Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a chemical reagent set for measuring carbon dioxide levels and the performance studies are based on standard analytical chemistry methods, not AI/ML algorithms.

Therapeutic

No.
This device is an in vitro diagnostic reagent set designed to measure carbon dioxide levels in human serum, providing information for the assessment of acid-base balance. It does not directly treat or alleviate a disease, but rather provides diagnostic information.

Diagnostic

Yes

Explanation: The "Intended Use" clearly states that the device is "intended for measurement of Carbon Dioxide level in human serum" and that "Test results may provide information regarding the status in the assessment of acid-base balance of metabolic alkalosis or respiratory acidosis." This indicates that the device is used to measure a physiological parameter (carbon dioxide levels) to provide information for diagnosing or assessing a medical condition (acid-base imbalances).

SaMD (Software as a Medical Device)

No

The device is a reagent set, which is a chemical product used in laboratory tests, not a software-only device. The description details the chemical components and performance studies related to the reagent's analytical properties.

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: "Teco Carbon Dioxide Reagent Set is a device which is intended for measurement of Carbon Dioxide level in human serum, in vitro diagnostic use only."
Device Description: The description details a reagent kit used to measure a substance (carbon dioxide/bicarbonate) in a biological sample (human serum) outside of the body.
Intended User / Care Setting: It specifies "This is an in vitro diagnostic test for professional use only."

These points clearly indicate that the device is designed and intended for diagnostic testing performed on samples taken from the human body, but outside of the body, which is the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Teco Carbon Dioxide Reagent Set is a device which is intended for measurement of Carbon Dioxide level in human serum, in vitro diagnostic use only. Test results may provide information regarding the status in the assessment of acid-base balance of metabolic alkalosis or respiratory acidosis.

Product codes

KHS

Device Description

Teco Carbon Dioxide Reagent Set is a single reagent kit. Reagent contains Good's buffer, phosphoenolpyruvate (PEP), phosphoenolpyruvate carboxylase (PEPC), malate dehydrogenase (MDH), magnesium ions, NADH analog, nonreactive stabilizer, preservative, and Buffer. Approximately 90% of carbon dioxide present in serum is in the form of bicarbonate. The measurement of bicarbonate is useful in the assessment of disturbances of acid-base balance resulting from metabolic or respiratory causes.

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

This is an in vitro diagnostic test for professional use only.

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

Analytical Performance: Precision/Reproducibility
- Study Type: Precision/Reproducibility study in accordance with CLSI EP5-A2 guideline.
- Sample Size: Not explicitly stated, but samples were tested in duplicate, 2 lots, and 2 runs per day for 20 days.
- Data Source: Unaltered human serums spiked with carbon dioxide concentrations and commercial serum based controls.
- Key Results:
  - QC Level 1 (Mean 30.6 mmol/L): Repeatability SD 0.1782, %CV 0.582; Within-Laboratory Precision SD 1.62, %CV 5.31
  - QC Level 2 (Mean 20.5 mmol/L): Repeatability SD 0.7065, %CV 3.426; Within-Laboratory Precision SD 1.87, %CV 9.07
  - Serum Level 1 (Mean 12.0 mmol/L): Repeatability SD 0.1275, %CV 1.065; Within-Laboratory Precision SD 0.69, %CV 5.75
  - Serum Level 2 (Mean 26.6 mmol/L): Repeatability SD 0.1521, %CV 0.571; Within-Laboratory Precision SD 0.85, %CV 3.21
  - Serum Level 3 (Mean 37.4 mmol/L): Repeatability SD 0.1949, %CV 0.521; Within-Laboratory Precision SD 0.59, %CV 1.58
Analytical Performance: Linearity/Assay Reportable Range
- Study Type: Linearity study in accordance with CLSI EP6-A.
- Sample Size: 11 different concentrations across two lots of reagent. Each sample assay tested in 3 replicates.
- Data Source: Unaltered human serum samples prepared by mixing a diluted patient serum sample (2 mmol/L) and a spiked patient serum sample (64 mmol/L).
- Key Results: The assay is linear up to 64 mmol/L. Linear regression: y= 1.0192x + 0.0351; R2=0.9993. Reportable range: 8.7 - 40.0 mmol/L.
Analytical Performance: Detection Limit
- Study Type: Detection limit studies (LoB, LoD, LoQ) in accordance with CLSI EP17-A2 guideline.
- Sample Size: Four (4) samples for LoB and LoD studies, tested in five (5) replicates over 3 days. Five (5) samples for LoQ study, tested in three (3) replicates over 3 days.
- Data Source: LoD pools consisted of 4 separate pools, and LoQ pools consisted of 5 separate pools near the current bottom of the serum assay ranges. 9 LoD / LoQ serum pools prepared by diluting patient serum with artificial serum. LoB pool consisted of artificial serum base matrix with no carbon dioxide added.
- Key Results: LoB = 0.92 mmol/L, LoD = 1.5 mmol/L, LoQ = 1.77 mmol/L.
Analytical Performance: Analytical Specificity
- Study Type: Interference studies in accordance with CLSI EP7-A2 guideline.
- Sample Size: Two (2) different concentrations of sodium bicarbonate (20 mmol/L and 35 mmol/L) human serum samples. Pooled human serum samples with added potential interferents tested in replicates of ten (10).
- Data Source: Pooled human serum samples with added potential interferents (bilirubin (Total and Conjugated), hemoglobin, triglyceride, ascorbic acid, and intralipid).
- Key Results: No significant bias (defined as ±10% difference from the control results) observed for:
  - Hemoglobin up to 1,000 mg/dL
  - Total Bilirubin up to 60 mg/dL
  - Conjugate Bilirubin up to 30 mg/dL
  - Triglycerides up to 2,000 mg/dL
  - Intralipid up to 2,000 mg/dL
  - Ascorbic Acid up to 6 mg/dL
Comparison Studies: Method Comparison
- Study Type: Serum CO2 correlation determination.
- Sample Size: 176 patient serum samples.
- Data Source: Patient serum samples ranging from 8.7 to 37.2 mmol/L of CO2.
- Key Results: Comparison between Pointe Scientific Inc. Carbon Dioxide Reagent (X) and Teco Carbon Dioxide Reagent Set (Y). Linear regression: y = 0.9785x + 0.2636 mmol/L, R^2 = 0.9925 and R = 0.9962.

