POLY-CHEM 90 TOTAL BILIRUBIN

• K Number: K111143
• Device Name: POLY-CHEM 90 TOTAL BILIRUBIN
• Manufacturer: POLYMEDCO, INC.
• Date Cleared: 2011-09-01 ( 132 days)
• Product Code: CIG DAT REG
• Regulation Number: 862.1110

Intended Use

Poly-Chem 90 Total Bilirubin is for the quantitative in vitro measurement of the level of total bilirubin in human serum on the Poly-Chem 90 clinical chemistry analyzer. Measurements of the level of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, are used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.

Device Description

Poly-Chem 90 Total Bilirubin is for the quantitative in vitro measurement of the level of total bilirubin in human serum on the Poly-Chem 90 clinical chemistry analyzer. The test methodology is a colorimetric method based on that described by Jendrassik and Grof (1938). Total bilirubin is determined in the presence of caffeine, which releases albumin bound bilirubin, by the reaction with diazotized sulphanilic acid.

Predicate Devices

K973995

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard colorimetric chemical assay for measuring bilirubin and does not mention any AI or ML components.

Therapeutic

No
The device is for in vitro diagnostic measurement of total bilirubin, which is used in the diagnosis and treatment of conditions, but it does not directly provide therapy.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that measurements of bilirubin levels "are used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block." This indicates a diagnostic purpose.

SaMD (Software as a Medical Device)

No

The device is a reagent for an in vitro diagnostic (IVD) test, which is a chemical substance used in a laboratory setting, not a software-only medical device.

IVD (In Vitro Diagnostic)

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

Here's why:

• Intended Use/Indications for Use: The description explicitly states "for the quantitative in vitro measurement of the level of total bilirubin in human serum". The term "in vitro" is a key indicator of an IVD. It also mentions the use of these measurements in the diagnosis and treatment of various disorders, which is a typical purpose of IVDs.
• Device Description: The description reiterates that it is for "quantitative in vitro measurement" and describes a laboratory-based chemical reaction ("colorimetric method based on that described by Jendrassik and Grof"). This further confirms its nature as an IVD.
• Performance Studies: The performance studies described (precision, linearity, sensitivity, interferences, method comparison) are standard types of studies conducted for IVD devices to demonstrate their analytical performance.
• Predicate Device: The mention of a "Predicate Device" with a K number (K973995) is also a strong indicator that this device is being submitted for regulatory clearance as an IVD, as predicate devices are used for demonstrating substantial equivalence in the IVD regulatory pathway.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Poly-Chem 90 Total Bilirubin is for the quantitative in vitro measurement of the level of total bilirubin in human serum on the Poly-Chem 90 clinical chemistry analyzer. Measurements of the level of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, are used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.

Product codes

CIG

Device Description

Poly-Chem 90 Total Bilirubin is for the quantitative in vitro measurement of the level of total bilirubin in human serum on the Poly-Chem 90 clinical chemistry analyzer. The test methodology is a colorimetric method based on that described by Jendrassik and Grof (1938). Total bilirubin is determined in the presence of caffeine, which releases albumin bound bilirubin, by the reaction with diazotized sulphanilic acid.

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)

To demonstrate substantial equivalence, performance characteristics that were tested included precision, linearity, sensitivity, interferences, and method comparison. Results of this testing are summarized below. The results indicate that Poly-Chem 90 Total Bilirubin is substantially equivalent to currently marketed Total Bilirubin reagent test systems.

Precision

Sample	Instrument	Mean	SD	CV	SD	CV
1	1	0.50	0.008	1.65	0.027	5.40
1	2	0.50	0.006	1.19	0.025	5.10
2	1	5.02	0.021	0.42	0.215	4.29
2	2	4.98	0.032	0.65	0.225	4.51
3	1	25.71	0.059	0.23	1.270	4.94
3	2	25.42	0.249	0.98	1.336	5.26

Linearity

0.07 – 27.5 mg/dL

Sensitivity

• Limit of Blank: 0.0043 mg/dL
• Limit of Detection: 0.0184 mg/dL
• Limit of Quantitation (10% CV): 0.08 mg/dL

Interference

Highest level tested with no interference: Hemoglobin 600 mg/dL, Triglyceride 554 mg/dL

Comparison with predicate device

• n: 82
• Range of samples: 0.10 - 24.10
• Slope (95% CI): 0.98 (0.98 to 0.99)
• Intercept (95% CI): -0.03 (-0.04 to -0.01)
• r: 0.9998

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

See "Summary of Performance Studies" for Sensitivity, Linearity, and Precision data.

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.

K973995

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

§ 862.1110 Bilirubin (total or direct) test system.

(a)
Identification. A bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.(b)
Classification. Class II.

Summary

0

YMEDCO inc. Corporate Office

K11143 510 Furnace Dock Road, Cortlandt Manor, NY 10567

Tel: [phone] FAX [phone] Seattle Office 9750 Third Ave NE Ste. 100, Seattle, WA 98115 Tel: [phone]

FAX: [phone]

510(k) Summary

SEP - 1 2011

Address: Polymedco, Inc. 510 Furnace Dock Road Cortlandt Manor, NY 10567

Helen Landicho

Phone: [phone] [phone] (fax)

Summary prepared July 14, 2011

Contact Person:

510(k) number:	K111143
Name of the device:	Poly-Chem® 90 Total Bilirubin
Device common name:	Total Bilirubin reagent/test system
Product code:	CIG
Regulation number:	862.1110
Classification:	Class II
Predicate Device:	Poly-Chem® Total Bilirubin
Device common name:	Total Bilirubin reagent/test system
510(k) number:	K973995
Manufacturer:	Randox Laboratories Ltd.,
55 Diamond Road, Crumlin,
Co. Antrim, United Kingdom

BT29 4QY

862.1110

Class II

CIG

Product code: Regulation number: Classification:

Poly-Chem 90 Total Bilirubin is for the quantitative in vitro Device Description: measurement of the level of total bilirubin in human serum on the Poly-Chem 90 clinical chemistry analyzer. The test methodology is a colorimetric method based on that described by Jendrassik and Grof (1938). Total bilirubin is determined in the presence of caffeine, which releases albumin bound bilirubin, by the reaction with diazotized sulphanilic acid.

