(69 days)
Not Found
No
The summary describes a reagent set for a laboratory analyzer and does not mention any AI or ML components. The performance studies focus on standard analytical metrics like precision and accuracy.
No
Justification: The device is described as an "in vitro diagnostic" reagent set for quantitative determination of substances in serum, used for diagnosis and treatment monitoring, not for direct therapy.
Yes
The device is intended for the quantitative determination of substances (BUN, Calcium, Creatinine, Glucose) in serum, and these measurements are explicitly stated to be "used in the diagnosis and treatment of" various diseases and conditions. The text also states, "This reagent set is intended for in vitro diagnostic use only."
No
The device is described as a "Reagent Set" and includes components for chemical analysis (BUN, Calcium, Creatinine, Glucose). This indicates it is a physical product used in laboratory testing, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "This reagent set is intended for in vitro diagnostic use only."
- Nature of the Device: The device is a "Reagent Set" used for the "quantitative determination" of specific analytes (BUN, Calcium, Creatinine, and Glucose) in a biological sample (serum). This is a core function of IVD devices.
- Purpose of Measurements: The intended use describes how the measurements are used in the "diagnosis and treatment" of various diseases and conditions. This directly aligns with the purpose of IVD devices, which are used to provide information for diagnostic purposes.
N/A
Intended Use / Indications for Use
Teco CX3 Reagent Set for SYNCHRON CX System is intended for the quantitative determination of BUN, Calcium, Creatinine and Glucose in serum on Beckman CX3 System.
BUN measurements are used in the diagnosis and treatment of certain renal and metabolic diseases.
Calcium measurements are used in the diagnosis and treatment of parathyroid diseases, a variety of bone diseases, chronic renal and tetany.
Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and a calculation basis for measuring other urine analytes.
Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders, including diabetes mellitus, neonatal hypoglycemia and idiopathic hypoglycemia, and pancreatic islet carcinoma.
This reagent set is intended for in vitro diagnostic use only.
Product codes
Lare, JPP, CGX, CGA, CDQ, CIC
Device Description
The Teco CX3 Reagent Set for SYSNCHRON CX designed for use on the Beckman CX System. The Reagent Set includes BUN, Calcium, Creatinine and Glucose.
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
Method Comparison of Teco CX3 Reagent Set for SYNCHRON CX to Teco BUN Liquid, Teco Calcium Color, Teco Creatinine and Teco Glucose Liquid following the guidelines of NCCLS Guideline EP9-A2 was conducted.
Precision Performance (Human Serum)
- BUN: N=25 for both within-day and day-to-day precision studies for the candidate device.
- Within-Day Sample 1: Mean=18, SD=0.46, CV%=2.5
- Within-Day Sample 2: Mean=49, SD=0.91, CV%=1.9
- Within-Day Sample 3: Mean=97.5, SD=1.3, CV%=1.3
- Day to Day Sample 1: Mean=18, SD=0.37, CV%=2.0
- Day to Day Sample 2: Mean=49, SD=1.04, CV%=2.0
- Day to Day Sample 3: Mean=98, SD=1.14, CV%=1.1
- Acceptability criteria: CV% is within 8%.
- Calcium: N=25 for both within-day and day-to-day precision studies for the candidate device.
- Within-Day Sample 1: Mean=9.1, SD=0.08, CV%=0.9
- Within-Day Sample 2: Mean=12.3, SD=0.11, CV%=0.9
- Within-Day Sample 3: Mean=14, SD=0.16, CV%=0.8
- Day to Day Sample 1: Mean=9.1, SD=0.09, CV%=1.0
- Day to Day Sample 2: Mean=12.4, SD=0.14, CV%=1.1
- Day to Day Sample 3: Mean=14, SD=0.14, CV%=1.0
- Acceptability criteria: CV% is within 5%.
- Creatinine: N=25 for both within-day and day-to-day precision studies for the candidate device.
- Within-Day Sample 1: Mean=1.3, SD=0.04, CV%=2.7
- Within-Day Sample 2: Mean=6.4, SD=0.11, CV%=1.6
- Within-Day Sample 3: Mean=20, SD=0.35, CV%=1.7
- Day to Day Sample 1: Mean=1.3, SD=0.03, CV%=2.2
- Day to Day Sample 2: Mean=6.6, SD=0.24, CV%=3.7
- Day to Day Sample 3: Mean=19.9, SD=0.33, CV%=1.6
- Acceptability criteria: CV% is within 10%.
