The SenDx 100™ pH, Blood Gas and Electrolyte Analysis System (SenDx 100™) is intended to measure blood oxygen, carbon dioxide, pH, sodium, potassium, chloride, ionized calcium and hematocrit in whole blood.

The SenDx 100™ system can be used in the laboratory, near patient, or in point-of-care settings. It is intended for the measurement of blood gases, electrolytes and hematocrit in arterial or venous whole blood samples.

Device Description

The SenDx 100™ system consists of the analyzer, a multi-use, disposable sensor cassette and a calibration solution pack. A bar code label containing lot and sensor-specific identifying parameters accompanies each new sensor cassette and calibration solution pack.

The SenDx 100™ line is available in two versions:
Model SD 100 B with modem
Model SD 100 IB without modem for international use

The SD100B is sold in the United States and is UL certified. The unit is battery powered and requires an external battery charger that is provided by SenDx Medical, Inc. Use only Jerome Industries power supply model WSZ118M which requires 100 to 250 VAC, 50 to 60 Hertz with these units. It also has a modem.

The SD1001B is sold internationally and is certified by TUV Rheinland. This unit is also battery powered and requires an external battery charger that is provided by SenDx Medical, Inc. Use only Advance Power Solutions power supply model AD-740U-1180 which requires 100 to 240 VAC, 50 to 60 Hertz with these units. This model is not equipped with a modem.

The SenDx 100™ analyzer utilizes microprocessor controlled electronics. The microprocessor controls the touch screen display, the analog electronics for processing sensor output, and the integral thermal printer. The printer provides a hard copy of the measured and calculated values. Samples are introduced into the analyzer via an aspiration stylus.

The SenDx 100™ sensor incorporates microelectrode technology for the measurement of blood oxygen (pO2), carbon dioxide (pCO2), pHx, sodium (Na+), potassium (K+), chloride (Cl-), ionized calcium (iCa++), and hematocrit (Hct) in a multi-use, disposable cassette assembly.

The sensors are analogous to traditional electrode methodologies for the measurement of blood gases and electrolytes. A Clark cell for pO2 measurement and potentiometric ion-selective electrodes for the measurement of pH, pCO2, Na+, K+, Cl- and iCa++ have been miniaturized for placement on a 1-3/8" x 3/8" sensing "chip". Hematocrit is measured by using conductivity.

The sensors are contained in a low volume flow-through cell. The sensor cassette contains reference electrodes for the potentiometric sensors and an integral temperature sensor and heating element for precise temperature control. Calibration and analysis are carried out at 37.0°C. The SenDx 100™ analyzer allows for patient temperature correction over the range of 12-45°C.

All SenDx 100™ sensor cassettes are 100% tested at the factory with multiple precision reference solutions.

Calibration of the system is accomplished using a calibration solution pack which contains two levels of precision tonometered electrolyte solutions packaged in gas tight disposable cartridges. Precise pH, blood gas, and electrolyte calibration values for each pack are provided on an attached calibration bar code label.

The SenDx 100TM performs two point calibrations at automatic intervals. Throughout the calibration and sample analysis phases, sensor signals are continuously monitored. If any abnormal conditions are detected, an error message is generated.

Blood analysis and the subsequent system calibration and flush take approximately 50-75 seconds. After analysis, pH, pCO2, pO2, Na+, K+, Cl-, iCa++, and Hct measurement results are displayed on the analyzer touch screen. The measured values and derived values (HCO3-, BEb, BEecf, TCO3, SBC, Hb, and %O2 Sat) are automatically printed.

The SenDx 100™ system can be interfaced via the RS232 serial data port with PC based or LIS/HIS data management systems.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information regarding the SenDx 100 Blood Gas and Electrolyte Analysis System, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a numerical or categorical format with pass/fail thresholds. Instead, it demonstrates the device's performance through correlation and precision studies against predicate devices and known control values. The implicit acceptance criterion is that the device demonstrates performance substantially equivalent to these predicate devices or acceptable precision for clinical use.

