± 9.5
ALT/GPT (IU/L)	3 ± 1	240 ± 24	477 ± 48	714 ± 72	950 ± 95
ALP (IU/L)	3 ± 2	303 ± 31	602 ± 61	901 ± 91	1200 ± 120
AMY (IU/L)	2 ± 1	502 ± 50	1001 ± 100	1501 ± 150	2000 ± 200
CK (IU/L)	3 ± 1	503 ± 51	1002 ± 101	1501 ± 150	2000 ± 200
AST/GOT (IU/L)	3 ± 1	240 ± 24	477 ± 48	714 ± 72	950 ± 95
x GT (IU/L)	2 ± 1	339 ± 34	676 ± 68	1013 ± 101	1350 ± 135
LDH (IU/L)	2 ± 1	239 ± 24	476 ± 48	713 ± 72	950 ± 95
LIPASE (IU/L)	2 ± 1	77 ± 8	151 ± 15	226 ± 23	300 ± 30
LDL Chol (mg/dL)	1 ± 0.5	101 ± 11	201 ± 21	301 ± 31	400 ± 40

5

*The manufacturing targets are based on the performance of the listed instrument and reagent that correspond to the listed analyte.

Value Assignment Protocol: To obtain the target values for each analyte listed in table 2, Aalto Scientific, Ltd. will perform Value Assignment according to Aalto's SOP Q-0051, titled "Value Assignment Protocol for Aalto Label Control". Protocol is to collect 30 values for each analyte listed on the instrument listed by the reagent listed. The SOP calls for three instruments or labs (if available). Ten individual assays from single evaluated vial (bottle). Require that one bottle be assayed in the morning and another in afternoon over five days time span. The thirty data points will be compiled and the average used as the target value.

Table 2: The Instrument and Reagent used for Value Assigning Analytes in Table 1.
Analyte*	Instrument	Reagents Vendor
pH	Orion	Beckman Coulter, Inc
Acid Phosphatase	Hitachi 911	Roche Diagnostic Corp
Albumin	Hitachi 911	Roche Diagnostic Corp
ALP	Hitachi 911	Thermo Trace, Ltd.
ALT/GPT	Hitachi 911	Thermo Trace, Ltd.
AMY	Hitachi 911	Thermo Trace, Ltd.
AST/GOT	Hitachi 911	Thermo Trace, Ltd.
Bicarbonate	Cobas bio	Thermo Trace, Ltd.
Bilirubin, Conjugate	Cobas bio	Hemagen Diagnostics, Inc. (Raichem)
Bilirubin, Total	Hitachi 911	Pointe Scientific, Inc.
Calcium	Hitachi 911	Pointe Scientific, Inc.
Chloride	Hitachi 911	Roche Diagnostic Corp
Cholesterol	Hitachi 911	Thermo Trace, Ltd.
CK	Hitachi 911	Pointe Scientific, Inc.
Creatinine	Hitachi 911	Roche Diagnostic Corp
Gamma GT	Hitachi 911	Roche Diagnostic Corp
Glucose	Hitachi 911	Roche Diagnostic Corp
HDL cholesterol	Hitachi 911	Roche Diagnostic Corp
Iron	Hitachi 911	Roche Diagnostic Corp
Lactic Acid	Hitachi 911	Pointe Scientific, Inc.
LDH	Hitachi 911	Thermo Trace, Ltd.
LDL cholesterol	Hitachi 911	Roche Diagnostic Corp
Lipase	Hitachi 911	Roche Diagnostic Corp
Magnesium	Cobas bio	Pointe Scientific, Inc.
Osmolality	Wescor	Wescor
Phosphorus	Hitachi 911	Roche Diagnostic Corp
Potassium	Hitachi 911	Roche Diagnostic Corp
Protein, Total	Hitachi 911	Pointe Scientific, Inc.
Sodium	Hitachi 911	Roche Diagnostic Corp

6

Triglycerides	Hitachi 911	Thermo Trace, Ltd.
Urea Nitrogen	Hitachi 911	Roche Diagnostic Corp
Uric Acid	Hitachi 911	Roche Diagnostic Corp
*Not all analytes tested are claimed. Aalto Scientific, Ltd. presented a complete list of
QA/QC testing. Aalto Scientific, Ltd. also performs Microbial growth, Moisture and
Turbidity plus an abbreviated stressed shelf life and open bottle check on each lot.

