The S-Test Total Bilirubin Reagent is intended for the quantitative determination of bilirubin in serum or heparin plasma using the S40 Clinical Analyzer. Measurements of the levels 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. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The S-Test Blood Urea Nitrogen Reagent is intended for the quantitative determination of urea nitrogen in serum or heparin plasma using the S40 Clinical Analyzer. Measurements of Urea Nitrogen are used in the diagnosis and treatment of certain renal and metabolic diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The S-Test Glucose Reagent is intended for the quantitative determination of glucose in serum or heparin plasma using the S40 Clinical Analyzer. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and pancreatic islet cell carcinoma. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

Device Description

The S40 Clinical Analyzer is an automatic wet chemistry system intended for use in clinical laboratories or physician office laboratories that consists of a desktop analyzer, an operation screen that prompts the user for operation input and displays data, a unit cover, and disposable reagent cartridges. The desktop analyzer includes a single pipettor, an incubation rotor, and a multi-wavelength photometer. The analyzer can measure analytes in serum, heparin plasma, whole blood, and urine.

Once the sample is placed into the device, the analyzer pipettes the sample, pipettes the reagent, and mixes the sample and reagent together. After the sample and reagent react in the incubator bath, the analyzer measures the absorbance of the sample, and based on the absorbance, it calculates the concentration of analyte in the sample.

The S-Test total bilirubin (BIL) reagent cartridge used with the S40 Clinical Analyzer is intended for quantitative in vitro diagnostic determination of total BIL by measuring bilirubin concentration in serum or heparin plasma based on an enzymatic photometric test measuring the formation of biliverdine from bilirubin.

The S-Test blood urea nitrogen (BUN) reagent cartridge used with the S40 Clinical Analyzer is intended for quantitative in vitro diagnostic determination of BUN in serum or heparin plasma based on an enzymatic photometric test measuring the formation of NADP from NADPH.

The S-Test glucose (GLU) reagent cartridge used with the S40 Clinical Analyzer is intended for quantitative in vitro diagnostic determination of GLU in serum or heparin plasma based on an enzymatic photometric test measuring the formation of NADPH from NADP.

AI/ML Overview

The provided text describes the performance data for three S-Test reagents (BIL, BUN, GLU) used with the S40 Clinical Analyzer, as submitted in a 510(k) summary to the FDA. The information focuses on precision, accuracy, and sensitivity.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" as a pre-defined set of thresholds that the device must meet. Instead, it presents performance data (precision, accuracy, sensitivity) and then concludes that "Based on the foregoing data, the device is safe and effective. These data also indicate substantial equivalence to the predicate devices." This implies that the reported performance metrics were considered acceptable for demonstrating substantial equivalence.

Given this, the table below will present the reported device performance for each metric. The "Acceptance Criteria" column will reflect the implied criteria based on the predicates and the FDA's ultimate determination of substantial equivalence (i.e., the reported performance was accepted). Without direct numerical acceptance criteria, the "Acceptance Criteria" will be a qualitative statement reflecting the goal of achieving performance comparable to predicate devices and being considered safe and effective.

Test Parameter	Metric	Acceptance Criteria (Implied)	Reported Device Performance
S-Test BIL	Precision	Comparable to predicate devices; safe and effective	Within-run CV: 0.0 - 10.7%; Total CV: 0.0 - 13.3%
	Accuracy (Correlation)	Correlation coefficient and regression analysis indicating strong agreement with a comparison method.	Correlation Coefficient: 0.996 - 0.998 Standard Error Estimate: 0.48 - 0.53 Confidence Interval Slope: 0.926 - 1.125 Confidence Interval Intercept: 0.00 - 0.30
	Sensitivity	Detection limit allowing for intended clinical use	Detection Limit: 0.2 mg/dL
S-Test BUN	Precision	Comparable to predicate devices; safe and effective	Within-run CV: 0.7 - 2.5%; Total CV: 0.9 - 6.6%
	Accuracy (Correlation)	Correlation coefficient and regression analysis indicating strong agreement with a comparison method.	Correlation Coefficient: 0.996 - 0.997 Standard Error Estimate: 0.9 - 1.83 Confidence Interval Slope: 0.922 - 1.040 Confidence Interval Intercept: -2.11 - 1.47
	Sensitivity	Detection limit allowing for intended clinical use	Detection Limit: 4.9 mg/dL
S-Test GLU	Precision	Comparable to predicate devices; safe and effective	Within-run CV: 1.1 - 2.9%; Total CV: 1.3 - 6.6%
	Accuracy (Correlation)	Correlation coefficient and regression analysis indicating strong agreement with a comparison method.	Correlation Coefficient: 0.989 - 0.998 Standard Error Estimate: 7.4 - 16.0 Confidence Interval Slope: 0.994 - 1.133 Confidence Interval Intercept: -17.5 - -1.87
	Sensitivity	Detection limit allowing for intended clinical use	Detection Limit: 18 mg/dL