Here's a summary of the reported performance, categorized by study type:

A. Linearity of Recovery (Internal Study)
(Comparison against Corning 850 for pH, pCO2, pO2, Na+, K+, Cl-, iCa++; spun hematocrit for Hct)

Analyte	n	Slope	r	Intercept	Std Error Sy.x
pH	333	1.21	0.99	-1.56	0.017
pCO2	384	1.00	0.99	0.92	1.83
pO2	321	1.01	1.00	0.51	3.0
Na+	465	1.09	0.99	-11.17	2.15
K+	475	1.06	1.00	-0.18	0.13
Cl-	414	1.03	0.99	1.10	1.66
iCa++	600	1.01	1.00	-0.04	0.04
Hct	747	1.12	0.98	-2.42	1.69

B. Correlations (Internal Study)
(Comparison against Corning 850 and spun hematocrit using tonometered and spiked whole blood)

Analyte	n	Slope	r	Intercept	Std Error Sy.x
pH	472	1.23	0.99	-1.65	0.013
pCO₂	413	1.00	0.99	0.49	1.62
pO₂	1677	0.97	0.99	3.81	5.56
Na⁺	619	1.17	0.99	-24.22	2.11
K⁺	601	1.02	1.00	0.07	0.14
Cl⁻	619	1.01	0.99	-0.10	1.54
iCa⁺⁺	621	1.33	0.99	-0.4	0.05
Hct	1229	1.12	0.95	-4.63	2.07

C. Precision (Internal Study) - Using RNA Medical Qualidata and Hct Levels
(Summary of Mean, S.D., %CV)

Analyte	Mean	S. D.	%CV
pH
Level 1	7.177	0.006	0.089
Level 2	7.416	0.003	0.047
Level 3	7.612	0.006	0.073
pCO₂
Level 1	67.5	2.1	3.1
Level 2	45.0	0.7	1.7
Level 3	24.7	0.7	2.8
pO₂
Level 1	71.4	3.0	4.3
Level 2	109.5	2.0	1.9
Level 3	146.0	1.5	1.0
Na⁺
Level 1	107.6	0.7	0.6
Level 2	130.1	0.5	0.4
Level 3	157.4	0.6	0.4
K⁺
Level 1	1.85	0.02	1.30
Level 2	4.39	0.03	0.78
Level 3	6.46	0.06	0.92
iCa⁺⁺
Level 1	1.55	0.02	1.32
Level 2	1.19	0.01	0.97
Level 3	0.54	0.01	2.03
Hct
Low	35.0	0.3	0.7
High	58.2	0.5	0.8
Cl⁻
Level 1	74.0	1.1	1.5
Level 2	94.0	0.5	0.6
Level 3	127.0	1.0	0.8

D. Clinical Study - Hospital Stat Lab (Representative Site)
(Comparison against Corning 865, Nova Stat Profile 5, Corning Co-oximeter, and spun hematocrit)

Analyte	n	Slope	r	Intercept	Std Error Sy.x
pH	120	0.89	0.99	0.841	0.013
pCO2	114	0.84	0.99	5.93	1.03
pO2	119	1.02	1.00	-0.08	5.77
Na+	120	0.98	0.89	3.04	2.48
K+	120	1.01	0.99	-0.15	0.07
iCa++	118	0.85	0.94	0.17	0.03
Hct	102	1.11	0.93	-4.03	2.55

E. Clinical Study - Hospital Operating Room Point-Of-Care (Representative Site)
(Comparison against Mallinckrodt Hem-Premier)

Analyte	n	Slope	r	Intercept	Std Error Sy.x
pH	112	0.78	0.99	1.66	0.01
pCO2	106	0.80	0.96	4.96	1.56
pO2	108	0.79	0.95	54	28.5
Na+	112	0.85	0.90	17.1	1.98
K+	112	1.06	0.98	-0.4	0.20
iCa++	97	0.88	0.95	0.12	0.06
Hct	111	1.03	0.99	-2.35	1.85