Check Linearity: The target values will be plotted against X-axis value called level 1, 2, 3, 4, and 5 and then determine that the coefficient of correlation (R4) greater or equal to 0.975 and if so, declare that linear relationship of the five levels has been confirmed.

Traceability (controls, calibrators, or methods):

The reagents, calibrators and controls used were those purchased from the manufacturer. The instrumentations used were the Roche Diagnostic Corp Hitachi 911, Roche Diagnostic Corp Cobas Bio, Wescor 5500 Osmometer and Orion 720A pH meter. An independent control was included in each assay batch and is monitored under Aalto Scientific, Ltd. QA SOP protocols.

The stability characteristics of Audit™ MicroCV™ General Chemistry Stability: Linearity Set is determined using stress stability studies (stressed at 37°C) to estimate product storage stability at 2 to 8° C by linear regression and modified Arrhenus equations. The following assumption was made: if 90 to 110% of the concentration and/or activity of the listed constituent is retained when compared to a reference vial (zero day) of the same lot stored at 2 to 8° C and tested in the same a run that constituent is considered to be stable for the corresponding real time period at 2 to 8° C.

There are five levels in the General Chemistry Linearity Set. Level "A" though "E". The Level "A" concentration is set at the lowest concentration measurable by the assay and Level "E" is set at the highest concentration measurable. All other levels are merely dilutions of these two levels. After each of the five levels of Audit™ MicroCV™ General Chemistry Linearity Set was filled, freeze/dried and labeled, vials were placed at 2 to 8° C for storage. The stress stability study was a backward performed study were selected vials (Level A and Level E) where removed from storage at different time intervals and placed in a 37° C incubator. On the day of testing, all the vials were removed from the incubator and move vials removed from storage (zero day) and all vials were tested in the same assay with QC control material according to manufacturer instructions.

For the Open Bottle Study, "TEST" vials were reconstituted with the diluents and not re-frozen. The reconstituted vials were stored at 2 to 8 ° C. The product is removed each working day from the refrigerator and open to the

7

atmosphere from 10 to 60 minutes. On specified days, testing performed for all the analytes listed according to instrument and reagents specifications for their respective analyte.

The "Calculated Months to Failure" values were derived using linear regression analysis to estimate failure at less than 90% (-10%) or greater than 110% (+10%) of original recovery of each constituent for each level. Based on these failure estimates from the stress stability data, the predicted storage stability of the product of Unopened Vial at 2 to 8 ° C equals 12 years, and Open Vial at 2 to 8 ° C equals 24 hours.

Name/place of manufacturer, packer, or distributor

Manufacturer is Aalto Scientific, Ltd. 1959 Kellogg Ave Carlsbad, CA

92008

Distributor is Audit MicroControls, Inc. 3540 W. Sahara Ave., #086 Las Vegas, NV 89102-5833

Date of last labeling revision Date: N/A

Conclusion:

The submitted material in this premarket notification for Audit™ MicroCV™ General Chemistry Linearity Set supports a substantially equivalence decision based on the performance/stability and stress stability data. Real time stability data is be collected.

Attachments

Summary of Safety and Effectiveness in the format specified under 21 CFR 807.92 or 510(k) Statement in the content and format specified under 21 CFR 807.93 Truthful and Accurate Statement

Indications for Use Form

1 A discussion of the performance data that was generated in support of the device including protocols, raw data points, graphical representation, and analyses or conclusions for the following parameters as applicable.

4Provide a copy of the labeling in draft. Labeling should be conformance to the format and order of 21 CFR 809.10(b) (see below). An explanation should be provided for each element that is either absent or not applicable. 21 CFR § 809.10 Labeling for In Vitro Diagnostic Devices. 21 CFR § 809.10(b) - labeling accompanying each product (package insert) shall bear ... in the format and order specified below except where not applicable:

8

Image /page/8/Picture/0 description: The image shows the logo for Audit MicroControls. The logo consists of a pattern of black dots on the left and the words "AUDIT" and "MicroControls" on the right. The word "AUDIT" is in a larger font than "MicroControls" and is underlined.

