K Number

Device Name

VITALAB AMYLASE REAGENT

Manufacturer

CLINICAL DATA, INC.

Date Cleared

2004-03-11

(9 days)

Product Code

JFJ

Regulation Number

862.1070

Intended Use

The Vitalab c .- Amylase Reagent Kit is intended for use with the Vitalab Selectra Analyzer as a system for the quantitative determination of a-amylase in serum and plasma. Amylase results may be used for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).

Device Description

The Vitalab a-Amylase Reagent is a single-part reagent for use with the Vitalab Selectra Analyzer. This reagent determines amylase through the cleavage of 2-chloro-4-nitrophenyl-a-D-maltotrioside (CNP-a-G3) to produce 2-chloro-4-nitrophenol.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a reagent kit for a laboratory analyzer and does not mention any AI or ML components.

Therapeutic

No
This device is a reagent kit used for the quantitative determination of a-amylase in serum and plasma, which aids in the diagnosis and treatment of pancreatitis. It is an in vitro diagnostic device, not a therapeutic device.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the amylase results obtained from this device "may be used for the diagnosis and treatment of pancreatitis (inflammation of the pancreas)." This directly indicates its role in disease diagnosis.

SaMD (Software as a Medical Device)

The device is a reagent kit intended for use with a specific analyzer, indicating it is a chemical component used in a laboratory setting, not a software-only device.

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 reagent kit is for the "quantitative determination of a-amylase in serum and plasma." Serum and plasma are biological specimens taken from the human body.
Purpose: The intended use also states that the results "may be used for the diagnosis and treatment of pancreatitis." This indicates the device is used to provide information for medical purposes.
Device Description: The description details a reagent used to perform a chemical reaction on a biological sample (serum and plasma) to measure a specific analyte (a-amylase).

These characteristics align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the compatibility of a transplant.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Vitalab ot-Amylase Reagent Kit is intended for use with the Vitalab Selectra Analyzer for the quantitative determination of a-amylase in serum and plasma. Amylase results may be used for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).

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

JFJ

Device Description

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)

Usable Range: The linear range of the Vitalab α-Amylase Reagent is 5 to 1,600 U/L using the default sample volume and 1,200 to 3,200 U/L using the reduced sample volume in rerun mode. The recoveries of linearity related solutions that span the linear range are compared to dilution factors using least squares regression, which is forced through the origin.
Default sample volume (Vitalab Recoveries) = 0 U/L + 131 x (Dilution Factor), r = 0.9999, syx = 7.2 U/L, n = 28
Rerun sample volume (Vitalab Recoveries) = 0 U/L + 133 x (Dilution Factor), r = 0.9999, syx = 17 U/L, n = 60

Detection Limit: The detection limit is shown through the repetitive assay of normal saline. The observed mean and standard deviation of a 30 replicate run are 0.3 and 1.8 U/L respectively. The detection limit, calculated as the mean plus two standard deviations of the recovery values, is 0.4 U/L.

Precision: Precision is demonstrated by the replicate assay of control serum. Precision statistics, calculated analogous to the method described in NCCLS Guideline EP3-T, are shown below.
Sample: Default Serum 1, n=60, mean=98, 1SD=1.0, %CV=1.0%, 1SD=1.5, %CV=1.5%
Sample: Default Serum 2, n=60, mean=565, 1SD=3.6, %CV=0.6%, 1SD=5.0, %CV=0.9%
Sample: Default Serum 3, n=60, mean=1,034, 1SD=7.0, %CV=0.7%, 1SD=9.7, %CV=0.9%
Sample: Rerun Serum 1, n=60, mean=1,961, 1SD=17, %CV=0.9%, 1SD=25, %CV=1.3%
Sample: Rerun Serum 2, n=60, mean=2,517, 1SD=26, %CV=1.0%, 1SD=41, %CV=1.6%
Sample: Rerun Serum 3, n=60, mean=3,002, 1SD=40, %CV=1.3%, 1SD=50, %CV=1.7%

Correlation: Mixed serum and plasma specimens, collected from adult patients, were assayed for α-amylase using the Vitalab Selectra E Analyzer and another commercially available method. Results were compared by Deming regression and the following statistics were obtained.
Selectra = -6 U/L + 1.086 x Competitive Reagent
sy.x = 4.0 U/L n = 120 range = 26 - 1049 U/L

Stability: The 14 day onboard reagent stability claim is documented through the assay of serum controls over the claimed period. The statistical estimates of total imprecision are less than 2 U/L or 1.2% for all controls.