- Glucose: N=25 for both within-day and day-to-day precision studies for the candidate device.
- Within-Day Sample 1: Mean=78, SD=2.0, CV%=2.5
- Within-Day Sample 2: Mean=255, SD=3.4, CV%=1.3
- Within-Day Sample 3: Mean=735, SD=9.8, CV%=1.5
- Day to Day Sample 1: Mean=79, SD=2.6, CV%=3.3
- Day to Day Sample 2: Mean=262, SD=5.9, CV%=2.2
- Day to Day Sample 3: Mean=734, SD=8.7, CV%=1.2
- Acceptability criteria: CV% is within 10%.
Linearity (Human Serum)
- BUN: 3 to 102 mg/dL.
- Calcium: 1.0 to 15 mg/dL.
- Creatinine: 0.2 to 24 g/dL.
- Glucose: 30 to 750 mg/dL.
Accuracy (Human Serum)
- BUN: R=0.99, Y=1.00 - 0.911. Acceptance Criteria: r > 0.95; Slope: 0.97-1.1.
- Calcium: R=0.96, Y=1.07X +0.60. Acceptance Criteria: r > 0.90; Slope: 0.90-1.1.
- Creatinine: R=0.99, Y=0.97 - 0.11. Acceptance Criteria: r > 0.96; Slope: 0.90-1.1.
- Glucose: R=0.99, Y=0.96X+0.36. Acceptance Criteria: r > 0.90; Slope: 0.85-1.1.
Key Metrics
Precision: CV% reported for within-day and day-to-day for BUN, Calcium, Creatinine, and Glucose.
Accuracy: Correlation coefficient (R) and regression equation (Y) provided for BUN, Calcium, Creatinine, and Glucose.
Linearity: Range of concentrations listed for BUN, Calcium, Creatinine, and Glucose.
Predicate Device(s)
K981106, K864741, K880629, K863926
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1770 Urea nitrogen test system.
(a)
Identification. A urea nitrogen test system is a device intended to measure urea nitrogen (an end-product of nitrogen metabolism) in whole blood, serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.(b)
Classification. Class II.
0
MAR 2 7 2006
K060/20
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1268 N. Lakeview Ave., Anaheim, CA 92807, U.S.A. Phone: (714) 693-7788 Toll Free: 1-800-222-9880 Fax: (714) 693-3838 www.tecodiag.com Email:tecodiag@tecodiag.com
Updated 510K summary Teco CX3 Reagent Set for SYNCHRON CX Contact Name: Jian Vaeches Phone Number: 714-693-7788 ext.131 Prepared Date: 03/20/2006
1
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1268 N. Lakeview Ave., Anaheim, CA 92807, U.S.A. Phone: (714) 693-7788 Toll Free: 1-800-222-9880 Fax: (714) 693-3838 www.tecodiag.com Email:tecodiag@tecodiag.com
Device Name
The device trade names and common/classifications name are:
| Device Trade Name | Common/Classification Name |
|---|---|
| Teco CX3 Reagent Set for SYNCHRON CX System | BUN, CALCIUM, CREATININE, GLUCOSE REGENTS |
Address and Registration
The address and registration number of the manufacturer site for Teco CX3 Reagent Set for SYNCHRON CX System:
TECO Diagnostics 1268 N. Lakeview Ave. Anaheim, CA 92807, U.S.A. FDA Registration # 1832216
Device Classs
ાં બે Teco CX3 Reagent Set has been classified as Class II with Product Code Lare, JPP, CGX, CGA "in vitro" diagnostics reagent set having the classification number: 21 CFR. 862.1770, 21 CFR 862.1145, 21 CFR 862.1225, 21 CFR 862.1345. This is the description available from the classification names listed in the " CDRH Home Page- Listing Database."
Predicate Device Information
The predicate device is Teco BUN Liquid, Teco Calcium Color, Teco Creatinine and Teco Glucose Liquid Reagent.