Audit™ MicroCV™ General Chemistry Linearity Set

For In Vitro Diagnostic Use Only.

@Audit" MicroControls", Inc., Las Vegas, NV 89102, [phone]

INTENDED USE

Audit" MicroCV" General Chemistry Linearity Set consists of five levels of human based serum. Each level contains the following analytes: Acid Phosphatase, Albumin, Alkaline Phosphatase, ALT, Amylase, AST, Bilirubin (Total and Direct), BUN, Calcium, Chloride, Cholesterol, CO2 Creatine Kinase, Creatinine, Gamma-GT, Glucose, HDL Cholesterol, Iron, Lactate, LDH, LDL Cholesterol, Lipase, Magnesium, Phosphorus, Potassium, Sodium, Total Protein, Triglycerides and Uric Acid. These five levels demonstrate a linear relationship to each other for their respective analytes, reagents and instruments'

This product may also be used as unassayed quality control material for these analytes or as an assayed quality control material for the analyzer systems specified in this package insert. It is not intended to be used as an assayed quality control material for any other analyzer systems. When used for quality control purposes, it is recommended that each laboratory establish its own means and acceptable ranges and use the values provided only as guides. In addition, it may be used for proficiency testing in interlaboratory surveys and to perform CLIA directed calibration verification2 for these same analytes with similar reagents on similar instrumentation in accordance with current CLIA-88 guidelines and regulations

SUMMARY AND PRINCIPLE

As defined in the Clinical Laboratory Improvement Amendments of 1988 (CLIA) by the Centers for Medicare and Medicaid Services (CMS) and the Centers for Disease Control (CDC), each laboratory must revalidate each test method's analytical measurement range (AMR) at least every six months as well as following changes in lots of analytically critical reagents or major system components". Good laboratory practices require that stable reference materials be used to verify the accuracy and precision of testing methods and techniques. Audit" MicroCV" General Chemistry Linearity Set may be used as one would use human serum to verify and validate the AMR.

WARNINGS AND PRECAUTIONS

Because this product is of human origin, it should be handled as though capable of transmitting infectious diseases. Each serum, plasma or whole blood donor unit used in the preparation of this material was tested by United States Food and Drug Administration (FDA) approved methods and found to be negative for antibodies to HIV and HCV and nonreactive for HBSAg. Because no test method can offer complete assurance that HIV, hepatitis B virus, and hepatitis C virus or other infectious agents are absent, this material should be handled as though capable of transmitting infectious diseases. This product may also contain other human source material for which there is no approved test. The FDA recommends such samples be handled at the Centers for Disease Control's Biosafety Level 2.

This product contains less than 0.1% sodium azide that may react with lead and copper plumbing to form potentially explosive metal azides. On disposal, flush with a large volume of water to prevent azide build-up.

Audit" MicroCV" General Chemistry Linearity Set is intended solely for in vitro diagnostic use for the purpose described on the labeling. Audit" MicroControls, Inc. shall not be liable for any unclaimed damages arising from any other usage.

Cat. No. K701M-5

Contents 5 x 5 mL plus diluent

Lot No. XXXXX, XXXXX, XXXXX, XXXXX, XXXXX

Expires XX/XX/XX

STORAGE AND STABILITY

Audit" MicroCV" General Chemistry Linearity Set is stored at 2-8°C and will remain stable in the unopened vial for twelve months from the date of manufacture. After opening, the contents should be reconstituted immediately and used according to the instrument manufacturer's instructions.

It is recommended that Audit "MicroCV" General Chemistry Linearity Set be used within twenty-four (24) hours after reconstitution and stored tightly capped at 2-8°C. Leaving the vial uncapped, or prolonging its time at room temperature, will void this reconstituted stability claim. Make sure the contents of the vial are well mixed before use.

PROCEDURE

Follow the manufacturer's instructions provided for quality control and for verifying and validating the AMR. Verify that the lot number on each vial matches the package insert. To avoid evaporation, do not leave the vial uncapped. Q.C. requirements should be performed in conformance with local, state and/or federal regulations or accreditation requirements. CLIA directed calibration verification linearity material should be run4:

• every six (6) months. 1.
• when a complete change of reagents for a procedure is introduced
• 3 when there is major preventive maintenance or replacement of critical parts that may influence test performance
• 4. when control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits.
• 5. when the laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification.