Key Metrics

Precision/Reproducibility: SD, %CV
Linearity: R^2, R
Detection Limits: LoB, LoD, LoQ
Analytical Specificity: % difference from control results, concentration at which no significant interference was observed.
Method Comparison: Regression equation (y = 0.9785x + 0.2636), R^2 (0.9925), R (0.9962).

Predicate Device(s)

K070251

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 862.1160 Bicarbonate/carbon dioxide test system.

(a)
Identification. A bicarbonate/carbon dioxide test system is a device intended to measure bicarbonate/carbon dioxide in plasma, serum, and whole blood. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.(b)
Classification. Class II.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus consists of a staff with two snakes coiled around it, topped by a pair of wings.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 1, 2017

TECO DIAGNOSTICS, INC. HYUN BIN SONG RESEARCH SCIENTIST 1268 NORTH LAKEVIEW AVENUE ANAHEIM CA 92807

Re: K170200

Trade/Device Name: Carbon Dioxide Reagent Set Regulation Number: 21 CFR 862.1160 Regulation Name: Bicarbonate/carbon dioxide test system Regulatory Class: II Product Code: KHS Dated: April 26, 2017 Received: April 27, 2017

Dear Hyun Bin Song:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

1

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kellie B. Kelm -S

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

Enclosure

2

Form Approved: OMB No.	0910-0120
Expiration Date:	January 31, 2017
See PRA Statement below.

510(k) Number (if known)	K170200
Device Name	Carbon Dioxide Reagent Set
Indications for Use (Describe)	Teco Carbon Dioxide Reagent Set is a device which is intended for measurement of Carbon Dioxide level in human serum, in vitro diagnostic use only. Test results may provide information regarding the status in the assessment of acid-base balance of metabolic alkalosis or respiratory acidosis.

Type of Use (Select one or both, as applicable)

\ Prescription Use (Part 21 CFR 801 Subpart D)	□ Over-The-Counter Use (21 CFR 801 Subpart C)
-------------------------------------------------------------------------------------------------	------------------------------------------------------------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services

Food and Drug Administration

Office of Chief Information Officer

Paperwork Reduction Act (PRA) Staff

PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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1268 N. Lakeview Ave., Anaheim, CA 92807, U.S.A. Phone: (714) 463-1111 Toll Free: 1-800-222-9880 Fax: (714) 463-1169 www.tecodiag.com

Section 5 - 510(k) SUMMARY

This Summary of 510(k) Safety and Effectiveness is being submitted in accordance with the requirements of 21 CFR § 807.92.

Owner's Name: Teco Diagnostics, Inc.

