MULTI-CHEMISTRY STANDARD KIT, URIC ACID STANDARD KIT, URINE CHEMISTRY STARDAND KIT, URINE URIC ACID STANDARD KIT, CHOLES by VERICHEM LABORATORIES, INC.

The Carbon Dioxide Standard Kit is an in vitro diagnostic product intended forcalibration or calibration verification of carbon dioxide test systems.
The Urine Chemistry Standard Kit is an in vitro diagnostic product intended forcalibration or calibration verification of clinical chemistry test systems.
The Urine Uric Acid Standard Kit is an in vitro diagnostic product intended forcalibration or calibration verification of clinical chemistry test systems.
The Electrolyte Standard Kit is an in vitro diagnostic product intended for calibration orcalibration verification of serum electrolyte test systems.
The Cholesterol Standard Kit is an in vitro diagnostic product intended for calibrationor calibration verification of clinical chemistry test systems.
The Uric Acid Standard Kit is an in vitro diagnostic product intended for calibration orcalibration verification of clinical chemistry test systems.
The ISE Standard Kit is an in vitro diagnostic product intended for calibration orcalibration verification of clinical chemistry test systems.
The ISE Standard (S4) is an in vitro diagnostic product intended for calibration orcalibration verification of clinical chemistry test systems.
The Multi-Chemistry Standard Kit is an in vitro diagnostic product intended forcalibration or calibration verification of clinical chemistry test systems :

Device Description

All calibrator materials included in this submission are aqueous, primary standards containing known amounts of each component for in vitro diagnostic use. Standardization is achieved by gravimetric procedure. Verification is performed using available NIST Standard Reference materials.

AI/ML Overview

The provided document is a 510(k) premarket notification for Verichem Laboratories Inc.'s diagnostic calibrators. It describes the properties and intended use of several calibrator kits, including Carbon Dioxide Standard Kit, Urine Chemistry Standard Kit, Urine Uric Acid Standard Kit, Electrolyte Standard Kit, Cholesterol Standard Kit, Uric Acid Standard Kit, ISE Standard Kit, ISE Standard (S4), and Multi-Chemistry Standard Kit.

This document is a regulatory submission for in vitro diagnostic calibrators, not for an AI/ML-based medical device. Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as they relate to AI/ML performance (e.g., sensitivity, specificity, reader studies, ground truth establishment by experts) are not applicable to this type of device.

Instead, the performance of these calibrators is based on analytical performance characteristics, primarily:

Precision/Reproducibility: Stated as typically <3.0% coefficient of variation.
Traceability: Achieved through the use of NIST Standard Reference Materials or equivalent primary standards.
Value Assignment: Determined by gravimetric procedures using standard source materials of known purity, verified against NIST materials.
Stability: Monitored through real-time stability studies, with acceptance criteria defined by Verichem's Quality Control End Test Procedure, using freshly prepared identical product as reference and including NIST material.

Therefore, I cannot provide the requested table or information regarding AI/ML-specific study design elements (e.g., sample size for test/training sets, expert consensus, MRMC studies, standalone performance, adjudication methods) because this document does not describe the validation of an AI/ML device.

The document's purpose is to demonstrate substantial equivalence to previously cleared predicate devices based on shared intended use, analytes, manufacturing methods (gravimetric), and analytical performance characteristics relevant to calibrators. The "study" here is primarily a demonstration of adherence to established quality control procedures and traceability standards for chemical calibrants.

Summary

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MAR 2 8 2012

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The assigned 510k number is: K112834

Manufacturer's Name, Address, Telephone, Contact Person and Date of Preparation:

Manufacturer:

Verichem Laboratories Inc. 90 Narragansett Avenue Providence, R.I. 02907

Contact Information:

Verichem Laboratories Inc. 90 Narragansett Avenue Providence, R.I. 02907

Attn: Anthony Di Monte Tel: 401-461-0180 Fax: 401-467-1540

Date prepared: September 22, 2011

Analytes:

Carbon Dioxide, Uric Acid, Cholesterol, Triglyceride, Sodium, Potassium, Chloride, Urea Nitrogen, Creatinine, Total Calcium, Phosphorous, Magnesium, Lithium, Ionized Calcium, · Lactate, Glucose.

Type of Test:

Calibrators

Proprietary and Established Names:

See table below under Indications for Use (G2) for proprietary names.

Regulatory Information:

1. Regulation section:
- 21 CFR§ 862.1150 Calibrator 7
1. Classification: Class II
1. Product Code:
JIX Calibrator, Multi-Analyte Mixture
1. Panel:

Clinical Chemistry (75)

Intended Use:

l . Intended use(s): See below.

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2. Indication(s) for use:

The nine Verichem Diagnostic standard solutions appear in the table below, along with their intended use. . .