F. Clinical Precision Study (Site to Site)
(Summarized data from four clinical sites for pH, blood gases, electrolytes and hematocrit)

pH: Site to Site* Mean ranges from 7.192 to 7.602, S.D. 0.006-0.008, %CV 0.075-0.102.
pCO2: Site to Site* Mean ranges from 23.3 to 66.4, S.D. 0.385-1.883, %CV 1.653-2.835.
pO2: Site to Site* Mean ranges from 68.2 to 143.1, S.D. 1.328-2.546, %CV 1.236-3.667.
Na+: Site to Site* Mean ranges from 107.4 to 156.2, S.D. 1.176-2.133, %CV 0.753-1.987.
K+: Site to Site* Mean ranges from 1.81 to 6.43, S.D. 0.019-0.047, %CV 0.728-1.055.
iCa++: Site to Site* Mean ranges from 0.49 to 1.52, S.D. 0.008-0.045, %CV 1.681-2.959.
Hct: Site to Site* Mean ranges from 34.2 to 57.3, S.D. 0.546-0.797, %CV 1.391-1.594.

The conclusion states that the performance is "substantially equivalent" to predicate devices, implying these reported values meet the unstated acceptance criteria for equivalency.

2. Sample Size Used for the Test Set and Data Provenance

Non-Clinical Testing (Linearity and Correlations):
- Sample Sizes: For linearity, individual analyte 'n' values range from 321 (pO2) to 747 (Hct). For correlations, 'n' values range from 413 (pCO2) to 1677 (pO2). These represent the number of samples tested for each analyte.
- Data Provenance: The data was generated on-site at SenDx Medical, Inc. The samples used were "pooled whole blood" for linearity of pH, K+, Na+, Cl-, iCa++, and "tonometered and spiked whole blood" for correlations. This indicates the data is retrospective in nature, likely laboratory-controlled samples, not from real patients.
Clinical Testing:
- Sample Sizes: Over 400 split-samples were evaluated across four clinical sites. Individual analyte 'n' values for representative sites range from 97 (iCa++ in OR POC) to 120 (pH, Na+, K+ in Stat Lab). This indicates the number of patient samples.
- Data Provenance: Conducted at four different geographical sites (hospitals: Stat Lab and Operating Room Point-Of-Care). These were prospective clinical studies using patient samples ("split-samples"). The country of origin is not explicitly stated but implied to be the US given the submission to the FDA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not mention the use of "experts" to establish ground truth in the typical sense of human readers for images or diagnoses. Instead, the ground truth was established by measurements from established, legally marketed predicate devices (e.g., Corning 850, Corning 865, Nova Stat Profile 5, Mallinckrodt Gem-Premier, and spun hematocrit).

The qualifications of operators for these predicate devices or for collecting calibration data are not specified, but it's implied they are trained laboratory personnel ("trained technologists, nurses, physicians, and therapists" as per the SenDx 100's intended use).

4. Adjudication Method for the Test Set

Not applicable. The ground truth was established by instrumental measurements from predicate devices, not by human interpretation requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This type of study is designed to assess the impact of an AI algorithm on human reader performance, typically for diagnostic imaging interpretation. This device is a blood gas and electrolyte analyzer, and its output is a direct quantitative measurement, not an interpretation by a human reader.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

Yes, this entire submission is essentially a standalone performance study. The SenDx 100 system itself is the "algorithm" (or rather, the automated analytical device) that measures the parameters. Its performance is compared directly against established laboratory reference methods and other commercially available automated analyzers without human intervention in the measurement process itself, beyond sample introduction and standard operating procedures. The data presented are the results from the SenDx 100 as an automated system.

7. Type of Ground Truth Used

The ground truth for both non-clinical and clinical testing was established by:

Measurements from Predicate Devices: For all analytes, readouts from the Corning 850, Corning 865, Nova Stat Profile 5, and Mallinckrodt Gem-Premier served as the comparison for blood gases and electrolytes.
Spun Hematocrit (Micro-centrifuge): For hematocrit measurements.
Reference Materials: RNA Medical Qualidata levels 1, 2, 3 for blood gases and electrolytes, and RNA Medical hematocrit levels low and high were used in precision studies.
Tonometered and Spiked Whole Blood: Used in non-clinical studies to create known concentrations for linearity and correlation.