Poly-Chem 90 Total Bilirubin is for the quantitative in vitro Intended use: measurement of the level of total bilirubin in human serum on the Poly-Chem 90 clinical chemistry analyzer. Measurements of the level

1

POLYMEDCO inc. Corporate Office

510 Furnace Dock Road, Cortlandt Manor, NY 10567 Tel: [phone] FAX [phone]

Seattle Office	9750 Third Ave NE Ste. 100, Seattle, WA 98115
	Tel: [phone]
FAX: [phone]

of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, are used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders. including hepatitis and gall bladder block.

Similarities and Differences with Predicate Device

Similarities and Differences Total Bilirubin
Item	Poly-Chem 90 Total Bilirubin	Poly-Chem Total Bilirubin
Intended Use	For the quantitative in vitro
measurement of the level of total
bilirubin in human serum on the
Poly-Chem 90 analyzer.	For the quantitative in vitro
measurement of the level of total
bilirubin in human serum and
plasma on the Poly-Chem
analyzer.
Indications for Use	Measurements of the level of
bilirubin, an organic compound
formed during the normal and
abnormal destruction of red blood
cells, are used in the diagnosis
and treatment of liver, hemolytic
hematological, and metabolic
disorders, including hepatitis and
gall bladder block.	Same
Sample type	Serum	Serum and plasma
Test methodology	Colorimetric	Same
Precision	Intraassay: %CV from 0.4% to 1.7%
Interassay: %CV from 4.3% to 5.4%
Samples from 0.50 to 25.71 g/dL	Intraassay: %CV from 2.1% to 2.3%
Interassay: %CV from 1.4% to 1.9%
Samples from 0.92 to 5.29 mg/dL
Measuring range	0.1-27.5 mg/dL	0.09 - 25 mg/dL
Comparison with
Predicate	$y = 0.98x - 0.03, r = 0.9998$ ; 82
samples from 0.10 - 24.10 mg/dL	$y = 0.93x + 0.02, r = 0.98$ ; 33
samples from 0.09 – 4.86 mg/dL
Storage	15 - 25°C	Same
Stability	Same	Same
Expected values	Adults: up to 1 mg/dl (17 µmol/l)	Same
Reagent Kit	Same	Same
Analyzer	Poly-Chem 90	Poly-Chem 180

2

OLYMEDCO inc. Corporate Office

510 Furnace Dock Road, Cortlandt Manor, NY 10567 Tel: [phone] FAX [phone]

Seattle Office 9750 Third Ave NE Ste. 100, Seattle, WA 98115 Tel: [phone] FAX: [phone]

Summary of performance testing

To demonstrate substantial equivalence, performance characteristics that were tested included precision, linearity, sensitivity, interferences, and method comparison. Results of this testing are summarized below. The results indicate that Poly-Chem 90 Total Bilirubin is substantially equivalent to currently marketed Total Bilirubin reagent test systems.

Precision

			Within run		Between run
Sample	Instrument	Mean	SD	CV	SD	CV
1	1	0.50	0.008	1.65	0.027	5.40
1	2	0.50	0.006	1.19	0.025	5.10
2	1	5.02	0.021	0.42	0.215	4.29
2	2	4.98	0.032	0.65	0.225	4.51
3	1	25.71	0.059	0.23	1.270	4.94
3	2	25.42	0.249	0.98	1.336	5.26

Linearity of the test 0:07 – 27.5 mg/dL

Sensitivity

| Limit of Blank | Limit of Detection | Limit of Quantitation
(10% CV) |
|----------------|--------------------|-----------------------------------|
| 0.0043 mg/dL | 0.0184 mg/dL | 0.08 mg/dL |

Interference

Highest level tested with no interference: Hemoglobin 600 mg/dL Triglyceride 554 mg/dL

Comparison with predicate device

| n | Range of samples | Slope
(95% CI) | Intercept
(95% CI) | r |
|----|------------------|------------------------|---------------------------|--------|
| 82 | 0.10 - 24.10 | 0.98
(0.98 to 0.99) | -0.03
(-0.04 to -0.01) | 0.9998 |

Conclusions

Poly-Chem 90 Total Bilirubin is substantially equivalent to currently marketed Total Bilirubin reagent test systems.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Polymedco. Inc c/o Helen Landicho, RAC Vice President, Regulatory Affairs 510 Furnace Dock Rd Cortlandt Manor . New York. 10567 Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

SEP 0 1 2011

Re: K11143 Trade name: Regulation Number: Regulation Name: Regulatory Class: Product Codes: Dated: Received:

Poly-Chem ® 90 Total Bilirubin 21CFR $862.1110 Total Bilirubin test system Class II CIG August 18, 2011 August 22, 2011

Dear Ms. Landicho.

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 Virro Diagnostic Device Evaluation and Safety at [phone]. 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 [phone]. For questions regarding of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/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 [phone] or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm.

Sincerely yours,

signature

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

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510(k) Number (if known):

Device Name: Poly-Chem 90 Total Bilirubin test

Indications For Use:

Poly-Chem 90 Total Bilirubin is for the quantitative in vitro measurement of the level of total bilirubin in human serum on the Poly-Chem 90 clinical chemistry analyzer. Measurements of the level of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.

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)

Signature

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) 111143