Part Number	Product Name	Intended Use
9210	Carbon Dioxide Standard Kit	The Carbon Dioxide Standard Kit is an in vitro diagnostic product intended forcalibration or calibration verification of carbon dioxide test systems.
9000	Urine Chemistry Standard Kit	The Urine Chemistry Standard Kit is an in vitro diagnostic product intended forcalibration or calibration verification of clinical chemistry test systems.
9020	Urine Uric Acid Standard Kit	The Urine Uric Acid Standard Kit is an in vitro diagnostic product intended forcalibration or calibration verification of clinical chemistry test systems.
9200	Electrolyte Standard Kit	The Electrolyte Standard Kit is an in vitro diagnostic product intended for calibration orcalibration verification of serum electrolyte test systems.
9110	Cholesterol Standard Kit	The Cholesterol Standard Kit is an in vitro diagnostic product intended for calibrationor calibration verification of clinical chemistry test systems.
9010	Uric Acid Standard Kit	The Uric Acid Standard Kit is an in vitro diagnostic product intended for calibration orcalibration verification of clinical chemistry test systems.
9240	ISE Standard Kit	The ISE Standard Kit is an in vitro diagnostic product intended for calibration orcalibration verification of clinical chemistry test systems.
9207	ISE Standard (S4)	The ISE Standard (S4) is an in vitro diagnostic product intended for calibration orcalibration verification of clinical chemistry test systems.
9100	Multi-Chemistry Standard Kit	The Multi-Chemistry Standard Kit is an in vitro diagnostic product intended forcalibration or calibration verification of clinical chemistry test systems :

Special condition for use statement(s):

These devices are for in vitro diagnostic use.

Device Description:

Substantial Equivalence Information:

Predicate device name(s):

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#	Product Description	Predicate Device	510k	Cleared Date
1	Carbon Dioxide Standard Kit	pHoenix Diagnostics ISE Standards	K023268	November 15, 2002
2	Urine Chemistry Standard Kit	Multi-Chemistry Linearity Standard	K875285	Sept. 2,1988
3	Urine Uric Acid Standard Kit	Beckman - Synchron Multi-Calibrator	K110251	May 25, 2011
4	Electrolyte Standard Kit	pHoenix Diagnostics ISE Standards	K023268	November 15, 2002
5	Cholesterol Standard Kit	Beckman - Synchron Multi-Calibrator	K110251	May 25, 2011
6	Uric Acid Standard Kit	Beckman - Synchron Multi-Calibrator	K110251	May 25, 2011
7	ISE Standard Kit	pHoenix Diagnostics ISE Standards	K023268	November 15, 2002
8	ISE Standard (S4)	pHoenix Diagnostics ISE Standards	K023268	November 15, 2002
9	Multi-Chemistry Primary Standards	Multi-Chemistry Linearity Standard	K875285	Sept. 2,1988

Substantial Equivalence Table & Trade Names

1. Predicate K number(s): See the table in section I, 1, above.
1. Comparison with predicate:

See Exhibits 5 - 7: Comparative Information

Standard/Guidance Document Reference (if applicable):

FDA / CDRH: Abbreviated (510k) Submissions for In Vitro Diagnostic Calibrators: Final Guidance for Industry - Version 2011. Date: 02/22/1999

Test Principle:

Not applicable.

Performance Characteristics (if/when applicable):

l . Analytical performance:

a. Precision/Reproducibility:

The precision performance specifications are defined in the individual quality control test protocols. These are typically less than 3.0 % coefficient of variation. Precision performance for the lowest concentration set is based on resolution of the analyzer at that level.

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b. Linearity/assay reportable range: Not applicable.

c. Traceability (controls, calibrators, or method):

See each individual Comparative Information Table for the specific NIST Standard Reference materials used.

d. Methodology for Concentration Verification: Each product Certificate of Analysis includes a description of the methodology used to verify the gravimetric concentration. This document is included in each kit.

VALUE ASSIGNMENT:

Assigned concentrations are primary standard values. These standard values are assigned by gravimetric procedure and indicate weight per volume composition using standard source materials of known purity. The gravimetric concentrations are verified and lot certified using NIST Standard Reference materials or equivalent primary standards if NIST is not available. Reference method verification is used when available.

STABILITY:

Real time stability studies are conducted according to Verichem Standard Operating Procedure number 40. Acceptance criteria for multi-level components are identical to the Verichem Quality Control End Test Procedure. Our real time stability testing utilizes a freshly prepared identical product as a reference to determine change in analyte concentration over time. NIST material is included in the stability testing.

e. Detection limit: Not applicable.

f. Analytical specificity: Not applicable.

g. Assay cut-off: Not applicable.

Comparison studies:

a. Method comparison with predicate device: Not applicable.

b. Matrix comparison: Not applicable.