This is best described as comparison against established reference methods and certified reference materials.

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of an AI/machine learning algorithm. The SenDx 100 is an electrochemical and optical measurement device, not an AI algorithm that learns from data in that sense.

However, the "training" analogous to an AI algorithm would be the internal development and calibration processes. The document states:

"All SenDx 100™ sensor cassettes are 100% tested at the factory with multiple precision reference solutions."
The system performs "two point calibrations at automatic intervals" using "calibration solution pack which contains two levels of precision tonometered electrolyte solutions."

The specific sample size (number of runs, types of solutions) for these internal factory tests and ongoing calibrations is not provided, only that they are performed extensively ("100% tested," "multiple precision reference solutions").

9. How the Ground Truth for the Training Set Was Established

As explained above, there isn't a "training set" in the common AI sense. For the internal development and calibration of the instrument, the ground truth was established by:

Known concentrations of precision reference solutions: Used for factory testing and calibration.
Precision tonometered electrolyte solutions: Used in calibration packs for ongoing automatic calibrations.

These solutions would have their analyte values determined by highly accurate, often gravimetric or spectroscopically verified, methods.

Summary

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15973742

SenDx Medical, Inc. 1945 Palomar Oaks Way Carlsbad, California 92009 Phone: 760.930.6300 Fax: 760.930.6320

DEC - 3 1997

SenDx Medical, Inc. Company Name:

1945 Palomar Oaks Way Address: Carlsbad, California 92009

Phone: 760.930.6300

760.930.6320 Fax:

Contact Person: Ruben Chairez

Date: September 15, 1997

510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.

The assigned 510 (k) number is: ___________________

ు గ్రామం
నుండి

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A. Device Proprietary name:	SenDx 100 Blood Gas and Electrolyte Analysis System
B. Device common name:	Blood Gas and Electrolyte Analyzer
C. Device classification name:
• 21 CFR 862.1120:	Blood gases (CO2, pO2) and blood pH test system Class II
• 21 CFR 862.1665	Sodium test system Class II
• 21 CFR 862.1600	Potassium test system Class II
• 21 CFR 862.1145	Calcium test system Class II
• 21 CFR 862.1170	Electrode, Ion-Specific, Chloride Class II
• 21 CFR 864.6400	Hematocrit measuring device Class II

ﺳﺴﺴﺴ

ਸੂਨੀ ਦੇ ਸੰਗ੍ਰਹਿ ਹੈ।

ਹਵਾਲੇ

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Statement of Substantial Equivalence

ﻟﺴﻴﺮ- ﺗﺮ

The SenDx 100 pH, Blood Gas and Electrolyte Analysis System is substantially equivalent to other blood gas, electrolyte and hematocrit measuring systems used with whole blood.

This 510(k) submission seeks clearance for modifications to the SenDx 100 line as embodied in the two models SD 100B and SD 100IB. These modifications include:

1. Addition of chloride to the electrolyte panel.
1. Modification to the Performance Characteristics section of the Operators Manual.

The SenDx 100 (Model SD100B and SD100IB) is substantially equivalent to other blood gas analyzers such as:

StatPal versions were previously submitted and cleared for marketing under 510(k) document Control numbers:

K903965/B K914560 K922631/B.

These three StatPal versions were found by FDA to be substantially equivalent to the Mallinckrodt® GEM@-STAT, among other instruments.

The SenDx 100 system was originally submitted and cleared for marketing under Document Control number K954482. This SenDx 100 system was also found by FDA to be substantially equivalent to the Mallinckrodt® GEM®-PREMIER among other instruments.