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

S-Test BIL: 91 samples for the main correlation study; additional "patient correlation studies" were done at three Physician Office Laboratory (POL) sites. The provenance (country of origin, retrospective/prospective) is not specified, but the use of "patient correlation studies" suggests prospective collection of clinical samples for accuracy comparisons. Precision studies were conducted over 22 days and 5 days (in-house and at POL sites) using unknown types of samples (e.g., control materials, patient samples).
S-Test BUN: 94 samples for the main correlation study; additional "patient correlation studies" were done at four POL sites. Similar to BIL, provenance is not specified, but "patient correlation studies" suggest prospective clinical data. Precision studies were conducted over 22 days and 5 days (in-house and at POL sites).
S-Test GLU: 97 samples for the main correlation study; additional "patient correlation studies" were done at four POL sites. Similar to BIL and BUN, provenance is not specified, but "patient correlation studies" suggest prospective clinical data. Precision studies were conducted over 22 days and 5 days (in-house and at POL sites).

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

The document does not mention the use of "experts" in the context of establishing ground truth. For these types of in vitro diagnostic devices, the "ground truth" for accuracy studies is typically established by measurements from a "comparison method" (often a well-established, previously cleared or gold-standard laboratory instrument/method). The qualifications of those performing the comparison method are not specified.

4. Adjudication Method for the Test Set:

Not applicable. This device is an automated chemistry analyzer. The ground truth for accuracy studies is based on a comparison to a referent laboratory method, not on human adjudication or consensus.

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 device is an automated in vitro diagnostic instrument/reagent system, not an AI-assisted diagnostic imaging or interpretation system requiring human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Yes, the performance data presented (precision, accuracy, sensitivity) is for the device operating in a standalone manner, meaning the S40 Clinical Analyzer using the S-Test reagents without human interpretation influencing the measurement results beyond standard laboratory practices. The "accuracy" studies compare the device's measurements directly to a comparison method.

7. The Type of Ground Truth Used:

The ground truth used for the accuracy studies was established by a "comparison method", which is another established laboratory instrument or reagent system. For example, for BIL, BUN, and GLU, the S40 Clinical Analyzer's results were compared to those from an unnamed "comparison method." This is a common practice for IVD devices to demonstrate substantial equivalence to existing technologies.

8. The Sample Size for the Training Set:

The document does not explicitly mention a "training set" in the context of algorithm development, as this type of chemistry analyzer likely relies on established analytical principles rather than machine learning algorithms that require explicit training. The precision and accuracy studies are typically validation studies performed on the final device, not training.

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

As there is no mention of a "training set" or explicit algorithm development (in the machine learning sense), this question is not applicable to the provided information. If there were internal method development phases, the ground truth would similarly be established by reference methods or gravimetric/volumetric standards for calibrators and controls.

