Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a chemistry analyzer and reagent disc that perform quantitative measurements based on chemical reactions. There is no mention of AI or ML in the intended use, device description, or performance studies.

Therapeutic

No
The device is an in vitro diagnostic (IVD) product used for quantitative determination of various analytes in biological samples, primarily for diagnosis and monitoring of conditions, not for direct therapeutic intervention on a patient.

Diagnostic

Yes

The device is intended for the quantitative determination of various substances (creatine kinase, creatinine, glucose, potassium, total carbon dioxide, and urea nitrogen) in biological samples, and the "Indications for Use" section explicitly states that measurements of these substances are "used in the diagnosis and treatment" of numerous medical conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly details a physical reagent disc designed to process blood samples, indicating it is a hardware component and not software-only.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is "intended to be used for the in vitro quantitative determination of creatine kinase, creatinine, glucose, potassium, total carbon dioxide and urea nitrogen in heparinized whole blood, heparinized plasma, or serum". The term "in vitro" is a key indicator of an IVD.
Sample Type: The device analyzes biological samples (whole blood, plasma, or serum) taken from the human body.
Purpose: The measurements obtained are used "in the diagnosis and treatment" of various medical conditions, which is a primary function of IVDs.
Device Description: The description details how the device processes the biological sample to perform chemical reactions for analysis.

All of these points align with the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Piccolo MetLyte 7 Reagent Disc, used with the Piccolo Point-of-Care Chemistry Analyzer is intended to be used for the in vitro quantitative determination of creatine kinase, creatinine, glucose, potassium, total carbon dioxide and urea nitrogen in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.

Indications for Use:
Creatine Kinase The creatine kinase assay is used for the quantitation of creatine kinase in human heparinized whole blood, heparinized plasma, or serum. Measurements of creatine kinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction, progressive muscular dystrophy, dermatomyositis, rhabdomyolysis due to drug ingestion, hyperosmolality, autoimmune disease, delirium tremens, convulsions, Crush syndrome, hypothyroidism, surgery, severe exercise, intramuscular injection, physical inactivity, decreased muscle mass.

The creatinine assay is used for the quantitation of creatinine in Creatinine human heparinized whole blood, heparinized plasma, or serum. Creatinine measurements are used in the diagnosis and treatment of renal diseases and monitoring of renal dialysis.

Glucose The glucose assay is used for the quantitation of glucose in human heparinized whole blood, heparinized plasma, or serum. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders, including adult and juvenile diabetes mellitus and hypoglycemia.

The potassium assay is used for the quantitation of potassium in Potassium human heparinized whole blood, heparinized plasma, or serum. Potassium measurements are used in the diagnosis and treatment of renal glomerular or tubular disease, adrenocortical insufficiency, diabetic ketoacidosis, excessive intravenous potassium therapy, sepsis, panhypopituitarism, in vitro hemolysis, hyperaldosteronism, malnutrition, hyperinsulinism, metabolic alkalosis and gastrointestinal loss.

Total Carbon Dioxide The total carbon dioxide assay is used for the quantitation of total carbon dioxide in human heparinized whole blood, heparinized plasma, or serum. Total carbon dioxide measurements are used in the diagnosis and treatment of primary MetLyte 7 alkalosis and primary respiratory alkalosis and acidosis.

The urea nitrogen assay is used for the quantitation of urea Urea Nitrogen nitrogen in human heparinized whole blood, heparinized plasma, or serum. Urea nitrogen measurements are used in the diagnosis and treatment of renal and MetLyte 7 diseases.

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

JLB

Device Description

The Piccolo MetLyte 7 Reagent Disc is designed to separate a heparinized whole blood sample into plasma and blood cells. The disc meters the required quantity of plasma and diluent, mixes the plasma with diluent, and delivers the mixture to the reaction cuvettes along the disc perimeter. The diluted plasma mixes with the reagent beads, initiating the chemical reactions that are then monitored by the analyzer. Alternately, the disc may also be used with serum.