The SenDx 100 is substantially equivalent to other blood gas and electrolyte systems such as:

1. The Ciba-Corning, Corning 865 Blood Gas and Electrolyte System 510(k) Document Control number K 934907.
1. The Mallinckrodt® GEM®-PREMIER Blood Gas and Electrolyte Monitor, 510(k) Document Control number K 910305.
1. The NOVA Biomedical, NOVA STAT Profile 5, 510(k) Document Control Number K874832.

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Description

The SenDx 100™ line is available in two versions:

Model SD 100 B with modem Model SD 100 IB without modem for international use

The SenDx 100™ sensor incorporates microelectrode technology for the measurement of blood oxygen (p(), carbon dioxide (pCO2), pHx, sodium (Na*), potassium (K*), chloride (Cl1), ionized calcium (iCat'), and hematocrit (Hct) in a multi-use, disposable cassette assembly.

The sensors are analogous to traditional electrode methodologies for the measurement of blood gases and electrolytes. A Clark cell for DO, measurement and potentiometric ion-selective electrodes for the measurement of pH, pCO,, Na , K , Cl and iCa * have been miniaturized for placement on a 1-3/8" x 3/8" sensing "chip". Hematocrit is measured by using conductivity.

All SenDx 100™ sensor cassettes are 100% tested at the factory with multiple precision reference solutions.

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Blood analysis and the subsequent system calibration and flush take approximately 50-75 seconds. After analysis, pH, pCO2, pO2, Na', K+, Cl; iCa*, and Hct measurement results are displayed on the analyzer touch screen. The measured values and derived values (HCO), BEb, BEecf, TCO3, SBC, Hb, and %02 Sat) are automatically printed.

The SenDx 100™ system can be interfaced via the RS232 serial data port with PC based or LIS/HIS data management systems.

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Intended Use

্রামের

The SenDx 100™ pH, Blood Gas and Electrolyte Analysis System (SenDx 100™) is a portable, automated analyzer that measures blood oxygen, carbon dioxide, pH, sodium, potassium, chloride, ionized calcium, and hematocrit in whole blood. The SenDx 100™ system is intended for use by trained technologists, nurses, physicians, and therapists. It can be used in laboratory, near patient or point-of-care settings.

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510(k) Number (if known):

Device Name: SenDx 100™ pH, Blood Gas and Electrolyte Analysis System

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUED ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

্রামের

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

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Technological Characteristics

As described in a previous 510(k) (K922631/B) for StatPal II, the StatPal II and the Mallinckrodt® GEM® STAT are primarily intended for determination of arterial pH, pO2 and pCO2. Similarly, as described in the previous 510(k) (K954482) for the SenDx 100™ , this device intended to be used for determination of arterial or venous pH, pCO2, pO2, Na', K', ionized Ca* and hematocrit in whole blood. The present 510(k) submission adds chloride to the electrolyte panel of the SenDx 100™. The SenDx 100 is similar to the Mallinckrodte GEM®-PREMIER, Corning 850 & 865, and NOVA STAT Profile 5 in intended use, methods of application and principles of operation.

The methods of application involve trained medical personnel in a central lab, stat lab or critical care environment. The StatPal II, SenDx 100 and GEM®-PREMIER can also be used near the patient due to the portable nature of the devices. In each of these devices, the principles of operation are similar or the same:

• polarographic(amperometric)	pO₂ measurement
• potentiometricmeasurement	pH, Na+, K+, Cl-, iCa++, and pCO₂ measurement
• conductance	Hematocrit measurement

The SenDx 100 poses the same type of questions about safety and effectiveness of the equivalent devices.

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NON-CLINICAL TESTING

Performance data was generated on-site at SenDx Medical, Inc. Comparisons were done with the following reference instruments:

Corning 850 and spun hematocrit (micro centrifuge) o

Linearity of Recovery:

SenDx Medical, Inc. a
Linearity of recovery for pCO, and pO, was assessed versus target recovery values employing blood tonometry. Linearity of recovery for pH, K', Na , Cl and iCa* was assessed by selecting from the pooled whole blood data from five ranges evenly spread throughout the total range of measurement. Each range consisted of approximately 50 - 100 blood samples. The values for these ranges were independently verified against a Corning 850 Blood Gas and Electrolyte Analyzer. The resulting data were analyzed using full linear regression analysis. Regression slope, intercept, and correlation coefficient are reported.