Materials provided

• · Audit™ MicroCV™ General Chemistry Linearity Set, 5 x 5 mL
• · Diluent, 5 x 5 ml.

INSTRUCTIONS FOR USE

• 1. Remove a vial from the package, reconstitute with 5ml of the diluent provided, and gently swirl occasionally for 10 minutes. Do not shake. Do not mix mechanically
• 2. Refer to instrument or assay instruction manual for quality control on verifying and validating the AMR
• 3. After sampling, replace stopper and return to original package at 2-8°C to obtain the maximum 24-hour reconstituted stability

CALCULATIONS OF RESULTS

Each set of Audit™ MicroCV" General Chemistry Linearity Set is prepared in a manner such that an equal distance exists between each consecutive level. This dilution scheme is consistent with the NCCLS recommendation2 for preparing linearity sets.

9

LIMITATIONS OF THE PROCEDURE

Make sure that each vial is brought to room temperature before testing. If the contents of any of the vials become frozen, discard all vials and request a replacement set, as the results will not be valid. If the diluent becomes cloudy, do not use as bacterial contamination may be suspected.

2Federal Register 42 CFR Part 493, Department of Haath and Human Services, January 24, 2003; p.3691.

3Faderal Register 42 CFR Part 483, Department of Health and Human Services, January 24, 2003; 5483.2

"Federal Register 42 CFR Part 483, Department of Health and Human Services, January 24, 2003, 5483, 120 (1) (1) (1)

on guidelines provided by The National Committee for Clinical Laboratory Standards (NCCCS) in

ivaluation of the Linearity of Quantifative Heasurement Procedures: A Statistica approved guideline
Guideline", April 20

EXPECTED VALUES

Each lot of product is manufactured such that a linear relationship exists among levels. The analyte concentrations in this insert were derived from multiple replicate analyses on the instruments indicated. Actual results obtained may vary depending on instrumentation, methodology and assay temperature. Results may also be dependent on the accuracy of the instrument/reagent system calibration. The degree of acceptable non-linearity is an individual judgment based on methodology, clinical significance and medical decision levels of the test analyte.

The material and information presented here in no manner constitutes an overruling of any federal, state or other regulatory body's regulations and/or guidelines

ORDERING INFORMATION

| Product
Number | Product
Description | Product
Packaging |
|-------------------|-----------------------------------------------|----------------------|
| K701M-5 | Audit MicroCV General Chemistry Linearity Set | 5 x 5 mL |

Analytes include:

	Instrument	Units	mean	range	mean	range	mean	range	mean	range	mean	range
Acid
Phosphatase,
Total	Hitachi 911	IU/L	x	x-x	x	x-x	x	x-x	x	x-x	x	x-x
Albumin	Hitachi 911	g/dL	x	x-x	x	x-x	x	x-x	x	x-x	x	x-x
Alkaline
Phosphatase	Hitachi 911	IU/L	x	x-x	x	x-x	x	x-x	x	x-x	x	x-x
ALT	Hitachi 911	IU/L	x	x-x	x	x-x	x	x-x	x	x-x	x	x-x
Amylase	Hitachi 911	IU/L	x	x-x	x	x-x	x	x-x	x	x-x	x	x-x
AST	Hitachi 911	IU/L	x	x-x	x	x-x	x	x-x	x	x-x	x	x-x
Bilirubin, Direct	Hitachi 911	mg/dL	x	x-x	x	x-x	x	x-x	x	x-x	x	x-x
Bilirubin,
Total	Hitachi 911	mg/dL	x	x-x	x	x-x	x	x-x	x	x-x	x	x-x
Calcium	Hitachi 911	mg/dL	x	x-x	x	x-x	x	x-x	x	x-x	x	x-x
CO2	Hitachi 911	mEq/L	x	x-x	x	x-x	x	x-x	x	x-x	x	x-x
Chloride	Hitachi 911	mEq/L	x	x-x	x	x-x	x	x-x	x	x-x	x	x-x
Cholesterol	Hitachi 911	mg/dL	x	x-x	x	x-x	x	x-x	x	x-x	x	x-x
Creatine Kinase	Hitachi 911	IU/L	x	x-x	x	x-x	x	x-x	x	x-x	x	x-x
Creatinine	Hitachi 911	mg/dL	x	x-x	x	x-x	x	x-x	x	x-x	x	x-x
Gamma-GT	Hitachi 911	IU/L	x	x-x	x	x-x	x	x-x	x	x-x	x	x-x
Glucose	Hitachi 911	mg/dL	x	x-x	x	x-x	x	x-x	x	x-x	x	x-x
HDL Cholesterol	Hitachi 911	mg/dL	x	x-x	x	x-x	x	x-x	x	x-x	x	x-x
Iron, Total	Hitachi 911	ug/L	x	x-x	x	x-x	x	x-x	x	x-x	x	x-x
Lactate	Hitachi 911	mg/dL	x	x-x	x	x-x	x	x-x	x	x-x	x	x-x
LDH	Hitachi 911	IU/L	x	x-x	x	x-x	x	x-x	x	x-x	x	x-x
LDL Cholesterol	Hitachi 911	mg/dL	x	x-x	x	x-x	x	x-x	x	x-x	x	x-x
Lipase	Hitachi 911	IU/L	x	x-x	x	x-x	x	x-x	x	x-x	x	x-x
Magnesium	Hitachi 911	mg/dL	x	x-x	x	x-x	x	x-x	x	x-x	x	x-x
Phosphorus	Hitachi 911	mg/dL	x	x-x	x	x-x	x	x-x	x	x-x	x	x-x
Potassium	Hitachi 911	mEq/L	x	x-x	x	x-x	x	x-x	x	x-x	x	x-x
Sodium	Hitachi 911	mEq/L	x	x-x	x	x-x	x	x-x	x	x-x	x	x-x
Total Protein	Hitachi 911	g/dL	x	x-x	x	x-x	x	x-x	x	x-x	x	x-x
Triglycerides	Hitachi 911	mg/dL	x	x-x	x	x-x	x	x-x	x	x-x	x	x-x
Urea (BUN)	Hitachi 911	mg/dL	x	x-x	x	x-x	x	x-x	x	x-x	x	x-x
Uric Acid	Hitachi 911	mg/dL	x	x-x	x	x-x	x	x-x	x	x-x	x	x-x

*AUDIT MicroControls, Inc. does not recommend using Level A for quality control purposes as the levels may be too low to measure

10

Image /page/10/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Alan J. Vekich Scientist Aalto Scientific, Ltd. 1959 Kellogg Avenue Carlsbad, CA 92008

DEC - 9 2004

Re: K042318

Trade/Device Name: Audit™ MicroCVIM General Chemistry Linearity Set Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: November 22, 2004 Received: November 22, 2004

Dear Mr. Vekich:

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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21. Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

11

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Sincerely yours,

Cornelia B. Parks

Cornelia B. Rooks, MA Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

12

Indications for Use

510(k) Number (if known): K042318

Audit™ MicroCV™ General Chemistry Linearity Set Device Name:

Indications For Use:

The Audit™ MicroCV" General Chemistry Linearity Set consists of five levels of human based serum. Each level contains the following analytes: Acid Phosphatase, Albumin, Alkaline Phosphatase, ALT, Amylase, AST, Bilirubin (Total and Direct), BUN, Calcium, Chloride, Cholesterol, CO2 Creatine Kinase, Creatinine, Gamma-GT, Glucose, HDL Cholesterol, fron, LDH, LDL Cholesterol, Lactate, Lipase, Magnesium, Phosphorus, Potassium, Sodium, Total Protein, Triglycerides and Uric Acid. The five levels demonstrate a linear relationship to each other for their respective analytes, reagents and instruments.

This product may be used for proficiency testing in interlaboratory surveys and to perform CLIA directed calibration verification for these same analytes with similar instrumentation in accordance with current CLIA-88 guidelines and regulations.

In addition, levels B - E of this product may be used as unassayed quality control material for these analytes or as an assayed quality control material for the analyzer systems specified in the package insert. It is not intended to be used as an assayed quality control material for any other analyzer systems.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Carol Bemeen
Division Sign-Off

of in Vince Digan

510441 K04 23/18

Page 1 of