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 laboratory setting or point-of-care location.

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)

Brief discussion of the clinical and nonclinical tests relied on for a determination of substantial equivalence.
Tables 4 - 5 summarize the results of clinical and non-clinical tests performed using the Piccolo MetLyte 7 Reagent Disc.

Linearity:
Data for creatine kinase, potassium and total carbon dioxide were found to be statistically linear at the 99% significance level by the F-test.

Precision:
Precision studies were designed to evaluate within-run and total precision of the analytes included on the Piccolo® MetLyte 7 Reagent Disc when run on the Piccolo Point-of-Care Chemistry Analyzer.

Sample Type Comparison:
A study was conducted to examine to compare venous whole blood. finger puncture whole blood and serum on the Piccolo® Point-of-Care Chemistry Analyzer.

Serum and whole blood comparability were established for each analyte and serum, whole blood and finger stick comparability were established for creatine kinase when run on the Piccolo Point-of-Care Chemistry Analyzer.

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

Accuracy (Creatine Kinase):
Sample size (n): 47
Corr. Coefficient: 0.967
Slope: 1.194
Intercept: -24.983
SEE: 9.050
R-Square: 0.934

Accuracy (Potassium):
Sample size (n): 58
Corr. Coefficient: 0.969
Slope: 0.863
Intercept: 0.573
SEE: 0.141
R-Square: 0.939

Accuracy (Total Carbon Dioxide):
Sample size (n): 60
Corr. Coefficient: 0.947
Slope: 0.903
Intercept: 2.444
SEE: 0.837
R-Square: 0.900

Linearity:
Creatine Kinase: F-Ratio 0.11, Slope 1.00, Intercept -7.45, Corr. Coefficient 1.00
Potassium: F-Ratio 0.37, Slope 1.05, Intercept 0.03, Corr. Coefficient 1.00
Total Carbon Dioxide: F-Ratio 0.88, Slope 1.09, Intercept -0.71, Corr. Coefficient 0.97

Precision (Within-Run & Total, n=120):
Creatine Kinase (Moni-Trol 1): Mean 134, SD 2.7, CV 2.0 (Within-Run & Total)
Creatine Kinase (Moni-Trol 2): Mean 526, SD 7.7, CV 1.5 (Within-Run & Total)
Potassium (Moni-Trol 1): Within-Run (Mean 6.1, SD 0.32, CV 5.2), Total (Mean 6.1, SD 0.35, CV 5.7)
Potassium (Moni-Trol 2): Within-Run (Mean 4.1, SD 0.24, CV 5.9), Total (Mean 4.1, SD 0.26, CV 6.3)
Total Carbon Dioxide (Moni-Trol 1): Mean 21, SD 2.29, CV 10.7 (Within-Run & Total)
Total Carbon Dioxide (Moni-Trol 2): Mean 10, SD 0.90, CV 8.6 (Within-Run & Total)

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.

K830805, CK: K834502, CO2 K844987

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

§ 862.1210 Creatine test system.

(a)
Identification. A creatine test system is a device intended to measure creatine (a substance synthesized in the liver and pancreas and found in biological fluids) in plasma, serum, and urine. Measurements of creatine are used in the diagnosis and treatment of muscle diseases and endocrine disorders including hyperthyroidism.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Summary

0

AUG 26 1000

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS APPENDIX E

1

1320 Chesapeake Terrace. Sunnyvale, Phone 408 . 734-0200 Fax 408 . 73

862.1600

Image /page/1/Picture/1 description: The image shows the word "ABAXIS" in bold, sans-serif font. A curved line starts from the top right of the letter "X", loops around the letters "I" and "S", and ends at the bottom right of the letter "S". The word and the curved line together form a logo.