Analyte	n	Slope	r	Intercept	Std ErrorSy.x
pH	333	1.21	0.99	-1.56	0.017
pCO2	384	1.00	0.99	0.92	1.83
pO2	321	1.01	1.00	0.51	3.0
Na+	465	1.09	0.99	-11.17	2.15
K+	475	1.06	1.00	-0.18	0.13
Cl-	414	1.03	0.99	1.10	1.66
iCa++	600	1.01	1.00	-0.04	0.04
Hct	747	1.12	0.98	-2.42	1.69

Correlations:

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SenDx Medical, Inc. .
The study was performed at SenDx Medical, Inc. comparing the SenDx 100™ to a Corning 850 Blood Gas and Electrolyte Analyzer and a spun hematocrit (micro-centerfuge). Tonometered and spiked whole blood were tested in order to verify the accuracy of the SenDx 100™ system.

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Analyte	n	Slope	r	Intercept	Std ErrorSy.x
pH	472	1.23	0.99	-1.65	0.013
pCO₂	413	1.00	0.99	0.49	1.62
pO₂	1677	0.97	0.99	3.81	5.56
Na⁺	619	1.17	0.99	-24.22	2.11
K⁺	601	1.02	1.00	0.07	0.14
Cl⁻	619	1.01	0.99	-0.10	1.54
iCa⁺⁺	621	1.33	0.99	-0.4	0.05
Hct	1229	1.12	0.95	-4.63	2.07

Precision

SenDx Medical, Inc. g
An in-house precision study using quality control materials was performed over a period of 15 days. This study utilized multiple lots of sensor cassettes and calibration packs.

RNA Medical Qualidata levels 1, 2, 3 were used for blood gases and electrolytes, and RNA Medical hematocrit levels low and high were used for hematocrit. Each level was run in duplicate twice a day.

SenDx 100™		Mean	S. D.	%CV		Mean	S. D.	%CV
	pH				$pCO_2$(mmHg)
Level 1		7.177	0.006	0.089		67.5	2.1	3.1
Level 2		7.416	0.003	0.047		45.0	0.7	1.7
Level 3		7.612	0.006	0.073		24.7	0.7	2.8
	$pO_2$(mmHg)				$Na^+$(mmol/L)
Level 1		71.4	3.0	4.3		107.6	0.7	0.6
Level 2		109.5	2.0	1.9		130.1	0.5	0.4
Level 3		146.0	1.5	1.0		157.4	0.6	0.4
	$K^+$(mmol/L)				$iCa^{++}$(mmol/L)
Level 1		1.85	0.02	1.30		1.55	0.02	1.32
Level 2		4.39	0.03	0.78		1.19	0.01	0.97
Level 3		6.46	0.06	0.92		0.54	0.01	2.03
	Hct(%)				Cl(mmol/L)
Low		35.0	0.3	0.7
High		58.2	0.5	0.8	Level 1	74.0	1.1	1.5
					Level 2	94.0	0.5	0.6
					Level 3	127.0	1.0	0.8

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CLINICAL TESTING

Clinical studies were conducted of the SenDx 100™ system at four different geographical sites. This study involved four different SenDx 100™ analyzers, and multiple lots of sensor cassettes and calibrant solution packs. These clinical studies included split sample testing of over 50 samples per site and precision testing with QC control samples.