The 510 (K) approval letter is provided in Appendix I. 510(K) #: K981106, K864741, K880629, K863926. Approval Date: 04-16-1998, 01-09-1987, 03-23-1988, 11-13-1986
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1268 N. Lakeview Ave., Anaheim, CA 92807, U.S.A. Phone: (714) 693-7788 Toll Free: 1-800-222-9880 Fax: (714) 693-3838 www.tecodiag.com Email:tecodiag@tecodiag.com
Labeling and Intended Use
Draft labels and Instructions for use can be found in appendix A.
Intended Use
Teco CX3 Reagent Set for SYNCHRON CX is intended for the quantitative determination of BUN, Calcium, Creatinine and Glucose in serum on Beckman CX3 System.
Device Description and Comparison
The Teco CX3 Reagent Set for SYSNCHRON CX designed for use on the Beckman CX System. The Reagent Set includes BUN, Calcium, Creatinine and Glucose.
Method Comparison of Teco CX3 Reagent Set for SYNCHRON CX to Teco BUN Liquid, Teco Calcium Color, Teco Creatinine and Teco Glucose Liquid following the guidelines of NCCLS Guideline EP9-A2 was conducted.
Comparison with predicate: Similarities Intended use. Sample Handling Subsystem. Operational Environment Performance.
| Predicate Device | Candidate Device | |
|---|---|---|
| Packaging Size | ||
| BUN | 5 x 25 ml & 5 x 5 ml | 500 ml |
| Calcium | 4 x 120 ml | 500 ml |
| Creatinine | 4 x 120 ml | 2000 ml |
| Glucose | 4 x 120 ml | 500 ml |
| Analyzer | General Chemistry Analyzers | SYSCHRON CX3 |
| Components | ||
| BUN | Tris Buffer 100 mmol | |
| 2-Oxoglutarate 5 mmol | ||
| Urease >20,000 U/L | ||
| GLDH > 1500 U/L | ||
| NADH 0.25 mmol/L | Urease >592 U/mL |
Differences
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1268 N. Lakeview Ave., Anaheim, CA 92807, U.S.A. Phone: (714) 693-7788 Toll Free: 1-800-222-9880 Fax: (714) 693-3838 www.tecodiag.com Email:tecodiag@tecodiag.com
| Calcium | O-Cresolphthalein Complexone 0.14 mM | Arsenazo III 0.15 mml/L |
|---|---|---|
| 8-Hydroxyquinoline 13 mM | ||
| Diethylamide 363 mM | ||
| Creatinine | Picric Acid 10mM | Picric Acid 50mM |
| Sodium Hydroxide 240mM | Sodium Hydroxide 0.188 mM | |
| Glucose | Glucose Oxidase 15 u/ml | Glucose Oxidase 590 u/ml |
| Peroxidase 1.2 u/ml | Ethanol 10% | |
| 4-Aminoantipyrine 0.38 mM | Potassium Iodide 0.04 mM | |
| p-Hydroxybenzene Sulfonate 10 mM |
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1268 N. Lakeview Ave., Anaheim, CA 92807, U.S.A. Phone: (714) 693-7788 Toll Free: 1-800-222-9880 Fax: (714) 693-3838 www.tecodiag.com Email:tecodiag@tecodiag.com
Standard/ Guidance Document Referenced (if applicable)
NCCLS EP5-A-Evaluation of Precision Performance of Clinical Chemistry Devices NCCLS EP6-A --- Evaluation of Linearity of Quantitative Analytical Methods NCCLS EP9-A---Method Comparison and Bias Estimation Using Patient Samples
Test Principle
BUN (Urea Nitrogen) is hydrolyzed by urease to produce ammonium and bicarbonate which resulted in the increase of solution conductivity which is directly proportional to the concentration of BUN present in the test.
Calcium reacts with Arsenazo to form an bluish-purple chromophore which is measured spectrophotometrically at 650 nm. A reagent blank reading is taken just prior to sample injection, and a final absorbance reading is taken 21 seconds later. The differential absorbance, corrected for the reagent blank, is directly proportional to the calcium concentration.
Creatinine from the sample combines with the reagent to produce a red color complex. Absorbance reading is taken at both 520nm and 560nm at 25.6 seconds after picking up sample. The differential absorbance has been shown to be a direct measure of the concentration of creatinine in the sample.