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: __

1. Applicant Information:

| Date Prepared:
Name:
Address: | June 22, 1999
Abaxis, Inc.
1320 Chesapeake Drive
Sunnyvale, CA 94089 | |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Contact Person:
Phone Number:
Fax Number: | Lisa G. McGrath
(408) 745-6880
(408) 734-2874 | |
| Device Information: | | |
| Classification
Trade Name: | Class II
Creatine Kinase, Potassium and Total Carbon Dioxide
test systems included on the Piccolo MetLyte 7 Reagent Disc | |
| Classification Name: | Bicarbonate/Bicarbonate test system
Creatinine Kinase test system | 862.1160
862.1215 |

(Substantial equivalence for creatinine kinase, glucose and urea nitrogen, which are test systems included on the Piccolo MetLyte 7 Reagent Disc, were established previously in K934592 and K942782, therefore these test systems are not included in this summary.)

Potassium test system

2

ldentification of legally marketed device to which the submitter claims 3. equivalence:

The following table identifies the legally marketed device to which Abaxis claims equivalence:

Subject Device	Predicate Device
	Predicate
Device	Manufacturer	510(k) Number	Date of SE
Determination
Piccolo®
Potassium Test
System	KNA™ 2
Sodium-
Potassium
Analyzer	Radiometer
America, Inc.	K830805	4/8/83
Piccolo Creatine
Kinase and Total
Carbon Dioxide
Test System	Roche
Reagents
for carbon
dioxide and
creatine
kinase on
the COBAS
FARA™
Chemistry
System	Roche
Diagnostic
Systems, Inc.	CK: K834502
CO2 K844987	2/27/84
1/18/85

4. Description of the Device:

The Piccolo MetLyte 7 Reagent Disc is designed to separate a heparinized whole blood sample into plasma and blood cells. The disc meters the required quantity of plasma and diluent, mixes the plasma with diluent, and delivers the mixture to the reaction cuvettes along the disc perimeter. The diluted plasma mixes with the reagent beads, initiating the chemical reactions that are then monitored by the analyzer. Alternately, the disc may also be used with serum.

5. Statement of Intended Use:

The Piccolo MetLyte 7 Reagent Disc run on the Piccolo Point-of-Care Chemistry Analyzer is intended to be used for the in vitro quantitative determination of creatine kinase, creatinine, glucose, potassium, total carbon dioxide and urea nitrogen in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.

6. Summary of the technological characteristics of the new device in comparison to those of the predicate device:

Tables 1 - 3 outline the technological characteristics of the Piccolo MetLyte 7 Reagent Disc (for creatine kinase, potassium and total carbon dioxide) in comparison to those of the legally marketed predicate devices.

3

Table 1: Specification Comparison Creatine Kinase Test System
	Piccolo® Point-of-Care
Chemistry Analyzer	COBAS FARATM Chemistry
System
Intended Use	quantitative analysis of
creatine kinase	quantitative determination of
creatine kinase
Methodology	isoenzymes	isoenzymes
Sample Type	whole blood, plasma,
serum	serum
Sensitivity	0.0001 A/min/U/L	0.0001 A/min/U/L
Reagents	dry test-specific reagent
beads	liquid mono reagent
Temperature	37°C	37°C
Calibration	bar code with disc-
specific calibration data	pre-set calibration
Assay Range	5 - 5,000 U/L	0 - 2,000 U/L
Performance Characteristics
Accuracy:
Sample size (n)	47
Range of Samples Tested	6.2 - 813.2
Corr. Coefficient	0.967
Slope	1.194
Intercept	-24.983
SEE	9.050
R-Square	0.934

Table 1: Specification Comparison Creatine Kinase Test System

Table 2: Specification Comparison: Potassium Test System

Table 2. Specification Comparison: Potassium Test System
	Piccolo Point-of-Care
Chemistry Analyzer	Radiometer KNA™ 2
Sodium-Potassium Analyzer
Intended Use	quantitative analysis of
potassium	quantitative determination of
potassium
Methodology	enzymatic activation	ion-selective electrodes
Sample Type	whole blood, plasma,
serum	whole blood, plasma, serum,
urine
Sensitivity	0.024 A/min/mmol/L	0.58 (mmol/L)/(mV)
Reagents	dry, test specific reagent
beads	N/A
Temperature	37° C	37° C
Calibration	bar code with disc-
specific calibration data	automatic 1 point calibration
every 2 hours; 2 point
calibration every 8 hours
Performance Characteristics
Assay Range	1.5 - 8.5 mmol/L	1.0 - 99.9 mmol/L
Accuracy:
Sample size (n)	58
Range of Samples Tested	2.0 - 6.8
Corr. Coefficient	0.969
Slope	0.863
Intercept	0.573
SEE	0.141
R-Square	0.939