Hospital Stat Lab �

Clinical studies comparing the SenDx 100 system to the Corning 865, Nova Stat Profile 5, Corning Co-oximeter and spun hematocrit (micro centrifuge) methodologies have been conducted by evaluating over 400 split-samples at four clinical sites. Shown below is the performance of a representative site:

Analyte	n	Slope	r	Intercept	Std Error Sy.x
pH	120	0.89	0.99	0.841	0.013
pCO2	114	0.84	0.99	5.93	1.03
pO2	119	1.02	1.00	-0.08	5.77
Na+	120	0.98	0.89	3.04	2.48
K+	120	1.01	0.99	-0.15	0.07
iCa++	118	0.85	0.94	0.17	0.03
Hct	102	1.11	0.93	-4.03	2.55

Reference Device: Corning 865 and CO-oximeter module

Hospital Operating Room Point-Of-Care .

The SenDx 100™ system was subjected to operating room point-of-care use and at two different hospitals, operated by typical OR personnel. Shown below is the performance of a representative site:

Analvte	n	Slope	r	Intercept	Std ErrorSy.x
pH	112	0.78	0.99	1.66	0.01
pCO2	106	0.80	0.96	4.96	1.56
pO2	108	0.79	0.95	54	28.5
Na+	112	0.85	0.90	17.1	1.98
K+	112	1.06	0.98	-0.4	0.20
iCa++	97	0.88	0.95	0.12	0.06
Hct	111	1.03	0.99	-2.35	1.85

Reference Device: Mallinckrodt Gem-Premier

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Hospital Stat Lab �

Precision studies of the SenDx 100™ were conducted at four clinical sites over a five-day period. Reference quality control materials for pH, blood gases, electrolytes and hematocrit were tested. Each level was run in duplicate twice a day. Shown below are summarized precision data collected from these clinical sites:

Reference Device: Corning 865 and Co-oximeter Module

	Mean	Level 1S. D.	% CV	Mean	Level 2S. D.	% CV	Mean	Level 3S. D.	% CV
					6 3 3 3		,在此次	الموالي الموالي	ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘ
DE EXPWithin Run	7.188	,一起,0.001	이 기자 100.020	7.416	0.007	0.010	7.599	0.002	0.028
Within Day	7.188	0.001	0.013	7.416	0.001	0.017	7.601	0.003	0.035
Day to Day	7.193	0.003	0.046	7.423	0.004	0.029	7.607	0.005	0.072
Site to Site*	7.192	0.007	0.100	7.422	0.008	0.102	7.602	0.006	0.075
pCO2 .				Shop The			ર્વારા તા	的一个人
Within Run	67.7	0.354	0.523	Production of the46.8	0.000	0.000	想的一个感情24.1	0.354	1.470
Within Day	67.9	0.374	0.551	47.0	0.238	0.507	23.9	0.263	1.099
Day to Day	67.6	0.642	0.952	46.0	1.015	2.216	23.9	0.760	3.332
Site to Site*	66.4	1.883	2.835	44.5	1.098	2.470	23.3	0.385	1.653
po2 po2	사	ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘ	100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000				,	ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘ
Within Run	68.5	0.636	0.930	106.8	1.061	0.994	144.5	0.071	0.049
Within Day	68.2	1.049	1.538	106.5	0.707	0.664	144.4	0.419	0.290
Day to Day	68.0	1.433	1.937	106.2	0.953	0.877	143.6	0.789	0.543
Site to Site*	68.2	2.502	3.667	107.4	1.328	1.236	143.1	2.546	1.779
1 Naje J		1. Sales of the	ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘ	,	儿的母婴儿		이러한 이름이 있		a ka
Within Run	108.1	0.141	0.131	129.8	0.071	0.054	157.4	0.424	0.270
Within Day	108.0	0.263	0.244	129.8	0.141	0.109	157.1	0.432	0.275
Day to Day	108.0	0.455	0.421	129.7	0.234	0.180	156.5	0.454	0.290
Site to Site*	107.4	2.133	1.987	129.2	1.452	1.124	156.2	1.176	0.753
AK K	રે રું	ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘ	ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘ	الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموق		an de la p			ﺍﻟﻤﺴﺎﻋﺪ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘ
Within Run	1.80	0.028	1.571	4.37	0.028	0.647	6.50	0.007	0.109
Within Day	1.80	0.017	0.950	4.38	0.030	0.681	6.48	0.021	0.318
Day to Day	1.81	0.013	0.716	4.37	0.015	0.347	6.46	0.031	0.477
Site to Site*	1.81	0.019	1.055	4.35	0.036	0.822	6.43	0.047	0.728
PriCattle		のお得な	ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤ		14.08		,但是
Within Run	1.56	0.042	2.720	1.17	0.000	0.000	0.49	0.000	0.000
Within Day	1.55	0.029	1.856	1.16	0.015	1.290	0.50	0.006	1.166
Day to Day	1.55	0.019	1.236	1.16	0.009	0.763	0.50	0.004	0.714
Site to Site*	1.52	0.045	2.959	1.15	0.021	1.841	0.49	0.008	1.681
Hotel Hotel	::			- 北海		,
Within Run	35.4	0.212	0.600	58.7	0.071	0.121
Within Day	35.4	0.173	0.490	58.7	0.141	0.241
Day to Day	34.8	0.425	1.220	57.8	0.722	1.249
Site to Site*	34.2	0.546	1.594	57.3	0.797	1.391

