(132 days)
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.
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.
This document describes the performance testing of the Poly-Chem 90 Total Bilirubin device, a reagent/test system for quantitative in vitro measurement of total bilirubin in human serum.
Here's an analysis of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Characteristic | Acceptance Criteria (from context, implicit) | Reported Device Performance (Poly-Chem 90 Total Bilirubin) |
|---|---|---|
| Precision (Intraassay %CV) | Lower is better (compared to predicate) | 0.23% to 1.65% (samples from 0.50 to 25.71 mg/dL) |
| Precision (Interassay %CV) | Lower is better (compared to predicate) | 4.29% to 5.40% (samples from 0.50 to 25.71 mg/dL) |
| Measuring Range (Linearity) | Comparable or improved to predicate | 0.07 - 27.5 mg/dL |
| Sensitivity (Limit of Quantitation) | Lower is better (not explicitly stated, but generally desired) | 0.08 mg/dL (10% CV) |
| Interference (Hemoglobin) | Acceptable level (no significant interference) | 600 mg/dL (highest level tested with no interference) |
| Interference (Triglyceride) | Acceptable level (no significant interference) | 554 mg/dL (highest level tested with no interference) |
| Method Comparison (Slope vs. Predicate) | Close to 1.0 (indicating agreement) | 0.98 (95% CI: 0.98 to 0.99) |
| Method Comparison (Intercept vs. Predicate) | Close to 0.0 (indicating agreement) | -0.03 (95% CI: -0.04 to -0.01) |
| Method Comparison (Correlation Coefficient, r) | Close to 1.0 (indicating strong correlation) | 0.9998 |
Note on Acceptance Criteria: The document implies that the acceptance criteria are met by demonstrating "substantial equivalence" to the predicate device (Poly-Chem Total Bilirubin, K973995). Therefore, the reported device performance is compared to the predicate's performance to establish this equivalence. While specific numerical acceptance criteria are not explicitly listed as pass/fail thresholds, the statistical results (e.g., correlation coefficient, confidence intervals for slope and intercept) are used to support the claim of substantial equivalence.
2. Sample Sizes used for the test set and the data provenance:
- Precision: No explicit sample size is given for the precision runs beyond "Sample 1", "Sample 2", "Sample 3" across two instruments. Each "sample" likely represents multiple replicates over several days to determine within-run and between-run variability. The values presented are means, SDs, and CVs, implying multiple measurements. The origin is not specified, but it's likely from internal lab testing given the nature of a 510(k) submission for a diagnostic reagent.
- Linearity, Sensitivity, Interference: No specific sample sizes are given, but these are typically determined through laboratory experiments using controlled samples.
- Method Comparison: 82 samples were used for comparison with the predicate device.
- Data Provenance: Not explicitly stated, but given it's a 510(k) submission for an in vitro diagnostic, this data would be from controlled laboratory studies, likely using human serum samples. The country of origin is not specified, but the manufacturer is based in the United Kingdom. It is a prospective study as it involves new testing of the Poly-Chem 90 and comparison to an existing device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable to this type of device and study. This is an in vitro diagnostic (IVD) reagent for measuring a quantitative analyte (Total Bilirubin). The "ground truth" for method comparison and performance characteristics is established by a reference method or the predicate device itself, not by expert interpretation of images or clinical cases.
4. Adjudication method for the test set:
Not applicable. As an IVD for quantitative measurement, there is no need for expert adjudication. The comparison is against established laboratory methods or a predicate device.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is a chemical reagent and instrument system, not an AI-assisted diagnostic imaging tool that involves human readers interpreting cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, in essence. This device inherently operates in a "standalone" manner. The Poly-Chem 90 analyzer, using the Poly-Chem 90 Total Bilirubin reagent, provides a quantitative measurement directly. There isn't a "human-in-the-loop" interpretation step in the same way as with an imaging AI system. The performance characteristics (precision, linearity, sensitivity, comparison to predicate) are all measures of the algorithm/reagent's accuracy and reliability in providing the numerical result.
7. The type of ground truth used:
- Method Comparison: The "ground truth" for the method comparison study was established by the predicate device, Poly-Chem Total Bilirubin (K973995). The results from the new device (Poly-Chem 90) were compared to the results obtained from the predicate device on the same samples.
- Other performance metrics (Precision, Linearity, Sensitivity, Interference): These are inherent performance characteristics determined against established laboratory practices and analytical standards. For example, linearity is assessed by testing known concentrations, and sensitivity by calculating limits of detection/quantitation based on statistical methods from repeated measurements of low-concentration samples.
8. The sample size for the training set:
Not applicable. This device is a chemical reagent-based diagnostic system, not an AI/machine learning model that requires a "training set." The performance is characterized through traditional analytical validation methods.
9. How the ground truth for the training set was established:
Not applicable. As stated above, there is no "training set" for this type of device.
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YMEDCO inc. Corporate Office
K11143 510 Furnace Dock Road, Cortlandt Manor, NY 10567
Tel: 800.431.2123 FAX 914.739.5890 Seattle Office 9750 Third Ave NE Ste. 100, Seattle, WA 98115 Tel: 206.402.6146
FAX: 206.659.4956
510(k) Summary
SEP - 1 2011
Address: Polymedco, Inc. 510 Furnace Dock Road Cortlandt Manor, NY 10567
Helen Landicho
Phone: (206) 402-6146 (206) 659-4956 (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
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POLYMEDCO inc. Corporate Office
510 Furnace Dock Road, Cortlandt Manor, NY 10567 Tel: 800.431.2123 FAX 914.739.5890
| Seattle Office | 9750 Third Ave NE Ste. 100, Seattle, WA 98115 |
|---|---|
| Tel: 206.402.6146FAX: 206.659.4956 |
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 vitromeasurement of the level of totalbilirubin in human serum on thePoly-Chem 90 analyzer. | For the quantitative in vitromeasurement of the level of totalbilirubin in human serum andplasma on the Poly-Chemanalyzer. |
| Indications for Use | Measurements of the level ofbilirubin, an organic compoundformed during the normal andabnormal destruction of red bloodcells, are used in the diagnosisand treatment of liver, hemolytichematological, and metabolicdisorders, including hepatitis andgall 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 withPredicate | $y = 0.98x - 0.03, r = 0.9998$ ; 82samples from 0.10 - 24.10 mg/dL | $y = 0.93x + 0.02, r = 0.98$ ; 33samples 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 |
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OLYMEDCO inc. Corporate Office
510 Furnace Dock Road, Cortlandt Manor, NY 10567 Tel: 800.431.2123 FAX 914.739.5890
Seattle Office 9750 Third Ave NE Ste. 100, Seattle, WA 98115 Tel: 206.402.6146 FAX: 206.659.4956
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 (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 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 (800) 638-2041 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
§ 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.