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.

Roche a-Amylase EPS ver.2 Reagent, product no. 03183742

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

§ 862.1070 Amylase test system.

(a)
Identification. An amylase test system is a device intended to measure the activity of the enzyme amylase in serum and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).(b)
Classification. Class II.

Summary

K040534

Brea, CA 92821 T (714) 672-3553 F (714) 672-3554

Summary of 510(k) Safety and Effectiveness Information Vitalab a-Amylase Reagent

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

Submitted by:

| | Clinical Data, Inc.
1075 West Lambert Road, Building D
Brea, California 92861 | |
|-----------------|-------------------------------------------------------------------------------------|----------------------------|
| Contact Person: | Wynn Stocking | Regulatory Affairs Manager |

January 21, 2003 Date Submitted:

Device Names:

Proprietary name:	Vitalab Amylase Reagent
Common name:	Amylase reagent
Classification Name:	Catalytic methods, amylase

Device Description:

Intended Use:

Predicate Device:

Roche a-Amylase EPS ver.2 Reagent, product no. 03183742, which is currently marketed by Roche Diagnostics Corp. of Indianapolis, IN

Summary of Performance Data:

| Usable Range: The linear range of the Vitalab α-Amylase Reagent is 5 to 1,600 U/L using the default sample volume
and 1,200 to 3,200 U/L using the reduced sample volume in rerun mode. The recoveries of linearity
related solutions that span the linear range are compared to dilution factors using least squares

regression, which is forced through the origin.
Default sample volume
(Vitalab Recoveries) = 0 U/L + 131 x (Dilution Factor), r = 0.9999, syx = 7.2 U/L, n = 28
Rerun sample volume
(Vitalab Recoveries) = 0 U/L + 133 x (Dilution Factor), r = 0.9999, syx = 17 U/L, n = 60
Detection Limit: The detection limit is shown through the repetitive assay of normal saline. The observed mean and
standard deviation of a 30 replicate run are 0.3 and 1.8 U/L respectively. The detection limit,
calculated as the mean plus two standard deviations of the recovery values, is 0.4 U/L.
Precision:	Precision is demonstrated by the replicate assay of control serum. Precision statistics, calculated
analogous to the method described in NCCLS Guideline EP3-T, are shown below.
	Sample	n	mean	1SD	%CV	1SD	%CV
	Default
	Serum 1	60	98	1.0	1.0%	1.5	1.5%
	Serum 2	60	565	3.6	0.6%	5.0	0.9%
	Serum 3	60	1,034	7.0	0.7%	9.7	0.9%
	Rerun
	Serum 1	60	1,961	17	0.9%	25	1.3%
	Serum 2	60	2,517	26	1.0%	41	1.6%
	Serum 3	60	3,002	40	1.3%	50	1.7%
Correlation:	Mixed serum and plasma specimens, collected from adult patients, were assayed for α-amylase using
the Vitalab Selectra E Analyzer and another commercially available method. Results were compared
by Deming regression and the following statistics were obtained.
	Selectra = -6 U/L + 1.086 x Competitive Reagent
sy.x = 4.0 U/L n = 120 range = 26 - 1049 U/L
Stability:	The 14 day onboard reagent stability claim is documented through the assay of serum controls over the
claimed period. The statistical estimates of total imprecision are less than 2 U/L or 1.2% for all
controls

. . . .

Image /page/2/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 enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR 1 1 2004

Clinical Data, Inc. c/o: Mr. Ned E. Devine, Jr. Entela, Inc. 3033 Madison Avenue, SE Grand Rapids, MI 49548

Re: K040534 Trade/Device Name: Vitalab a-Amylase Reagent Regulation Number: 21 CFR 862.1070 Regulation Name: Amylase test system Regulatory Class: Class II Product Code: JFJ Dated: March 2, 2004 Received: March 2, 2004

Dcar Mr. Devine:

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 docs 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).

Page 2

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 (301) 594-3084. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely vours.

Jean M. Cooper, MS, DVM.

Yean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

510(k) Number (if known):

K040534

Device Name:

Vitalab a-Amylase Reagent

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign Off

Office of In Vitro Diagnostic
Device Evaluation and Safety

510(k) K040534

Prescription Use
(Per 21 CFR 801.109) √

ાર

Over-The-Counter Use

(Optional Format 1-2-96)