SYSNCHRON CX3 determines glucose concentration by an oxygen rate method using a glucose Oxygen electrode. The rate of oxygen depletion is proportional to the glucose concentration in the samples.
5
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1268 N. Lakeview Ave., Anaheim, CA 92807, U.S.A. Phone: (714) 693-7788 Toll Free: 1-800-222-9880 Fax: (714) 693-3838 www.tecodiag.com Email:tecodiag@tecodiag.com
TECO DIAGNOSTICS
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1268 N. Lakeview Ave., Anaheim, CA 92807, U.S.A. Phone: (714) 693-7788 Toll Free: 1-800-222-9880 Fax: (714) 693-3838 www.tecodiag.com Email:tecodiag@tecodiag.com
Substantial Equivalence
The Teco CX3 Reagent Set for SYNCHRON CX System is substantially equivalent to other devices legally marketed in the United States. We have compared TECO Diagnostics Teco CX3 Reagent Set for SYNCHRON CX System to TECO Diagnostics Teco BUN Liquid, Teco Calcium Color, Teco Creatinine and Teco Glucose Liquid Reagent for Hitachi.The 510 (K) numbers are K981106, K864741, K880629, and K863926. Both devices are for the quantitative determination of the same analyst in serum.
Summary of Design Control Activities
The risk analysis method used to assess the impact of modifications was a Failure Modes and Effects Analysis (FMEA). The design verification tests that were performed as a result of this risk analysis assessment are listed in table 1&2 below. The tests data can also be found in appendix C through F.
1. Table 1 -- Performance Characteristics (Human Serum)
| Feature | Predicate Device | Candidate Device | |||
|---|---|---|---|---|---|
| Sample 1 | Sample 2 | Sample 1 | Sample 2 | Sample 3 | |
| Precision | |||||
| Within-Day | N=20 | N=20 | N=25 | N=25 | N=25 |
| Mean=12.9 | Mean=51.8 | Mean=18 | Mean=49 | Mean=97.5 | |
| SD=0.33 | SD=0.74 | SD=0.46 | SD=0.91 | SD=1.3 | |
| CV%=2.62 | CV%=1.43 | CV%=2.5 | CV%=1.9 | CV%=1.3 | |
| Day to Day | Sample 1 | Sample 2 | Sample 1 | Sample 2 | Sample 3 |
| N=20 | N=20 | N=25 | N=25 | N=25 | |
| Mean=12.4 | Mean=44.6 | Mean=18 | Mean=49 | Mean=98 | |
| SD=0.15 | SD=0.75 | SD=0.37 | SD=1.04 | SD=1.14 | |
| CV%=1.2 | CV%=1.67 | CV%=2.0 | CV%=2.0 | CV%=1.1 |
Teco CX3 Reagent Set, the acceptability of CV% in BUN test is within 8%
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1268 N. Lakeview Ave., Anaheim, CA 92807, U.S.A. Phone: (714) 693-7788 Toll Free: 1-800-222-9880 Fax: (714) 693-3838 www.tecodiag.com Email:tecodiag@tecodiag.com
Calcium:
| Feature | Predicate Device | Candidate Device | ||||
|---|---|---|---|---|---|---|
| Precision | ||||||
| Within-Day | Sample 1 | |||||
| N=20 | ||||||
| Mean=9.1 | ||||||
| SD=0.39 | ||||||
| $CV%=4.3$ | Sample 2 | |||||
| N=20 | ||||||
| Mean=13.7 | ||||||
| SD=0.02 | ||||||
| $CV%=0.2$ | Sample 1 | |||||
| N=25 | ||||||
| Mean=9.1 | ||||||
| SD=0.08 | ||||||
| $CV%=0.9$ | Sample 2 | |||||
| N=25 | ||||||
| Mean=12.3 | ||||||
| SD=0.11 | ||||||
| $CV%=0.9$ | Sample 3 | |||||
| N=25 | ||||||
| Mean=14 | ||||||
| SD=0.16 | ||||||
| $CV%=0.8$ | ||||||
| Day to Day | Sample 1 | |||||
| N=20 | ||||||
| Mean=9.2 | ||||||
| SD=0.21 | ||||||