Address and Contact information:

1268 North Lakeview Avenue Anaheim, CA 92807 Phone: 714-463-1111 Fax: 714-463-1169

Contact:

Hyun Bin Song

Date Prepared:

January 20, 2017

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Image /page/4/Picture/1 description: The image shows a green hexagon with the letters 'TC' in silver. The letters are stacked on top of each other, with 'T' on top and 'C' on the bottom. The letters are slightly offset to the left. The background of the hexagon is a solid green color.

1268 N. Lakeview Ave., Anaheim, CA 92807, U.S.A. Phone: (714) 463-1111 Toll Free: 1-800-222-9880 Fax: (714) 463-1169 www.tecodiag.com

Section 5 - 510(k) SUMMARY

A. 510(k) Number:

K170200

B. Analytes:

Carbon Dioxide

C. Type of Test:

Enzymatic, quantitative assay

D. Applicant:

Teco Diagnostics, Inc.

E. Trade Name:

Carbon Dioxide Reagent Set

F. Common Name:

Enzymatic Method, Carbon Dioxide

G. Regulatory Information:

1. Regulation Classification section:
  Class II; 21 CFR § 862.1160-Bicarbonate/carbon dioxide test system
1. Product Code:
  KHS
1. Panel:
  75, Clinical Chemistry

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Image /page/5/Picture/1 description: The image is a logo with a green hexagon as the background. Inside the hexagon are the letters 'TC' in a silver, metallic-like font. The letters are large and centered within the hexagon, making them the focal point of the logo. The overall design is simple, modern, and professional.

H. Intended Use:

1. Intended used:

See Indications for Use below.

2. Indication(s) for Use:

Teco Carbon Dioxide Reagent Set is a device which is intended for measurement of Carbon Dioxide level in human serum, in vitro use only. Test results may provide information regarding the status in the assessment of acid-base balance of metabolic alkalosis or respiratory acidosis.

3. Special conditions for use statement(s):

This is an in vitro diagnostic test for professional use only.

4. Special instrument requirements:

Not applicable

I. Device Description

Teco Carbon Dioxide Reagent Set is a single reagent kit. Reagent contains Good's buffer, phosphoenolpyruvate (PEP), phosphoenolpyruvate carboxylase (PEPC), malate dehydrogenase (MDH), magnesium ions, NADH analog, nonreactive stabilizer, preservative, and Buffer. Approximately 90% of carbon dioxide present in serum is in the form of bicarbonate. The measurement of bicarbonate is useful in the assessment of disturbances of acid-base balance resulting from metabolic or respiratory causes.

J. Substantial Equivalence Information:

1. Predicate device name(s): Pointe Scientific Inc., Carbon Dioxide Liquid Stable Reagent
1. Predicate K number(s): K070251
1. Compare with predicate:

Table 5.1 Teco Carbon Dioxide Reagent Set vs Pointe Scientific Inc., Carbon Dioxide Liquid Stable Reagent

| | Teco Carbon Dioxide Reagent Set
(Proposed Device) | Pointe Scientific Inc.,
Carbon Dioxide Liquid
Stable Reagent (Predicate
Device) |
|--------------|------------------------------------------------------|------------------------------------------------------------------------------------------|
| Manufacturer | Teco Diagnostics | Pointe Scientific Inc. |

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Image /page/6/Picture/1 description: The image shows a green hexagon with the letters "TC" in silver inside. The letters are stacked on top of each other, with "T" on top and "C" on the bottom. The hexagon has a slight gradient, with the top being slightly lighter than the bottom. The letters also have a gradient, with the top being slightly lighter than the bottom.

1268 N. Lakeview Ave., Anaheim, CA 92807, U.S.A. Phone: (714) 463-1111 Toll Free: 1-800-222-9880 Fax: (714) 463-1169 www.tecodiag.com

Section 5 - 510(k) SUMMARY

| Intended Use | This product is to be used for the
quantitative determination of
carbon dioxide in human serum
by spectrophotometric analysis.
For in vitro diagnostic use only. | Same |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Measured Parameters | Bicarbonate | Same |
| Intended Specimen | Serum | Same |
| Test Methodology | Enzymatic; malate dehydrogenase
and phosphoenolpyruvate
carboxylase | Same |
| Instrument Mode | Automatic Instrument | Same |
| Linearity | Serum: 8.7 to 40.0 mmol/L | Serum: 2.0 to 40.0 mmol/L |
| Wavelength | 405 nm | Same |
| Interferences | No interference was observed by
conjugated bilirubin up to 30
mg/dL, total bilirubin up to 60
mg/dL, hemoglobin up to 1,000
mg/dL, triglycerides up to 2,000
mg/dL, ascorbic acid up to
6mg/dL, and intralipid up to 2,000
mg/dL. | No interference was
observed by bilirubin up to
20.0 mg/dL, hemoglobin
up to 400 mg/dL and
lipemia (intralipid) up to
1,000 mg/dL. |
| Accuracy/Correlation
(Serum) | $y = 0.9785x + 0.2636$ ,
$R^2 = 0.9925$ and $R = 0.9962$ | $y = 0.965x + 1.200$ |
| Detection Limit
(LoQ) | 1.77 mmol/L (LoQ) | 2.0 mmol/L |
| Storage Temperature | 2-8 °C | Same |