4

| | Piccolo® Point-of-Care
Chemistry Analyzer | COBAS FARA™ Chemistry
System |
|-----------------------------|--------------------------------------------------|------------------------------------------------------------------------------------------|
| Intended Use | quantitative analysis of
total carbon dioxide | quantitative determination of
total carbon dioxide |
| Methodology | enzymatic | enzymatic using phos-
phoenol pyruvate carbo-
xylase and malate de-
hydrogenase |
| Sample Type | whole
blood, plasma, serum | serum and plasma |
| Sensitivity | 0.0037 A/min/mmol/L | 0.0427 A/mmol/L |
| Reagents | dry test-specific reagent
beads | liquid substrate reagent 1 and
liquid enzyme reagent 2 |
| Temperature | 37° C | 37° C |
| Calibration | bar code with disc-
specific calibration data | Roche calibrator serum
every 6 months |
| Performance Characteristics | | |
| Assay Range | 5 - 40 mmol/L | 0 - 40 mmol/L |
| Accuracy: | | |
| Sample size (n) | 60 | |
| Range of Samples Tested | 6.1 -38.5 | |
| Corr. Coefficient | 0.947 | |
| Slope | 0.903 | |
| Intercept | 2.444 | |
| SEE | 0.837 | |
| R-Square | 0.900 | |

Specification Comparison: Total Carbon Dioxide Test System Tahle 3-

7. Brief discussion of the clinical and nonclinical tests relied on for a determination of substantial equivalence.

Tables 4 - 5 summarize the results of clinical and non-clinical tests performed using the Piccolo MetLyte 7 Reagent Disc.

Linearity:

Data for creatine kinase, potassium and total carbon dioxide were found to be statistically linear at the 99% significance level by the F-test.

Table 4: Summary of Linearity

	Creatine Kinase	Potassium	Total Carbon Dioxide
F-Ratio	0.11	0.37	0.88
Slope	1.00	1.05	1.09
Intercept	-7.45	0.03	-0.71
Corr. Coefficient	1.00	1.00	0.97

(99% Critical F 2.99)

5

Precision:

Precision studies were designed to evaluate within-run and total precision of the analytes included on the Piccolo® MetLyte 7 Reagent Disc when run on the Piccolo Point-of-Care Chemistry Analyzer.

Table 5: Within-Run and Total Precision for Creatine Kinase, Potassium and Total Carbon Dioxide Run on the Piccolo Point-of-Care Chemistry Analyzer ^

| Analyte | Within-Run
(n = 120) | Total
(n= 120) |
|-------------------------------|-------------------------|-------------------|
| Creatine Kinase (U/L) | | |
| Moni-Trol 1
Mean | 134 | 134 |
| SD | 2.7 | 2.7 |
| CV | 2.0 | 2.0 |
| Moni-Trol 2
Mean | 526 | 526 |
| SD | 7.7 | 7.7 |
| CV | 1.5 | 1.5 |
| Potassium (mmol/L) | | |
| Moni-Trol 1
Mean | 6.1 | 6.1 |
| SD | 0.32 | 0.35 |
| CV | 5.2 | 5.7 |
| Moni-Trol 2
Mean | 4.1 | 4.1 |
| SD | 0.24 | 0.26 |
| CV | 5.9 | 6.3 |
| Total Carbon Dioxide (mmol/L) | | |
| Moni-Trol 1
Mean | 21 | 21 |
| SD | 2.29 | 2.29 |
| CV | 10.7 | 10.7 |
| Moni-Trol 2
Mean | 10 | 10 |
| SD | 0.90 | 0.90 |
| CV | 8.6 | 8.6 |

A Results pooled from 6 instruments each running 20 discs.