| $CV%=2.2$ | Sample 2 | |||||
| N=20 | ||||||
| Mean=13.3 | ||||||
| SD=0.32 | ||||||
| $CV%=2.4$ | Sample 1 | |||||
| N=25 | ||||||
| Mean=9.1 | ||||||
| SD=0.09 | ||||||
| $CV%=1.0$ | Sample 2 | |||||
| N=25 | ||||||
| Mean=12.4 | ||||||
| SD=0.14 | ||||||
| $CV%=1.1$ | Sample 3 | |||||
| N=25 | ||||||
| Mean=14 | ||||||
| SD=0.14 | ||||||
| $CV%=1.0$ |
Teco CX3 Reagent Set, the acceptability of CV% in Calcium test is within 5%
Creatinine:
| Feature | Predicate Device | Candidate Device | |||
|---|---|---|---|---|---|
| Precision | |||||
| Within-Day | Sample 1 | ||||
| N=20 | |||||
| Mean=1.9 | |||||
| SD=0.05 | |||||
| CV%=2.6 | Sample 2 | ||||
| N=20 | |||||
| Mean=8.2 | |||||
| SD=0.6 | |||||
| CV%=7.3 | Sample 1 | ||||
| N=25 | |||||
| Mean=1.3 | |||||
| SD=0.04 | |||||
| CV%=2.7 | Sample 2 | ||||
| N=25 | |||||
| Mean=6.4 | |||||
| SD=0.11 | |||||
| CV%=1.6 | Sample 3 | ||||
| N=25 | |||||
| Mean=20 | |||||
| SD=0.35 | |||||
| CV%=1.7 | |||||
| Day to Day | Sample 1 | ||||
| N=20 | |||||
| Mean=2.0 | |||||
| SD=0.2 | |||||
| CV%=10 | Sample 2 | ||||
| N=20 | |||||
| Mean=8.2 | |||||
| SD=0.4 | |||||
| CV%=4.6 | Sample 1 | ||||
| N=25 | |||||
| Mean=1.3 | |||||
| SD=0.03 | |||||
| CV%=2.2 | Sample 2 | ||||
| N=25 | |||||
| Mean=6.6 | |||||
| SD=0.24 | |||||
| CV%=3.7 | Sample 3 | ||||
| N=25 | |||||
| Mean=19.9 | |||||
| SD=0.33 | |||||
| CV%=1.6 |
Teco CX3 Reagent Set, the acceptability of CV% in Creatinine test is within 10%
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1268 N. Lakeview Ave., Anaheim, CA 92807, U.S.A. Phone: (714) 693-7788 Toll Free: 1-800-222-9880 Fax: (714) 693-3838 www.tecodiag.com_Email:tecodiag@tecodiag.com
Glucose:
| Feature | Predicate Device | Candidate Device | |||
|---|---|---|---|---|---|
| Sample 1 | Sample 2 | Sample 1 | Sample 2 | Sample 3 | |
| Precision | |||||
| Within-Day | N=20 | ||||
| Mean=87 | |||||
| SD=4.2 | |||||
| CV%=4.8 | N=20 | ||||
| Mean=282 | |||||
| SD=5.4 | |||||
| CV%=1.9 | N=25 | ||||
| Mean=78 | |||||
| SD=2.0 | |||||
| CV%=2.5 | N=25 | ||||
| Mean=255 | |||||
| SD=3.4 | |||||
| CV%=1.3 | N=25 | ||||
| Mean=735 | |||||
| SD=9.8 | |||||
| CV%=1.5 | |||||
| Day to Day | Sample 1 | ||||
| N=20 | |||||
| Mean=85 | |||||
| SD=3.7 | |||||
| CV%=4.3 | Sample 2 | ||||
| N=20 | |||||
| Mean=287 | |||||
| SD=9.6 | |||||
| CV%=3.3 | Sample 1 | ||||
| N=25 | |||||
| Mean=79 | |||||
| SD=2.6 | |||||
| CV%=3.3 | Sample 2 | ||||
| N=25 | |||||
| Mean=262 | |||||
| SD=5.9 | |||||
| CV%=2.2 | Sample 3 | ||||
| N=25 | |||||
| Mean=734 | |||||
| SD=8.7 | |||||
| CV%=1.2 |
Teco CX3 Reagent Set, the acceptability of CV% in Clucose test is within 10%
Table 2-Performance Characteristics (Human Serum) BUN:
| Feature | Candidate Device | Predicate Device |
|---|---|---|
| Linearity | 3 to 102 mg/dL | up to 80 mg/dL |
| Accuracy | R=0.99 | |
| Y= $1.00-0.911$ | R=0.99 | |
| Y= $0.962 X - 0.721$ | ||
| Expect values/ | ||
| Reference range | 15-39 mg/dL | 8-23 mg/L |
Teco CX3 Reagent Set BUN test, Acceptance Criteria of Accuracy: r > 0.95; Slope: 0.97-1.1
Calcium:
| Feature | Candidate Device | Predicate Device |
|---|---|---|