Teco Carbon Dioxide Reagent Set and the Pointe Scientific Carbon Dioxide Liquid Stable Reagent share the same technological characteristics including the testing parameters, test methodology, and storage.

K. Standard/Guidance Document Referred (if applicable):

CLSI EP5-A3, Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline Third Edition.
CLSI EP6-A, Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guidelines.
CLSI EP7-A2, Interference Testing in Clinical Chemistry; Approved Guideline Second Edition.

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CLSI EP9-A3, Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline Third edition.
CLSI EP17-A2, Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures: Approve Guideline Second Edition.
CLSI EP25-A. Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline.

L. Test Principle:

The carbon dioxide in the human serum or serum based control sample reacts with phosphoenolpyruvate (PEP) in the presence of phosphoenolpyruvate carboxylase (PEPC) and magnesium to yield oxaloacetic acid (OAA) and phosphate. In the second reaction, in the presence of malate dehydrogenase (MDH), the reduced cofactor is oxidized by OAA. The reduced cofactor absorbs strongly at 405 nm, whereas its oxidized form does not. The difference in absorbance between the final reading and the blank, which is monitored at 405 nm/415 nm, is directly proportional to the total carbon dioxide concentration in the sample.

M. Performance Characteristics:

1. Analytical performance:

a. Precision/Reproducibility:
In the accordance with CLSI EP5-A2 guideline, samples were tested in duplicate, 2 lots, and 2 runs per day for 20 days. The samples were unaltered human serums that were spiked with carbon dioxide concentrations and commercial serum based controls. The results were tabulated, and the data was analyzed for means, standard deviations (SDs), and percent coefficients of variation (%CVs). The precision result from one lot is summarized below.

| | Mean
(mmol/L) | Repeatability | | Within-Laboratory Precision | |
|---------------|------------------|---------------|-------|-----------------------------|------|
| Sample | | SD | %CV | SD | %CV |
| QC Level 1 | 30.6 | 0.1782 | 0.582 | 1.62 | 5.31 |
| QC Level 2 | 20.5 | 0.7065 | 3.426 | 1.87 | 9.07 |
| Serum Level 1 | 12.0 | 0.1275 | 1.065 | 0.69 | 5.75 |
| Serum Level 2 | 26.6 | 0.1521 | 0.571 | 0.85 | 3.21 |
| Serum Level 3 | 37.4 | 0.1949 | 0.521 | 0.59 | 1.58 |

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b. Linearity/assay reportable range:
Linearity studies of Teco Carbon Dioxide Reagent Set were performed in accordance with the guidelines set forth in CLSI EP6-A. Linearity was tested using two lots of reagent with unaltered human serum samples. The samples were prepared by mixing a diluted patient serum sample (2 mmol/L) and a spiked patient serum sample (64 mmol/L) in order to obtain 11 different concentrations. Each sample assay was tested in 3 replicates using TC-MATRIX analyzer. The reagent revealed that the assay is linear up to 64 mmol/L. The linearity of Carbon Dioxide (Enzymatic) was analyzed over a measured range from 8.70 to 40.0 mmol/L. As a result, the linear regression analyses were obtained as below:

y= 1.0192x + 0.0351; R2=0.9993

The reportable range of the CO2 assay is 8.7 - 40.0 mmol/L

c. Traceability, Stability, Expected values (controls, calibrators, or methods): The CO2 method is traceable to NIST SRM 351. The CO2 assay is calibrated by comparing the change in absorbance of the unknown sample to the change in absorbance of the 30 mEq/L CO2 standard (from Integrated Diagnostics Group). The CO2 standard was previously cleared under K936245.
It is recommended using an aqueous CO2 standard (30 mmol/L) or an appropriate serum calibrator. To monitor the reliability of results, it is recommended using two levels of control sera with known CO2 values to be run along with patient sample.