Summary

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Korriyo

JUN 2 4 2008

510(k) SUMMARY

510(k) Owner:	Alfa Wassermann Diagnostic Technology, LLC4 Henderson DriveWest Caldwell, NJ 07006
Contact:	Dennis TaschekPhone: 973-852-0177Fax: 973-852-0237
Date Summary Prepared:	June 19, 2008
Device:	Trade Name:	S-Test BIL; S-Test BUN; S-Test GLU Reagent cartridge(21 C.F.R. § 862.1110, Product code JFM; 21 C.F.R. § 862.1770, Product code CDQ; 21 C.F.R. § 862.1345, Product code CFR)
	Classification:	Class II
	Common/Classification Name:	Total bilirubin; blood urea nitrogen; glucose test systems
Predicate Devices:	Manufacturers for analyzer/reagent system predicates are:
	1. ACE plus ISE/ Clinical Chemistry SystemACE Total Bilirubin Reagent (K931786)ACE BUN Reagent (K931786)ACE GLU Reagent (K931786)
	2. Olympus AU640 Clinical Chemistry AnalyzerTotal Bilirubin Reagent (K961274)BUN Reagent (K961274)GLU Reagent (K961274)
	3. Piccolo® xpress Chemistry AnalyzerTotal Bilirubin Reagent (K942782)BUN Reagent (K942782)GLU Reagent (K942782)
Device Description:	The S40 Clinical Analyzer is an automatic wet chemistry system intended for use in clinical laboratories or physician office laboratories that consists of a desktop analyzer, an operation screen that prompts the user for operation input and displays data, a unit cover, and disposable reagent cartridges. The desktop analyzer includes a single pipettor, an incubation rotor, and a multi-wavelength photometer. The analyzer can measure analytes in serum, heparin
	plasma, whole blood, and urine.
	Once the sample is placed into the device, the analyzer pipettes the sample,pipettes the reagent, and mixes the sample and reagent together. After thesample and reagent react in the incubator bath, the analyzer measures theabsorbance of the sample, and based on the absorbance, it calculates theconcentration of analyte in the sample.
	The S-Test total bilirubin (BIL) reagent cartridge used with the S40 ClinicalAnalyzer is intended for quantitative in vitro diagnostic determination of totalBIL by measuring bilirubin concentration in serum or heparin plasma based onan enzymatic photometric test measuring the formation of biliverdine frombilirubin.
	The S-Test blood urea nitrogen (BUN) reagent cartridge used with the S40Clinical Analyzer is intended for quantitative in vitro diagnostic determinationof BUN in serum or heparin plasma based on an enzymatic photometric testmeasuring the formation of NADP from NADPH.
	The S-Test glucose (GLU) reagent cartridge used with the S40 ClinicalAnalyzer is intended for quantitative in vitro diagnostic determination of GLUin serum or heparin plasma based on an enzymatic photometric test measuringthe formation of NADPH from NADP.
Intended Use:	The S-Test Total Bilirubin Reagent is intended for the quantitativedetermination of bilirubin in serum or heparin plasma using the S40 ClinicalAnalyzer. Measurements of the levels of bilirubin, an organic compoundformed during the normal and abnormal destruction of red blood cells, are usedin the diagnosis and treatment of liver, hemolytic hematological, and metabolicdisorders, including hepatitis and gall bladder block. This test is intended foruse in clinical laboratories or physician office laboratories. For in vitrodiagnostic use only.
	The S-Test Blood Urea Nitrogen Reagent is intended for the quantitativedetermination of urea nitrogen in serum or heparin plasma using the S40Clinical Analyzer. Measurements of Urea Nitrogen are used in the diagnosisand treatment of certain renal and metabolic diseases. This test is intended foruse in clinical laboratories or physician office laboratories. For in vitrodiagnostic use only.
	The S-Test Glucose Reagent is intended for the quantitative determination ofglucose in serum or heparin plasma using the S40 Clinical Analyzer. Glucosemeasurements are used in the diagnosis and treatment of carbohydratemetabolism disorders including diabetes mellitus, neonatal hypoglycemia,idiopathic hypoglycemia, and pancreatic islet cell carcinoma. This test isintended for use in clinical laboratories or physician office laboratories. For invitro diagnostic use only.
TechnologicalCharacteristics:	The S-Test BIL is a bi-reagent cartridge. Reagent 1 and Reagent 2 bothcontain bilirubin oxidase (BOD) (2000-6000 U/L) and buffer.
	The S-Test BUN is a bi-reagent cartridge. Reagent 1 contains: nicotinamideadenine dinucleotide phosphate (NADPH, reduced form), carbonate buffer (pH10), and Good's buffer (pH 6.0). Reagent 2 contains: urease (derived fromsword bean), glutamate dehydrogenase (GLDH) (derived from yeast), andN,N-bis (2-hydroxyethyl) glycine (BICINE) buffer (pH 8.2).
	The S-Test GLU is a bi-reagent cartridge. Reagent 1 contains: hexokinase(HK) (derived from yeast), glucose-6-phosphate dehydrogenase (G-6-PDH,derived from bacillus), nicotinamide adenine dinucleotide phosphate (NADP,oxidized type), and magnesium acetate 2-amino-2-hydroxymethyl-1,3-propanediol buffer (pH 9.0). Reagent 2 contains: adenosine triphosphatedisodium salt (ATP), and 2-amino-2-hydroxymethyl 1,3-propanediol buffer(pH 9.0).
PerformanceData:	Performance data on the S-Test BIL, S-Test BUN, and S-Test GLU includedprecision, accuracy, and sensitivity data.
	S-Test BIL
	Precision: In testing conducted at three BIL levels for 22 days, the within-runCV ranged from 0.9 to 10.7%, and total CV ranged from 5.2 to 13.3%. Inprecision studies at three separate Physician Office Laboratory (POL) sites andin-house over five days, the within-run CV ranged from 0.0 to 10.4% and thetotal CV ranged from 0.0 to 10.4%.
	Accuracy: In the correlation study, 91 samples with BIL values ranging from0.2 to 23.9 mg/dL were assayed on the S40 Clinical Analyzer using S-Test BILreagent and a comparison method. Least-squares regression analysis yielded acorrelation coefficient of 0.996, a standard error estimate of 0.5, a confidenceinterval slope of 0.963 to 1.125, and a confidence interval intercept of 0.00 to0.15. In patient correlation studies at three separate POL sites using the S40Clinical Analyzer and a comparative method, least-squares regression analysisyielded correlation coefficients ranged from 0.997 to 0.998, standard errorestimates of 0.48 to 0.53, confidence interval slopes of 0.926 to 0.981, andconfidence interval intercepts of 0.02 to 0.30.
	Sensitivity: The detection limit was 0.2 mg/dL.
	S-Test BUN
	Precision: In testing at three BUN levels for 22 days, the within-run CV rangedfrom 1.2 to 2.3%, and total CV ranged from 6.2 to 6.6%. In precision studiesat three separate POL sites and in-house over five days, the within-run CVranged from 0.7 to 2.5% and total CV ranged from 0.9 to 2.5%.
	Accuracy: In the correlation study, 94 samples with BUN values ranging from6 to 70 mg/dL were assayed on the S40 Clinical Analyzer using S-Test BUN
	reagent and a comparison method. Least-squares regression analysis yielded a correlation coefficient of 0.997, a standard error estimate of 0.9, a confidence interval slope of 0.979 to 1.040, and a confidence interval intercept of 0.34 to 1.47. In patient correlation studies at four separate POL sites using the S40 Clinical Analyzer and a comparative method, least-squares regression analysis yielded correlation coefficients ranged from 0.996 to 0.997, standard error estimates of 1.11 to 1.83, confidence interval slopes of 0.922 to 1.012, and confidence interval intercepts of -2.11 to 1.30.
	Sensitivity: The detection limit was 4.9 mg/dL.
	S-Test GLU
	Precision: In testing conducted at three GLU levels for 22 days, the within-run CV ranged from 1.4 to 1.8%, and the total CV ranged from 5.8 to 6.6%. In precision studies at three separate POL sites and in-house over five days, the within-run CV ranged from 1.1 to 2.9%, and the total CV ranged from 1.3 to 3.4%.
	Accuracy: In the correlation study, 97 samples with GLU values ranging from 26 to 454 mg/dL were assayed on the S40 Clinical Analyzer using S-Test GLU and on a comparison method. Least-squares regression analysis yielded a correlation coefficient of 0.996, a standard error estimate of 7.4, a confidence interval slope of 0.994 to 1.073, and a confidence interval intercept of -10.3 to -1.87. In patient correlation studies at four separate POL sites using the S40 Clinical Analyzer and a comparative method, least-squares regression analysis yielded correlation coefficients ranging from 0.989 to 0.998, standard error estimates of 7.7 to 16.0, confidence interval slopes of 1.044 to 1.133, and confidence interval intercept of -17.5 to -2.6.
	Sensitivity: The detection limit was 18 mg/dL.
Conclusions:	Based on the foregoing data, the device is safe and effective. These data also indicate substantial equivalence to the predicate devices.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wings, representing health, human services, and the department's commitment to serving the nation. The eagle is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in all caps.