SUMMARY OF PRECISION STUDY

For three clinical sites.

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CONCLUSION FROM NONCLINICAL AND CLINICAL TESTING

From the nonclinical data we conclude that the performance of the SenDx 100™ system is equivalent to that of the Mallinckrodt GEM-PREMIER, Corning 865 and spun hematocrit for measurement of pH, pO2, pCO2, Na*, K*, Cli, iCa** and hematocrit.

From the clinical study data we conclude that the performance of the SenDx 100™ system is substantially equivalent to that of the predicate devices routinely employed at the clinical sites, for measurement of pH, pO3, pCO2, Na K*, iCa* and hematocrit. From these nonclinical and clinical studies we conclude that the performance of the SenDx 100™ system is substantially equivalent to that of the predicate devices routinely employed at several clinical sites.

These data adequately show that the SenDx 100™ system is safe and effective for its intended use in the laboratory or point-of-care. The data shows the SenDx 100™ system can be used at clinical sites for equivalent performance to the predicate devices routinely in use.

R. Chans

Signature of applicant

Sept. 29, 1997
Date

Date

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Image /page/13/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes entwined around it, representing medicine and health. The seal is in black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC - 3 1997

Ruben Chairez, Ph.D. . Vice President, Regulatory Affairs/Quality Assurance SenDx Medical, Inc. 1945 Palomar Oaks Way Carlsbad, California 92009

Re : K973742 SenDx 100 pH, Blood Gas and Electrolyte Analysis System Regulatory Class: II CHL, CGZ, CEM, JFP, JGS, GKF Product Code: Dated: September 23, 1997 Received: October 1, 1997

Dear Dr. Chairez:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{14}------------------------------------------------

Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Bitman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{15}------------------------------------------------

510(k) PRE-MARKET NOTIFICATION 510(k) PRE-MARKET NOTIFICATION

SenDx 100 pH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM

Ka73742

510(k) Number (if known):

SenDx 100™ pH, Blood Gas and Electrolyte Analysis System Device Name:

Indications for Use:

The SenDx 100™ pH, Blood Gas and Electrolyte Analysis System (SenDx 100™) is The SellDX 100 - p11, D100 Gar ara Love Story Corporation, potassium, chloride, ionized calcium and hematocrit in whole blood.

The SenDx 100™ system can be used in the laboratory, near patient, or in point-of-care The SellDX 100" System can oo abou in the tas binn the tass of electrolytes and hematocrit in arterial or venous whole blood samples.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUED ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Clinical Laboratory Devices

510(k) Number	K973742
---------------	---------

Prescription Use(Per 21 CFR 801.109)	OR	Over-the-Counter Use
------------------------------------------	----	----------------------

(Optional Format 1-2-96)

Regulation Number and Section

§ 862.1170 Chloride test system.

(a)
Identification. A chloride test system is a device intended to measure the level of chloride in plasma, serum, sweat, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.(b)
Classification. Class II.