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1. Clinical studies: Not applicable.
1. Clinical cut-off: Not applicable.
1. Expected values/Reference range: See each individual product insert.

Conclusion: We have shown that these Verichem devices are similar to the predicate devices in terms of analytes, intended use, performance characteristics, value assignment, matrix and stability. I recommend that this device be found substantially equivalent in terms of safety and effectiveness to the predicate device(s).

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Image /page/5/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 an abstract symbol that resembles a stylized human figure.

10903 New Hampshire Avenue Silver Spring, MD 20993

Verichem Laboratories c/o Anthony James Dimonte 90 Narrangansett Avenue Providence, RI 02907 USA

MAR 2 8 2012

Re: K112834

Trade Name: ISE Standard Kit, Multi-Chemistry Standard Kit, Uric Acid Standard Kit, Urine Chemistry Standard Kit, Urine Uric Acid Standard Kit, Cholesterol Standard Kit, Carbon Dioxide Standard Kit, Electrolyte Standard Kit, ISE Standard (S4)

Regulation Number: 21 CFR §862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX Dated: March 16, 2012

Received: March 20, 2012

Dear Mr. Dimonte:

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical

Devices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance ...

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm

Sincerely yours.

Signature

Counney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name:

Indications for Use:

The Verichem ISE Standard Kit is intended for the calibration of sodium, potassium, chloride, lithium, ionized calcium and carbon dioxide assays performed on a number of clinical chemistry instrument systems. A complete list of instrument models are found in the package insert. For in vitro diagnostic use only.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

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

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

Rute Chen

510(k) 112834

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510(k) Number (if known):

Multi-Chemistry Standard Kit Device Name:

Indications for Use:

The Verichem Multi-Chemistry Standard Kit is intended for the calibration of sodium, potassium, lactate, chloride, glucose, urea nitrogen, creatinine, calcium, phosphorus, magnesium and triglyceride assays performed on a number of clinical chemistry instrument systems. A complete list of instrument models are found in the package insert. For in vitro diagnostic use only.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

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

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

510(k) 1 2 3 4

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510(k) Number (if known):

Device Name:

Indications for Use:

The Verichem Uric Acid Standard Kit is intended for the calibration of uric acid assays performed on a number of clinical chemistry instrument systems. A complete list of instrument models are found in the package insert. For in vitro diagnostic use only.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)

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

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

Rutte Charles

510(k) 112834

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510(k) Number (if known): _ _ K112834

Device Name:

Indications for Use:

The Verichem Urine Chemistry Standard Kit is intended for the calibration of sodium, potassium, chloride, urea nitrogen, creatinine, calcium, phosphorus and magnesium assays performed on a number of clinical chemistry instrument systems. A complete list of instrument models are found in the package insert. For in vitro diagnostic use only.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

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

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

Ruta Charles

510(k) 112834

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510(k) Number (if known):

Device Name:

Indications for Use:

The Verichem Urine Uric Acid Standard Kit is intended for the calibration of uric acid assays performed on a number of clinical chemistry instrument systems. A complete list of instrument models are found in the package insert. For in vitro diagnostic use only.

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

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

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

Rute Chilen

112834 510(k)

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510(k) Number (if known):

Device Name: Cholesterol Standard Kit

Indications for Use:

The Verichem Cholesterol Standard Kit is intended for the calibration of total cholesterol assays performed on a number of clinical chemistry instrument systems. A complete list of instrument models are found in the package insert. For in vitro diagnostic use only.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)

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

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

Page bof 1

Qute Chube

510(k) 112834

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510(k) Number (if known):

Device Name:

Indications for Use:

The Verichem Carbon Dioxide Standard Kit is intended for the calibration of carbon dioxide assays performed on a number of clinical chemistry instrument systems. A complete list of instrument models are found in the package insert. For in vitro diagnostic use only.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)

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

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

Page Tof ___

land of the first of the first of the first of the first of the first of the first of the first for the first for the first for the first for the first for the first for the

510(k) 112834

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510(k) Number (if known):

Device Name: Electrolyte Standard Kit

Indications for Use:

The Verichem Electrolyte Standard Kit is intended for the calibration of sodium, potassium, lithium, chloride and ionized calcium assays performed on a number of clinical chemistry instrument systems. A complete list of instrument models are found in the package insert. For in vitro diagnostic use only.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

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

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

Rute Chisholm

Division Sian-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) 112834

Paged of 4

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510(k) Number (if known): _ K112834

Device Name:

Indications for Use:

The Verichem ISE Standard (S4) is intended for the calibration of sodium, potassium, chloride and carbon dioxide assays performed on a number of clinical chemistry instrument systems. A complete list of instrument models are found in the package insert. For in vitro diagnostic use only.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

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

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

Rute Chase

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) 112834

Page 9 of 9

Regulation Number and Section

§ 862.1150 Calibrator.

(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special 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.