The stability claim was verified using an accelerated stability protocol. Accelerated stability of the CO2 reagent was determined based on Arrehnius Model equation. Based on the study, accelerated stability of the CO2 reagent was demonstrated to be at least 21 months if the CO2 reagent is tightly capped and stored at 2-8°C. Reagents in unopened vials are stable at 2-8°C until the expiry date printed on the label. The assay was calibrated using a valid calibrator and measured as sample in duplicates. The verification of the real time stability is on going.

d. Quality Control materials
Users are instructed in the labeling to use quality control samples at least once a day and after each calibration and every time a new bottle of reagent is used. It is recommended to use at least two levels (low and high) of controls. Available controls are Lyphochek® Unassayed Chemistry Control (Human)

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Levels 1 and 2 (Lot number: 27661 and 27662) and were previously cleared under K882486.

e. Detection limit:

Detection limit studies have been carried out in accordance with CLSI EP17-A2 guideline. Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantification (LoQ) studies were performed on two lots of reagents tested on one TC-MATRIX analyzer (K073370). For the LoB and LoD studies, four (4) samples were tested in five (5) replicates over 3 days. For LoQ study, five (5) samples were tested in three (3) replicates over 3 days. The LoD pools consisted of 4 separate pools, and LoQ pools consisted of 5 separate pools near the current bottom of the serum assay ranges. The 9 LoD / LoQ serum pools were prepared by diluting patient serum with artificial serum. The LoB pool consisted of artificial serum base matrix with no carbon dioxide added. LoQ is the lowest concentration that can be detected with ≤ 10%CV. LoB, LoD and LoQ results are summarized in the following table:

Analyte	LoB	LoD	LoQ
CO2 (mmol/L)	0.92	1.5	1.77

f. Analytical specificity:

Interference studies have been carried out in accordance with CLSI EP7-A2 guideline. Two (2) different concentrations of sodium bicarbonate (20 mmol/L and 35 mmol/L) human serum samples were used to evaluate interference testing using one TC-MATRIX analyzer (K073370) and two reagent lots. Pooled human serum samples with added potential interferents were tested in replicates of ten (10) and compared to a sample without interferent. Teco Carbon Dioxide Reagent Set was evaluated for interferences tested by bilirubin (Total and Conjugated), hemoglobin, triglyceride, ascorbic acid, and intralipid in serum samples. The following substances demonstrated no significant bias as defined as ±10% difference from the control results.

| Interferent | concentration at which no significant
interference was observed |
|---------------------|--------------------------------------------------------------------|
| Hemoglobin | 1,000 mg/dL |
| Total Bilirubin | 60 mg/dL |
| Conjugate Bilirubin | 30 mg/dL |
| Triglycerides | 2,000 mg/dL |
| Intralipid | 2,000 mg/dL |
| Ascorbic Acid | 6 mg/dL |

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Image /page/10/Picture/1 description: The image is a logo featuring a green hexagon with the letters "TC" in silver. The letters are stylized with a slight 3D effect, giving them a metallic appearance. The green hexagon provides a solid background, making the letters stand out prominently.

g. Assay cut-off: Not applicable

2. Comparison studies:

a. Method comparison
Serum CO2 correlation determination of the Pointe Scientific Inc. Carbon Dioxide Reagent (X) and Teco Carbon Dioxide Reagent Set (Y) was performed by using 176 patient serum samples ranging from 8.7 to 37.2 mmol/L of CO2 on TC-MATRIX analyzer (K073370), to obtain the following results

y = 0.9785x + 0.2636 mmol/L, R2 = 0.9925 and R=0.9962.

b. Matrix comparison Not applicable.
1. Clinical studies: Not applicable
1. Clinical cut-off: Not applicable
1. Expected values/Reference range:

Reference interval of normal range (Serum): 23 - 33 mmol/L

The provided normal ranges are derived from Tietz NW. Clinical Guide to Laboratory Tests, 3rd ed. Philadelphia, PA: WB Saunders Company; 1995:110-111.

N. Conclusion:

The performance characteristics of the Carbon Dioxide Reagent Set were verified by comparison, precision, linearity, detection limit, specificity and interference, shelf life, and stress studies. Testing results indicate that the Carbon Dioxide Reagent Set performs satisfactorily when used appropriately, as outlined in the package insert. The result of performance studies demonstrates a substantial equivalency on performance between Teco Carbon Dioxide Reagent Set and the predicate device, Pointe Scientific Liquid Stable Reagent.

In summary, the submitted information in this premarket notification is complete and supports a substantial equivalence decision.