Public Health Service

Food and Druq Administration 2098 Gaither Road Rockville MD 20850

Alfa Wassermann Diagnostic Technology, Inc. c/o Mr. Dennis Tascheck Vice President, Reagent & Instrument Technologies 4 Henderson Drive West Caldwell, NJ 07006

JUN 2 4 2008

Re: K072140

Trade Name: S-Test Glucose (GLU), S-Test Total Bilirubin (BIL), S-Test Blood Urca Nitrogen (BUN) Regulation Number: 21 CFR 862.1770 Regulation Name: Urea Nitrogen Test System. Regulatory Class: Class II Product Codes: CDN, JFM, CFR, JJE Dated: June 16, 2008 Received: June 17, 2008

Dear Mr. Tascheck:

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) 276-0490. 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 tolloffree ne (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Cooper, M.S., D.v.M.

Jean M. Cooper, M.S., D.V.M. 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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510(k) Number (if known): K072140

Device Name: S40 Clinical Analyzer

Indication For Use:

X Prescription Use (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of & DRH, Office of Jn Vitro Diagnostic Device Evaluation and Safety (OVD)

tom getn
RC172140

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K072140

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510(k) Number (if known): K072140

Device Name: S-Test Glucose (GLU)

Indication For Use:

Prescription Use X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K073140

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510(k) Number (if known): K072140

Device Name: S-Test Total Bilirubin (BIL)

Indication For Use:

Prescription Use · X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use _ (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K017140

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510(k) Number (if known): K072140

Device Name: S-Test Blood Urea Nitrogen (BUN)

Indication For Use:

The S-Test Blood Urea Nitrogen Reagent is intended for the quantitative determination of urca nitrogen in serum or heparin plasma using the S40 Clinical Analyzer. Measurements of Urea Nitrogen are used in the diagnosis and treatment of certain renal and metabolic diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

Prescription Use X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

signature

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K070148

Regulation Number and Section

§ 862.1345 Glucose test system.

(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.