| Linearity | 1.0 to 15 mg/dL | up to 20 mg/dL |
| Accuracy | R=0.96 | |
| Y=1.07X +0.60 | R=0.97 | |
| Y=0.94 X+ 0.53 | ||
| Expect values/ | ||
| Reference range | 8.4-10.2 mg/dL | 8.5-10.5 mg/dL |
Teco CX3 Reagent Set Calcium test, Acceptance Criteria of Accuracy: r > 0.90; Slope: 0.90-1.1
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1268 N. Lakeview Ave., Anaheim, CA 92807, U.S.A. Phone: (714) 693-7788 Toll Free: 1-800-222-9880 Fax: (714) 693-3838 www.tecodiag.com Email:tecodiag@tecodiag.com
Creatinine:
| Feature | Candidate Device | Predicate Device |
|---|---|---|
| Linearity | 0.2 to24g/dL | Up to 25 mg/dL |
| Accuracy | $R=0.99$ | |
| $Y=0.97 -0.11$ | $R=0.99$ | |
| $Y=0.96 X+ 0.06$ | ||
| Expect values/ | ||
| Reference range | 0.6-1.3 mg/dL | Male: 0.9-1.5 mg/dL |
| Female: 0.7-1.37 mg/dL |
Teco CX3 Reagent Set Creatinine test, Acceptance Criteria of Accuracy: r > 0.96; Slope: 0.90-1.1
Glucose:
| Feature | Candidate Device | Predicate Device |
|---|---|---|
| Linearity | 30 to 750 mg/dL | up to 500 mg/dL |
| Accuracy | R=0.99 | |
| Y=0.96X+0.36 | R=0.99 | |
| Y=1.02 X+3.1 | ||
| Expect values/ | ||
| Reference range | 70-105 mg/dL | 70-106 mg/dL |
Teco CX3 Reagent Set Glucose test, Acceptance Criteria of Accuracy: r > 0.90; Slope: 0.85-1.1
9
DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 2 7 2006
Ms. Jian Vaeches Teco Diagnostics 1268 N. Lakeview Ave Anaheim, CA 92807
Re:
K060120 Trade/Device Name: Teco CX3 Reagent Set for SYNCHRON CX System Regulation Number: 21 CFR§ 862.1770 Regulation Name: Urea nitrogen test system Regulatory Class: Class II Product Code: CDQ, CIC, CGX, CGA Dated: March 16, 2006 Received: March 16, 2006
Dear Ms. Vaeches:
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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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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 (240) 276-0484. 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/industry/support/index.html.
Sincerely vours.
Alberto Gutierrez
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K060120
Device Name: Teco CX3 Reagent Set for SYNCHRON CX System
Indications For Use: Teco CX3 Reagent Set for SYNCHRON CX System is intended for the quantitative determination of BUN, Calcium, Creatinine and Glucose in serum on Beckman CX3 System.
BUN measurements are used in the diagnosis and treatment of certain renal and metabolic diseases.
Calcium measurements are used in the diagnosis and treatment of parathyroid diseases, a variety of bone diseases, chronic renal and tetany.
Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and a calculation basis for measuring other urine analytes.
Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders, including diabetes mellitus, neonatal hypoglycemia and idiopathic hypoglycemia, and pancreatic islet carcinoma.
This reagent set is intended for in vitro diagnostic use only.
Prescription Use J
AND/OR
Over-The-Counter Use
(Part 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
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Of In Vitro Diagnostic Device Evaluation and Safe
n Sign-Off
060120