6

Sample Type Comparison:

A study was conducted to examine to compare venous whole blood. finger puncture whole blood and serum on the Piccolo® Point-of-Care Chemistry Analyzer.

Serum and whole blood comparability were established for each analyte and serum, whole blood and finger stick comparability were established for creatine kinase when run on the Piccolo Point-of-Care Chemistry Analyzer.

8. Conclusions

The clinical and non-clinical tests performed for creatine kinase, potassium and total carbon dioxide when run on the Piccolo Point-of-Care Chemistry Analyzer demonstrate that the test systems are as safe, effective and performs as well as the legally marketed devices identified above.

7

Image /page/7/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG 26 1999

Ms. Lisa G. McGrath Regulatory Affairs Specialist Abaxis, Inc. 1320 Chesapeake Terrace Sunnyvale, California 94089

Re: K992140

Trade Name: Piccolo® MetLyte 7 Reagent Disc Regulatory Class: I reserved Product Code: JLB Dated: June 22, 1999 Received: June 24, 1999

Dear Ms. McGrath:

.. .

We have reviewed your Section 510/k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

8

Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrlv/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D. M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

9

Indications for Use

510(k) Number (if known):	K992140
---------------------------	---------

Device Name:

Piccolo® MetLyte 7 Reagent Disc

Intended Use:

The Piccolo MetLyte 7 Reagent Disc, used with the Piccolo Point-of-Care Chemistry Analyzer is intended to be used for the in vitro quantitative determination of creatine kinase, creatinine, glucose, potassium, total carbon dioxide and urea nitrogen in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.

Indications for Use:

Creatine Kinase The creatine kinase assay is used for the quantitation of creatine kinase in human heparinized whole blood, heparinized plasma, or serum. Measurements of creatine kinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction, progressive muscular dystrophy, dermatomyositis, rhabdomyolysis due to drug ingestion, hyperosmolality, autoimmune disease, delirium tremens, convulsions, Crush syndrome, hypothyroidism, surgery, severe exercise, intramuscular injection, physical inactivity, decreased muscle mass.

The creatinine assay is used for the quantitation of creatinine in Creatinine human heparinized whole blood, heparinized plasma, or serum. Creatinine measurements are used in the diagnosis and treatment of renal diseases and monitoring of renal dialysis.

Glucose The glucose assay is used for the quantitation of glucose in human heparinized whole blood, heparinized plasma, or serum. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders, including adult and juvenile diabetes mellitus and hypoglycemia.

The potassium assay is used for the quantitation of potassium in Potassium human heparinized whole blood, heparinized plasma, or serum. Potassium measurements are used in the diagnosis and treatment of renal glomerular or tubular disease, adrenocortical insufficiency, diabetic ketoacidosis, excessive intravenous potassium therapy, sepsis, panhypopituitarism, in vitro hemolysis, hyperaldosteronism, malnutrition, hyperinsulinism, metabolic alkalosis and gastrointestinal loss.

Total Carbon Dioxide The total carbon dioxide assay is used for the quantitation of total carbon dioxide in human heparinized whole blood, heparinized plasma, or serum. Total carbon dioxide measurements are used in the diagnosis and treatment of primary MetLyte 7 alkalosis and primary respiratory alkalosis and acidosis.

10

Indications for Use, Page 2

The urea nitrogen assay is used for the quantitation of urea Urea Nitrogen nitrogen in human heparinized whole blood, heparinized plasma, or serum. Urea nitrogen measurements are used in the diagnosis and treatment of renal and MetLyte 7 diseases.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use __
(Per 21 CFR 801.109)

OR

Over- The Counter Use __
(Optional Format 1-2-96)

Jev Harcey